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CompletedNCT04250623Updated Jun 16, 2021

Dermatological Assessment of Photoallergy and Phototoxicity

An interventional study of Health care product (gel) in Sensitivity, Contact, sponsored by Herbarium Laboratorio Botanico Ltda. Completed at 1 site in Brazil. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-16.

Sponsored by Herbarium Laboratorio Botanico Ltda · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This is a clinical study for health care product safety assessment. The research will be conducted with 40 subjects*, aged 18 to 70 years. The product will be applied on the right and/or left participant back for 3 consecutive weeks. After 10 days, will have another application of the same product, which will be removed in 24 hours. Medical evaluation will be available throughout the study to assess possible adverse events.

The objective of the study is to observe the effects of the application of the product on the skin and prove the absence of photoallergy and phototoxicity.

* 29 completed the trial

Read the detailed description

40 subjects, aged 18 to 70 years, phototypes II to III (according to Fitzpatrick classification). The patch test will be used to verify the absence of photoallergy and phototoxicity by the investigational products. The products will be applied twice a week for 3 consecutive weeks, as they are over semi-occlusive dressings. The product will remain in contact with the skin for 24 hours, after product removal the area will be irradiated with ultraviolet lamp A and B (UVA/UVB). Then, the procedure will be repeated after 10 days of wash out.

02

Conditions studied

  • Sensitivity, Contact
03

In context

Dermatitis, Phototoxic

22 studies on the registry are indexed under Dermatitis, Phototoxic; 1 is open to participants now.

This study's enrollment of 29 is below the median of 35 across 19 interventional studies indexed under Dermatitis, Phototoxic.

Browse Dermatitis, Phototoxic studies →

Lead sponsor

Herbarium Laboratorio Botanico Ltda is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Agreement to comply with safety guidelines to minimize the risk of contamination to COVID-19;
  • Agreement to perform a molecular test for the detection of COVID-19 to enter the study;
  • Healthy participants;
  • Non-injured skin in the test region;
  • Agreement to adhere to the test procedures and requirements and to attend the institute on the day(s) and at the time(s) determined for the evaluations;
  • Ability to consent to participation in the study;
  • Age from 18 to 70 years;
  • Phototype (Fitzpatrick): II and III;
  • Any gender

Exclusion criteria

Exclusion Criteria:

  • Participants who belong to the risk group for COVID-19, that is, with diabetes, with chronic cardiovascular, renal and respiratory problems, immunosuppressed or other conditions that the physician deems as belonging to the risk group;
  • Skin marks in the experimental area;
  • Active dermatoses (local or widespread);
  • Pregnant or breastfeeding women;
  • History of allergic reactions, irritation or intense feelings of discomfort to topical products;
  • History of phototoxic or photoallergic reactions;
  • History of allergy to materials used in the study;
  • History of atopy;
  • Personal or family pathological history of skin cancer;
  • History of pathologies aggravated or triggered by ultraviolet radiation;
  • Carriers of immunodeficiencies;
  • Intense sun exposure or tanning session up to 15 days before the initial evaluation;
  • Predicted intense sun exposure or tanning session during the course of the study;
  • Predicted bathing in the sea, pool or bathtub during the study;
  • Participants who practice water sports;
  • Dermography;
  • Use of the following topical or systemic drugs: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs and corticoids up to 2 weeks prior to selection or, considering deposit corticoids, the interval shall be 1 month prior to selection;
  • Use of topical or systemic photosensitizing drugs;
  • Treatment with acid vitamin A and/or its derivatives via oral or topical until 1 month before the beginning of the study;
  • Aesthetic and/or body dermatological treatment until 3 weeks before selection;
  • Vaccination during the study or until 3 weeks before the study;
  • Being or having participated in another clinical trial terminated less than 7 days before selection, in case the previous trial is acceptable in use;
  • Being or having participated in another clinical trial terminated less than 21 days ago, in case the previous trial is compatible or Adverse Reaction investigative;
  • History of absence of adherence or unwillingness to adhere to the study protocol;
  • Professionals directly involved in the execution of this protocol and their relatives.
  • Participants who have COVID-19, or who present symptoms indicative of the disease in the last 14 days.
  • Any condition not mentioned above that, in the opinion of the investigator, may compromise the evaluation of the study.
05

Study design

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

Study arms

  • Experimental
    subjects, 18-70 y, healthy

    subjects, 18-70 y, healthy

    Other: Health care product (gel)

Interventions

  • OtherHealth care product (gel)

    hyaluronic acid intimate moisturizing gel (to be applied on the subject's skin)

06

What researchers measure

Primary outcomes

  1. Absence

    Absence occurence of phototoxicity and photoallergy

    Time frame: 6 weeks

07

Study locations

1 site
  • Allergisa Pesquisa Dermato-Cosmética Ltda
    Campinas, SP 13084-791, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04250623
Lead sponsor
Herbarium Laboratorio Botanico Ltda
Responsible party
Sponsor
First posted
Jan 31, 2020
Start date
Apr 12, 2021
Primary completion
May 21, 2021
Completion
May 21, 2021
Last update
Jun 16, 2021

Oversight

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

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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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