Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Photosensitization Under Normal Conditions and When Exposed to Sunlight of a Scar Gel

Herbarium Laboratorio Botanico Ltda1 site in 1 country55 target enrollmentJanuary 13, 2025

ConditionsSensitivity, Contact Photosensitivity Phototoxicity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sensitivity, Contact
Sponsor: Herbarium Laboratorio Botanico Ltda
Enrollment: 55
Locations: 1
Primary Endpoint: Absence
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Evaluate the potential of Primary Dermal Irritability, Accumulated Dermal Irritability, Dermal Sensitization, Photoallergy and Photosensitization, of health products through the application of Patch Test, proving the safety of the product for topical use. The study will be conducted with a Brazilian sample in which 55 research participants will be included. Depending on the results, the present study may support the claim: dermatologically tested, non-irritating, non-sensitizing, non-photoirritating and non-photosensitizing.

Registry

clinicaltrials.gov

Start Date

January 13, 2025

End Date

February 20, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Herbarium Laboratorio Botanico Ltda

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants of both sexes aged 18 to 70 years;
•Phototypes: I, II, III, and IV (For the phototest trial, only phototypes II and III will be considered);
•Intact skin in the application area;
•Willingness to follow the trial procedures and attend the center on the specified dates and times for medical evaluations and for application and reading of dressings;
•Understanding, consent, and signing of the Informed Consent Form (ICF).

Exclusion Criteria

•Pregnancy or risk of pregnancy/lactation;
•Use of anti-inflammatory drugs within 30 days and/or immunosuppressive drugs up to three months before selection;
•Immunosuppression due to drugs or active diseases;
•Uncompensated endocrinopathies;
•Personal history of atopy;
•Intense sun exposure or tanning sessions up to 15 days before the evaluation or during the study period;
•Plans to bathe in the sea, pool, or sauna during the study;
•Practice of water sports during the study;
•Dermographism;
•Use of oral or topical treatments with vitamin A acid and/or its derivatives up to one month before the start of the study;

Outcomes

Primary Outcomes

Absence

Time Frame: 9 weeks

Absence of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Photosensitization under normal conditions and when exposed to sunlight.