Dermatological Assessment of Photoallergy and Phototoxicity

Dermatological Assessment of Photoallergy and Phototoxicity Under Controlled and Maximised Conditions.

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

Study Overview

• Status: Completed
• Conditions: Sensitivity, Contact
• Intervention / Treatment: Other: Health care product (gel)

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Campinas, SP, Brazil, 13084-791
      • Allergisa Pesquisa Dermato-Cosmetica Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: subjects, 18-70 y, healthy	Other: Health care product (gel); hyaluronic acid intimate moisturizing gel (to be applied on the subject's skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence	Absence occurence of phototoxicity and photoallergy	6 weeks

Collaborators and Investigators

• Sponsor: Herbarium Laboratorio Botanico Ltda

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 12, 2021
• Primary Completion (ACTUAL): May 21, 2021
• Study Completion (ACTUAL): May 21, 2021

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (ACTUAL): January 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 12, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis, Irritant; Photosensitivity Disorders; Dermatitis, Allergic Contact; Dermatitis, Contact; Dermatitis, Phototoxic; Dermatitis, Photoallergic
• Other Study ID Numbers: All-S-FA-FT-SO-PAD-074832

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No