ClinicalTrials.gg
CompletedNCT05272787Updated Jun 29, 2023

Clinical Trial to Evaluate Safety and Efficacy of a Facial and Lip Moisturizer in Adult Subjects Undergoing a Facial Dermatologic Procedure With Fractional CO2 Laser

An interventional study of TH Facial Moisturizer and TH Lip Moisturizer in Skin Regeneration After Dermatological Facial Procedure With Fractional CO2 Laser, sponsored by Johnson & Johnson Consumer Inc. (J&JCI). Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-29.

Sponsored by Johnson & Johnson Consumer Inc. (J&JCI) (formerly part of Johnson & Johnson) · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is study aims to evaluate the topical safety (tolerability/acceptability) and efficacy of TH Facial Moisturizer and TH Lip Moisturizer Investigational products after 21 ± 2 days of use under normal conditions on the half-face by adult participants who underwent dermatological facial procedure with fractional CO2 Laser under the supervision of a dermatologist. For these investigational products, safety parameters, clinical efficacy, instrumental efficacy (skin hydration, skin barrier integrity and facial imaging) and perceived efficacy through subjective perception questionnaires will be evaluated. Subjects will receive the product to use it at home for 21 +/- 2 days.

02

Conditions studied

  • Skin Regeneration After Dermatological Facial Procedure With Fractional CO2 Laser
03

In context

Lead sponsor

Johnson & Johnson Consumer Inc. (J&JCI) is the lead sponsor of 55 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.

First submitted before Johnson & Johnson Consumer Inc. (J&JCI) left Johnson & Johnson.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and/or Female
  • 18 to 65 years old
  • Fitzpatrick Skin Type I to III
  • Generally in good health based on medical history reported by the subject.
  • Subjects presenting dry/dried up lips, proven by dermatologist.
  • Subjects who have some cutaneous condition whose performance of the Fractional CO2 Laser procedure is recommended by the dermatologist, for example facial spots and/or acne scars and/or facial wrinkles.
  • Able to read, write, speak, and understand Portuguese.
  • Individual has signed the ICD.
  • Agree to the performance of the Fractional CO2 Laser procedure by the dermatologist.
  • Agree to use two facial products, each on one half face, and one lip product.
  • Agree to use the facial sunscreen provided during the conditioning period and during sun exposure.
  • Agree to replace their usual facial wash with the facial wash provided for facial cleansing during the conditioning period and during the study.
  • For male participants: agree to shave the day before visits 2, 4 and 5.
  • Intends to complete the study and is willing and able to follow all study instructions.

Exclusion criteria

Exclusion Criteria:

  • Has known allergies or adverse reactions to common topical skincare products including facial moisturizer, sunscreen and liquid soap.
  • Have known allergies or adverse reactions to the Pliaglis anesthetic cream that will be used for the dermatological facial procedure.
  • Presents with a skin condition that may confound the study results (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer).
  • Presents with primary/secondary lesions (scar - except from acne, ulcers, vesicles) or tattoos on test sites.
  • Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.
  • Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:
  • Immunosuppressive or steroidal drugs within 2 months before Visit 1*
  • Non-steroidal anti-inflammatory drugs within 5 days before Visit 1*
  • Antihistamines within 2 weeks before Visit 1*

    * If an individual is taking one of these medication types, the individual is not considered eligible at screening. However, if a subject begins using one of these medications during the study, the Study Physician should be consulted to consider the impact of the specific medication on subject safety and/or the study results, as described in section "Concurrent/Concomitant Medication".

  • Is self-reported to be pregnant or planning to become pregnant during the study.
  • Subjects with a history of keloid formation.
  • Subject with a history of Herpes.
  • Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study.
  • Test positive for COVID-19 at visit 2 according to the rapid antigen test (COVID-19 Ag Immuno-Rapid Kit).
  • Is simultaneously participating in any other clinical study.
  • Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor.
  • History of a confirmed COVID-19 infection in the last 30 days.
  • Contact with COVID-19-infected person within 14 days prior to all on-site visits.
  • Any international travel within 14 days prior to all on-site visits including members in the same household.
  • Subjects with self-reported symptoms within the past 2 weeks:
  • Unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomach aches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, fever, or chest pain/tightness.
  • Temperature ≥ 38.0°C /100.4°F, measured.
  • Use of fever reducers within the past 2 days of each onsite visit.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Left face TH Facial Moisturizer

    All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home. The choice of the half face on which the product will be applied will be defined by a randomization list, prepared by the statistician in charge. If the TH Facial Moisturizer will be applied on the left side of the face, then the Facial Moisturizer B (Control) will be applied on the right side of the face. Lip moisturizer, facial wash and sunscreen will be applied in all arms of the study.

    Other: TH Facial Moisturizer · Other: TH Lip Moisturizer · Other: Facial Moisturizer B (Control) · Other: Sunscreen · Other: Facial wash

  • Experimental
    Right face TH Facial Moisturizer

    All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home. The choice of the half face on which the product will be applied will be defined by a randomization list, prepared by the statistician in charge. If the TH Facial Moisturizer will be applied on the right side of the face, then the Facial Moisturizer B (Control) will be applied on the left side of the face. Lip moisturizer, facial wash and sunscreen will be applied in all arms of the study.

    Other: TH Facial Moisturizer · Other: TH Lip Moisturizer · Other: Facial Moisturizer B (Control) · Other: Sunscreen · Other: Facial wash

Interventions

  • OtherTH Facial Moisturizer

    All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home.

    Also known as: The Facial lotion product is a moisturizing formulation intended for topical use on the half-face. It will be applied at least twice daily.

  • OtherTH Lip Moisturizer

    All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home.

    Also known as: The lip lotion product is a moisturizing formulation intended for topical use on the lips. It will be applied at least twice daily.

  • OtherFacial Moisturizer B (Control)

    All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home.

    Also known as: The Facial lotion product is a moisturizing formulation intended for topical use on the half-face. It will be applied at least twice daily.

  • OtherSunscreen

    Auxiliary product

    Also known as: It will be used all over the face whenever there is the intention of sun exposure.

  • OtherFacial wash

    Auxiliary product.

    Also known as: It will be used to wash the face at least once daily.

06

What researchers measure

Primary outcomes

  1. Change from baseline of scores of erythema to 21 ± 2 days.

    At baseline and at 21 ± 2 days, the study physician will evaluate the whole face (including lips) and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole face (including lips). The change from baseline will be evaluated to assess skin tolerance of the TH Facial moiturizer and TH Lip moisturizer.

    Time frame: 21 ± 2 days.

  2. Change from baseline of the scores of desquamation to 21 ± 2 days.

    At baseline and at 21 ± 2 days, the study physician will evaluate the whole face (including lips) and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole face (including lips). The change from baseline will be evaluated to assess skin tolerance of the TH Facial moiturizer and TH Lip moisturizer.

    Time frame: 21 ± 2 days.

  3. Change from baseline of the scores of blistering to 21 ± 2 days.

    At baseline and at 21 ± 2 days, the study physician will evaluate the whole face (including lips) and score the identified blisterings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole face (including lips). The change from baseline will be evaluated to assess skin tolerance of the TH Facial moiturizer and TH Lip moisturizer.

    Time frame: 21 ± 2 days.

  4. Change from baseline of the scores of edema to 21 ± 2 days.

    At baseline and at 21 ± 2 days, the study physician will evaluate the whole face (including lips) and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole face (including lips). The change from baseline will be evaluated to assess skin tolerance of the TH Facial moiturizer and TH Lip moisturizer.

    Time frame: 21 ± 2 days.

  5. Percentage of participants with Adverse Events through 21 ± 2 days.

    The percentage of participants with AEs, serious adverse events (SAEs), AEs leading to discontinuation and AEs related to skin reactions will be evaluated for skin tolerance up to 21 ± 2 days.

    Time frame: 21 ± 2 days.

Secondary outcomes

  1. Change from baseline of the scores of erythema to 21 ± 2 days for TH facial moisturizer.

    At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 21 ± 2 days.

  2. Change from baseline of the scores of erythema to 21 ± 2 days for Facial Moisturizer B (Control).

    At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 21 ± 2 days.

  3. Comparison of erythema scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)

    At 21 ± 2 days, the study physician will evaluate both half faces and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 21 ± 2 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: 21 ± 2 days.

  4. Change from baseline of the scores of erythema to 5 ± 1 day for TH facial moisturizer.

    At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 5 ± 1 day.

  5. Change from baseline of the scores of erythema to 5 ± 1 day for Facial Moisturizer B (Control).

    At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 5 ± 1 day.

  6. Comparison of erythema scores at5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)

    At 5 ± 1 day, the study physician will evaluate both half faces and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 5 ± 1 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 5 ± 1 day.

  7. Change from baseline of the scores of erythema to 24 hours for TH facial moisturizer.

    At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 24 hours.

  8. Change from baseline of the scores of erythema to 24 hours for Facial Moisturizer B (Control).

    At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 24 hours.

  9. Comparison of erythema scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)

    At 24 hours, the study physician will evaluate both half faces and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 24 hours scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 24 hours.

  10. Change from baseline of the scores of erythema to 1 hour for TH facial moisturizer.

    At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 1 hour.

  11. Change from baseline of the scores of erythema to 1 hour for Facial Moisturizer B (Control).

    At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 1 hour.

  12. Comparison of erythema scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)

    At 1 hour, the study physician will evaluate both half faces and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 1-hour scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 1 hour.

  13. Change from baseline of the scores of erythema to 30 minutes for TH facial moisturizer.

    At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 30 minutes.

  14. Change from baseline of the scores of erythema to 30 minutes for Facial Moisturizer B (Control).

    At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 30 minutes.

  15. Comparison of erythema scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)

    At 30 minutes, the study physician will evaluate both half faces and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 30 minutes scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 30 minutes.

  16. Change from baseline of the scores of edema to 21 ± 2 days for TH facial moisturizer.

    At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 21 ± 2 days.

  17. Change from baseline of the scores of edema to 21 ± 2 days for Facial Moisturizer B (Control).

    At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 21 ± 2 days.

  18. Comparison of edema scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)

    At 21 ± 2 days, the study physician will evaluate both half faces and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 21 ± 2 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 21 ± 2 days.

  19. Change from baseline of the scores of edema to 5 ± 1 day for TH facial moisturizer.

    At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 5 ± 1 day.

  20. Change from baseline of the scores of edema to 5 ± 1 day for Facial Moisturizer B (Control).

    At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 5 ± 1 day.

  21. Comparison of edema scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)

    At 5 ± 1 day, the study physician will evaluate both half faces and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 5 ± 1 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 5 ± 1 day.

  22. Change from baseline of the scores of edema to 24 hours for TH facial moisturizer.

    At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 24 hours.

  23. Change from baseline of the scores of edema to 24 hours for Facial Moisturizer B (Control).

    At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 24 hours.

  24. Comparison of edema scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)

    At 24 hours, the study physician will evaluate both half faces and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 24 hours scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 24 hours.

  25. Change from baseline of the scores of edema to 1 hour for TH facial moisturizer.

    At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 1 hour.

  26. Change from baseline of the scores of edema to 1 hour for Facial Moisturizer B (Control).

    At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 1 hour.

  27. Comparison of edema scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)

    At 1 hour, the study physician will evaluate both half faces and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 1-hour scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 1 hour.

  28. Change from baseline of the scores of edema to 30 minutes for TH facial moisturizer.

    At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 30 minutes.

  29. Change from baseline of the scores of edema to 30 minutes for Facial Moisturizer B (Control).

    At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 30 minutes.

  30. Comparison of edema scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)

    At 30 minutes, the study physician will evaluate both half faces and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 30 minutes scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 30 minutes.

  31. Change from baseline of the scores of dryness to 21 ± 2 days for TH facial moisturizer.

    At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 21 ± 2 days.

  32. Change from baseline of the scores of dryness to 21 ± 2 days for Facial Moisturizer B (Control).

    At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 21 ± 2 days.

  33. Comparison of dryness scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)

    At 21 ± 2 days, the study physician will evaluate both half faces and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 21 ± 2 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 21 ± 2 days.

  34. Change from baseline of the scores of dryness to 5 ± 1 day for TH facial moisturizer.

    At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 5 ± 1 day.

  35. Change from baseline of the scores of dryness to 5 ± 1 day for Facial Moisturizer B (Control).

    At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 5 ± 1 day.

  36. Comparison of dryness scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)

    At 5 ± 1 day, the study physician will evaluate both half faces and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 5 ± 1 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 5 ± 1 day.

  37. Change from baseline of the scores of dryness to 24 hours for TH facial moisturizer.

    At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 24 hours.

  38. Change from baseline of the scores of dryness to 24 hours for Facial Moisturizer B (Control).

    At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 24 hours.

  39. Comparison of dryness scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)

    At 24 hours, the study physician will evaluate both half faces and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 24 hours scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 24 hours.

  40. Change from baseline of the scores of dryness to 1 hour for TH facial moisturizer.

    At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 1 hour.

  41. Change from baseline of the scores of dryness to 1 hour for Facial Moisturizer B (Control).

    At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 1 hour.

  42. Comparison of dryness scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)

    At 1 hour, the study physician will evaluate both half faces and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 1-hour scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 1 hour.

  43. Change from baseline of the scores of dryness to 30 minutes for TH facial moisturizer.

    At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 30 minutes.

  44. Change from baseline of the scores of dryness to 30 minutes for Facial Moisturizer B (Control).

    At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 30 minutes.

  45. Comparison of dryness scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)

    At 30 minutes, the study physician will evaluate both half faces and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 30 minutes scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 30 minutes.

  46. Change from baseline of the scores of desquamation to 21 ± 2 days for TH facial moisturizer.

    At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 21 ± 2 days.

  47. Change from baseline of the scores of desquamation to 21 ± 2 days for Facial Moisturizer B (Control).

    At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 21 ± 2 days.

  48. Comparison of desquamation scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)

    At 21 ± 2 days, the study physician will evaluate both half faces and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 21 ± 2 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 21 ± 2 days.

  49. Change from baseline of the scores of desquamation to 5 ± 1 day for TH facial moisturizer.

    At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 5 ± 1 day.

  50. Change from baseline of the scores of desquamation to 5 ± 1 day for Facial Moisturizer B (Control).

    At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 5 ± 1 day.

  51. Comparison of desquamation scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)

    At 5 ± 1 day, the study physician will evaluate both half faces and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 5 ± 1 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 5 ± 1 day.

  52. Change from baseline of the scores of desquamation to 24 hours for TH facial moisturizer.

    At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 24 hours.

  53. Change from baseline of the scores of desquamation to 24 hours for Facial Moisturizer B (Control).

    At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 24 hours.

  54. Comparison of desquamation scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)

    At 24 hours, the study physician will evaluate both half faces and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 24 hours scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 24 hours.

  55. Change from baseline of the scores of desquamation to 1 hour for TH facial moisturizer.

    At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 1 hour.

  56. Change from baseline of the scores of desquamation to 1 hour for Facial Moisturizer B (Control).

    At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 1 hour.

  57. Comparison of desquamation scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)

    At 1 hour, the study physician will evaluate both half faces and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 1-hour scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 1 hour.

  58. Change from baseline of the scores of desquamation to 30 minutes for TH facial moisturizer.

    At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 30 minutes.

  59. Change from baseline of the scores of desquamation to 30 minutes for Facial Moisturizer B (Control).

    At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 30 minutes.

  60. Comparison of desquamation scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)

    At 30 minutes, the study physician will evaluate both half faces and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 30 minutes scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 30 minutes.

  61. Change from baseline of the scores of stinging to 21 ± 2 days for TH facial moisturizer.

    At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 21 ± 2 days.

  62. Change from baseline of the scores of stinging to 21 ± 2 days for Facial Moisturizer B (Control).

    At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 21 ± 2 days.

  63. Comparison of stinging scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)

    At 21 ± 2 days, the study physician will evaluate both half faces and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 21 ± 2 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 21 ± 2 days.

  64. Change from baseline of the scores of stinging to 5 ± 1 day for TH facial moisturizer.

    At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 5 ± 1 day.

  65. Change from baseline of the scores of stinging to 5 ± 1 day for Facial Moisturizer B (Control).

    At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 5 ± 1 day.

  66. Comparison of stinging scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)

    At 5 ± 1 day, the study physician will evaluate both half faces and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 5 ± 1 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 5 ± 1 day.

  67. Change from baseline of the scores of stinging to 24 hours for TH facial moisturizer.

    At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 24 hours.

  68. Change from baseline of the scores of stinging to 24 hours for Facial Moisturizer B (Control).

    At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 24 hours.

  69. Comparison of stinging scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)

    At 24 hours, the study physician will evaluate both half faces and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 24 hours scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 24 hours.

  70. Change from baseline of the scores of stinging to 1 hour for TH facial moisturizer.

    At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 1 hour.

  71. Change from baseline of the scores of stinging to 1 hour for Facial Moisturizer B (Control).

    At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 1 hour.

  72. Comparison of stinging scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)

    At 1 hour, the study physician will evaluate both half faces and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 1-hour scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 1 hour.

  73. Change from baseline of the scores of stinging to 30 minutes for TH facial moisturizer.

    At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 30 minutes.

  74. Change from baseline of the scores of stinging to 30 minutes for Facial Moisturizer B (Control).

    At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 30 minutes.

  75. Comparison of stinging scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)

    At 30 minutes, the study physician will evaluate both half faces and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 30 minutes scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 30 minutes.

  76. Change from baseline of the scores of itching to 21 ± 2 days for TH facial moisturizer.

    At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 21 ± 2 days.

  77. Change from baseline of the scores of itching to 21 ± 2 days for Facial Moisturizer B (Control).

    At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 21 ± 2 days.

  78. Comparison of itching scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)

    At 21 ± 2 days, the study physician will evaluate both half faces and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 21 ± 2 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 21 ± 2 days.

  79. Change from baseline of the scores of itching to 5 ± 1 day for TH facial moisturizer.

    At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 5 ± 1 day.

  80. Change from baseline of the scores of itching to 5 ± 1 day for Facial Moisturizer B (Control).

    At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 5 ± 1 day.

  81. Comparison of itching scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)

    At 5 ± 1 day, the study physician will evaluate both half faces and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 5 ± 1 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 5 ± 1 day.

  82. Change from baseline of the scores of itching to 24 hours for TH facial moisturizer.

    At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 24 hours.

  83. Change from baseline of the scores of itching to 24 hours for Facial Moisturizer B (Control).

    At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 24 hours.

  84. Comparison of itching scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)

    At 24 hours, the study physician will evaluate both half faces and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 24 hours scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 24 hours.

  85. Change from baseline of the scores of itching to 1 hour for TH facial moisturizer.

    At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 1 hour.

  86. Change from baseline of the scores of itching to 1 hour for Facial Moisturizer B (Control).

    At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 1 hour.

  87. Comparison of itching scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)

    At 1 hour, the study physician will evaluate both half faces and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 1-hour scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 1 hour.

  88. Change from baseline of the scores of itching to 30 minutes for TH facial moisturizer.

    At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.

    Time frame: 30 minutes.

  89. Change from baseline of the scores of itching to 30 minutes for Facial Moisturizer B (Control).

    At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).

    Time frame: 30 minutes.

  90. Comparison of itching scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)

    At 30 minutes, the study physician will evaluate both half faces and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify the clinical evaluation on each half face. The 30 minutes scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 30 minutes.

  91. Self-Perceived Efficacy Questionnaire at 30 minutes

    Perceived efficacy related to the product usage will be subjectively evaluated by the participants through a questionnaire with questions related to use of the TH facial moisturizer and TH lip moisturezer produts. Participants will answer each question using a qualitative scale (agreement scale). This questionnaire will be used to evaluate the efficacy of TH Facial Moisturizing and TH Lip Moisturizer regarding skin regeneration after dermatological facial procedure with CO2 fractional laser in adult participants. The responses for each question will be provided as percentages.

    Time frame: 30 minutes

  92. Self-Perceived Efficacy Questionnaire at 24 hours

    Perceived efficacy related to the product usage will be subjectively evaluated by the participants through a questionnaire with questions related to use of the TH facial moisturizer and TH lip moisturezer produts. Participants will answer each question using a qualitative scale (agreement scale). This questionnaire will be used to evaluate the efficacy of TH Facial Moisturizing and TH Lip Moisturizer regarding skin regeneration after dermatological facial procedure with CO2 fractional laser in adult participants. The responses for each question will be provided as percentages.

    Time frame: 24 hours

  93. Self-Perceived Efficacy Questionnaire at 5 ± 1 day

    Perceived efficacy related to the product usage will be subjectively evaluated by the participants through a questionnaire with questions related to use of the TH facial moisturizer and TH lip moisturezer produts. Participants will answer each question using a qualitative scale (agreement scale). This questionnaire will be used to evaluate the efficacy of TH Facial Moisturizing and TH Lip Moisturizer regarding skin regeneration after dermatological facial procedure with CO2 fractional laser in adult participants. The responses for each question will be provided as percentages.

    Time frame: 5 ± 1 day

  94. Self-Perceived Efficacy Questionnaire at 21 ± 2 days

    Perceived efficacy related to the product usage will be subjectively evaluated by the participants through a questionnaire with questions related to use of the TH facial moisturizer and TH lip moisturizer products. Participants will answer each question using a qualitative scale (agreement scale). This questionnaire will be used to evaluate the efficacy of TH Facial Moisturizing and TH Lip Moisturizer regarding skin regeneration after dermatological facial procedure with CO2 fractional laser in adult participants. The responses for each question will be provided as percentages.

    Time frame: 21 ± 2 days

  95. Visual skin condition of the whole face at baseline captured photographically

    Face images will be captured using a recognized device (Visia CR) at baseline to visualize the skin condition of these areas after the dermatological facial procedure with CO2 fractional laser and before the TH Facial moisturizer and Facial Moisturizer B (Control) usage on each determined half face. No analysis is planned. These images will be used as a qualitative complement to the other results for TH Facial moisturizer.

    Time frame: baseline

  96. Visual skin condition of the whole face at 1 hour captured photographically

    Face images will be captured using a recognized device (Visia CR) at 1 hour to visualize the skin condition of these areas after the TH Facial moisturizer and Facial Moisturizer B (Control) supervised application on each determined half face. No analysis is planned. These images will be used as a qualitative complement to the other results for TH Facial moisturizer.

    Time frame: 1 hour

  97. Visual skin condition of the whole face at 24 hours captured photographically

    Face images will be captured using a recognized device (Visia CR) at 24 hours to visualize the skin condition of these areas after the TH Facial moisturizer and Facial Moisturizer B (Control) usage on each determined half face. No analysis is planned. These images will be used as a qualitative complement to the other results for TH Facial moisturizer.

    Time frame: 24 hours

  98. Visual skin condition of the whole face at 5 ± 1 day captured photographically

    Face images will be captured using a recognized device (Visia CR) at 5 ± 1 day to visualize the skin condition of these areas after the TH Facial moisturizer and Facial Moisturizer B (Control) usage on each determined half face. No analysis is planned. These images will be used as a qualitative complement to the other results for TH Facial moisturizer.

    Time frame: 5 ± 1 day

  99. Visual skin condition of the whole face at 21 ± 2 days captured photographically

    Face images will be captured using a recognized device (Visia CR) at 21 ± 2 days to visualize the skin condition of these areas after the TH Facial moisturizer and Facial Moisturizer B (Control) usage on each determined half face. No analysis is planned. These images will be used as a qualitative complement to the other results for TH Facial moisturizer.

    Time frame: 21 ± 2 days

  100. Mean change from baseline to 21 ± 2 days in skin hydration level for TH facial moisturizer.

    Skin hydration level of the determined half face will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of the TH facial moisturizer on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 21 ± 2 days of usage.

    Time frame: 21 ± 2 days

  101. Mean change from baseline to 21 ± 2 days in skin hydration level for Facial Moisturizer B (Control).

    Skin hydration level of the determined half face will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of the Facial Moisturizer B (Control) on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 21 ± 2 days of usage.

    Time frame: 21 ± 2 days

  102. Comparison of skin hydration level at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)

    At 21 ± 2 days, skin hydration level of both half faces will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of both products on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 21 ± 2 days of usage. The 21 ± 2 days measures of each half face will be compared with each other to compare the skin hydration of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 21 ± 2 days.

  103. Mean change from baseline to 24 hours in skin hydration level for TH facial moisturizer.

    Skin hydration level of the determined half face will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of the TH facial moisturizer on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 24 hours of usage.

    Time frame: 24 hours

  104. Mean change from baseline to 24 hours in skin hydration level for Facial Moisturizer B (Control).

    Skin hydration level of the determined half face will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of the Facial Moisturizer B (Control) on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 24 hours of usage.

    Time frame: 24 hours

  105. Comparison of skin hydration level at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)

    At 24 hours, skin hydration level of both half faces will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of both products on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 24 hours of usage. The 24 hours measures of each half face will be compared with each other to compare the skin hydration of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 24 hours.

  106. Mean change from baseline to 1 hour in skin hydration level for TH facial moisturizer.

    Skin hydration level of the determined half face will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of the TH facial moisturizer on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 1 hour of supervised application.

    Time frame: 1 hour

  107. Mean change from baseline to 1 hour in skin hydration level for Facial Moisturizer B (Control).

    Skin hydration level of the determined half face will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of the Facial Moisturizer B (Control) on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser 1 hour of supervised application.

    Time frame: 1 hour

  108. Comparison of skin hydration level at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)

    At 1 hour, skin hydration level of both half faces will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of both products on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser 1 hour of supervised application. The 1-hour measures of each half face will be compared with each other to compare the skin hydration of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 1 hour

  109. Mean change from baseline to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity for TH facial moisturizer.

    Skin barrier integrity of the determined half face will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier. This measure will be used to determine the effect of the TH facial moisturizer on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 21 ± 2 days of usage.

    Time frame: 21 ± 2 days

  110. Mean change from baseline to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity for Facial Moisturizer B (Control).

    Skin barrier integrity of the determined half face will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier. This measure will be used to determine the effect of the Facial Moisturizer B (Control) on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 21 ± 2 days of usage.

    Time frame: 21 ± 2 days

  111. Comparison of transepidermal water loss (TEWL) to assess skin barrier integrity at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)

    At 21 ± 2 days, the transepidermal water loss of both half faces will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier. This measure will be used to determine the effect of both products on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 21 ± 2 days of usage. The 21 ± 2 days measures of each half face will be compared with each other to compare the skin barrier integrity of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 21 ± 2 days.

  112. Mean change from baseline to 24 hours in transepidermal water loss (TEWL) to assess skin barrier integrity for TH facial moisturizer.

    This measure will be used to determine the effect of the TH facial moisturizer on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 24 hours of usage. Skin barrier integrity of the determined half face will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier.

    Time frame: 24 hours

  113. Mean change from baseline to 24 hours in transepidermal water loss (TEWL) to assess skin barrier integrity for Facial Moisturizer B (Control).

    This measure will be used to determine the effect of the Facial Moisturizer B (Control) on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 24 hours of usage. Skin barrier integrity of the determined half face will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier.

    Time frame: 24 hours

  114. Comparison of transepidermal water loss (TEWL) to assess skin barrier integrity at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)

    At 24 hours, the transepidermal water loss of both half faces will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier. This measure will be used to determine the effect of both products on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 24 hours of usage. The 24 hours measures of each half face will be compared with each other to compare the skin barrier integrity of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 24 hours.

  115. Mean change from baseline to 1 hour in transepidermal water loss (TEWL) to assess skin barrier integrity for TH facial moisturizer.

    This measure will be used to determine the effect of the TH facial moisturizer on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 1 hour of supervised application. Skin barrier integrity of the determined half face will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier.

    Time frame: 1 hour

  116. Mean change from baseline to 1 hour in transepidermal water loss (TEWL) to assess skin barrier integrity for Facial Moisturizer B (Control).

    This measure will be used to determine the effect of the Facial Moisturizer B (Control) on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 1 hour of supervised application. Skin barrier integrity of the determined half face will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier.

    Time frame: 1 hour

  117. Comparison of transepidermal water loss (TEWL) to assess skin barrier integrity at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)

    At 1 hour, the transepidermal water loss of both half faces will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier. This measure will be used to determine the effect of both products on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 1 hour of supervised application. The 1-hour measures of each half face will be compared with each other to compare the skin barrier integrity of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).

    Time frame: At 1 hour.

07

Study locations

1 site
  • Allergisa Pesquisa Dermato-Cosmetica Ltda
    Campinas, São Paulo 13084-791, Brazil
08

References and documents

Publications

  • Petrov A. Efficiency of Carbon Dioxide Fractional Laser in Skin Resurfacing. Open Access Maced J Med Sci. 2016 Jun 15;4(2):271-6. doi: 10.3889/oamjms.2016.062. Epub 2016 May 24. PubMed 27335599 ↗
  • Krupa Shankar D, Chakravarthi M, Shilpakar R. Carbon dioxide laser guidelines. J Cutan Aesthet Surg. 2009 Jul;2(2):72-80. doi: 10.4103/0974-2077.58519. PubMed 20808594 ↗
  • Zahr AS, Kononov T, Sensing W, Biron JA, Gold MH. An open-label, single-site study to evaluate the tolerability, safety, and efficacy of using a novel facial moisturizer for preparation and accelerated healing pre and post a single full-face radiofrequency microneedling treatment. J Cosmet Dermatol. 2019 Feb;18(1):94-106. doi: 10.1111/jocd.12817. Epub 2018 Nov 19. PubMed 30456804 ↗
  • ASSOCIAÇÃO MÉDICA MUNDIAL. Declaração de Helsinque. Princípios Éticos para Pesquisa Médica Envolvendo Participantes Humanos.Princípios Éticos para Pesquisa Médica Envolvendo Participantes Humanos.
  • BRASIL. Ministério da Saúde. RDC nº 466, de 12 de dezembro 2012. Aprova diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos.
  • Canfield Scientific. Visia CR: Facial Imaging System for Clinical Research. The Measuring Principle.
  • Courage + Khazaka electronic GmbH. Corneometer® CM 825. The Measuring Principle.
  • Courage + Khazaka electronic GmbH. Tewameter® TM 300. The Measuring Principle.
  • Courage + Khazaka electronic GmbH. Tewameter® TM Nano. The Measuring Principle.
  • International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.. ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001 Jan-Mar;47(1):45-50. No abstract available. PubMed 11590294 ↗
  • OPAS. Organização Pan-Americana de Saúde. Boas Práticas Clínicas: Documento das Américas. IV Conferência Pan-Americana para Harmonização da Regulamentação Farmacêutica, 2005.
  • WAMA Diagnóstica. Guia para o teste rápido de antígeno: Kit Imuno-Rápido COVID-19 Ag. 2021.

Individual participant data

Plan to share: Yes — Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Data sharing details ↗ · yoda.yale.edu

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2022 to primary completion in Apr 2022, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2022
First posted
Mar 9, 2022
StartActual
Mar 10, 2022
Primary completionActual
Apr 13, 2022
CompletionActual
Jun 16, 2022
Last update
Jun 29, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05272787
Responsible party
Sponsor
First posted
Mar 9, 2022
Start date
Mar 10, 2022
Primary completion
Apr 13, 2022
Completion
Jun 16, 2022
Last update
Jun 29, 2023

Study contacts

Mariane Martins Mosca, Bsc.
principal investigator · Allergisa Pesquisa Dermato-Cosmetica LTDA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion