Dermatological Assessment of Photoallergy and Phototoxicity

NCT04250623 | Completed

• 1 other identifier: All-S-FA-FT-SO-PAD-074832
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Sensitivity, Contact

Outcome Measures

Primary Outcomes (1)

• Absence

  Absence occurence of phototoxicity and photoallergy

  6 weeks

Study Arms (1)

subjects, 18-70 y, healthy

EXPERIMENTAL

subjects, 18-70 y, healthy

Other: Health care product (gel)

Interventions

Health care product (gel) OTHER

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

subjects, 18-70 y, healthy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Herbarium Laboratorio Botanico Ltda: lead

Study Sites (1)

Allergisa Pesquisa Dermato-Cosmética Ltda

Campinas, São Paulo, 13084-791, Brazil

Location

MeSH Terms

Conditions

Dermatitis, Contact

Interventions

Gels

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Clinical trial, single-arm

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 31, 2020
• Study Start: April 12, 2021
• Primary Completion: May 21, 2021
• Study Completion: May 21, 2021
• Last Updated: June 16, 2021

Record last verified: 2021-06

Locations

BR (1)