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CompletedNCT03279159Updated Sep 12, 2017

Hydrating Efficacy and Tolerance Evaluation of a Face Cream

An interventional study of Jaluronius CS cream short term evaluation and Jaluronius CS cream long term evaluation in Dry and Damaged Skin, sponsored by Derming SRL. Completed at 1 site in Italy. Open to participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-12.

Sponsored by Derming SRL · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
45 Years to 60 Years
Sex
All
01

Study summary

Aim of the study was to evaluate by non-invasive instrumental evaluations tolerance and hydrating activity of a face topic product, to be applied twice a day, morning and evening, for an uninterrupted period of 8 weeks, by volunteers of both sexes, aged 45-60, who meet the inclusion and exclusion criteria required by the study procedure .

It was also aim of this study to evaluate the hydrating activity of a single product application on the skin damaged by repeated stripping corneum (short term evaluation versus untreated control area).

02

Conditions studied

  • Dry and Damaged Skin
03

Who can participate

Ages eligible
45 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • both sexes,
  • age 45-60 years,
  • caucasian subjects,
  • agreeing to present at each study visit without make-up,
  • accepting to follow the instructions received by the investigator,
  • accepting to not change their habits regarding food, physical activity, face cleansing and make- up use,
  • agreeing not to apply or take any product or use face massages or other means known to improve skin wrinkle and skin qualities during the entire duration of the study,
  • accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study,
  • no participation in a similar study currently or during the previous 3 months
  • accepting to sign the Informed consent form.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy (only for female subjects),
  • lactation (only for female subjects),
  • sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit),
  • subjects whose insufficient adhesion to the study protocol is foreseeable.
  • presence of cutaneous disease on the tested area as lesions, scars, malformations,
  • recurrent facial/labial herpes,
  • clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.).
  • endocrine disease,
  • hepatic disorder,
  • renal disorder,
  • cardiac disorder,
  • pulmonary disease,
  • cancer,
  • neurological or psychological disease,
  • inflammatory/immunosuppressive disease,
  • drug allergy.
  • anti-inflammatory drugs, anti-histaminic, topic (application on the face) and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of hormonal treatment starting more than 1 year ago),
  • using of drugs or dietary supplements able to influence the test results in the investigator opinion.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Jaluronius CS cream (Difa Cooper S.p.a, Italy)

    Other: Jaluronius CS cream short term evaluation · Other: Jaluronius CS cream long term evaluation

Interventions

  • OtherJaluronius CS cream short term evaluation

    Short term evaluation to investigate the hydrating activity of a single application of the study product on the forearms (volar surface) after repeated stripping procedure,measured immediately after stripping execution (T0i), 1,8 and 24 hour/s after product application (T1h, T8h and T24h).

  • OtherJaluronius CS cream long term evaluation

    Long term evaluation to investigate the hydrating activity of the repeated application of the study product on the face (twice a day, for an uninterrupted period of 8 weeks), measured at basal visit (T0) and after 4 and 8 week-treatment (T4, T8)

05

What researchers measure

Primary outcomes

  1. Change of superficial skin hydration after a single product application

    Variation of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany) after a single product application on the skin area damaged by corneum stripping

    Time frame: Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)

  2. Change of transepidermal water loss (TEWL) after a single product application

    Variation of transepidermal water loss value measured with Tewameter® TM300 (MPA 5 Courage-Khazaka, Germany) after a single product application on the skin area damaged by corneum stripping

    Time frame: Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)

  3. Change of superficial skin hydration after repeated product application

    Variation of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany) after repeated product application on the face

    Time frame: Baseline (T0), 4 weeks (T4), 8 weeks (T8)

  4. Change of deep skin hydration after repeated product application

    Variation of tissue dielectric constant value of deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland) after repeated product application on the face

    Time frame: Baseline (T0), 4 weeks (T4), 8 weeks (T8)

06

Study locations

1 site
  • DERMING
    Monza, Monza-brianza 20900, Italy
07

Registry details

Key details

Study ID
NCT03279159
Lead sponsor
Derming SRL
Responsible party
Adele Sparavigna (Dermatologist, Principal Investigator, Derming SRL) — Principal investigator
First posted
Sep 12, 2017
Start date
Mar 22, 2017
Primary completion
May 25, 2017
Completion
May 25, 2017
Last update
Sep 12, 2017

Oversight

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

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