Assessment of immediate and prolonged skin irritation and / or allergy.

Phase 1

Recruiting

• Conditions: Healthy Volunteers; M01.774.500

• Registration Number: RBR-72tgny
• Lead Sponsor: Medcin Instituto da Pele Ltda.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-07
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Age between 18 and 70 years; Phototypes I, II, III and IV as adapted Fitzpatrick scale Annex 1; Skin of the whole test region;

Exclusion Criteria

Gestation or risk of gestation and / or lactation when women; Use of anti-inflammatory drugs 30 days and / or immunosuppressants for up to three months prior to selection; Immunosuppression by drugs or active diseases;
Decompensated endocrinopathies; Personal history of atopy; Intense sun exposure or tanning sessions up to 15 days prior to evaluation or during the study period; Forecast of sea baths, swimming pool or sauna during the study; Practice water sports during the study; Dermographism; Use of oral or topical treatment with vitamin A acid and / or its derivatives up to 1 month before the start of the study; Aesthetic and / or dermatological treatment in the body within 03 weeks prior to selection; Scheduled vaccination during the study period or until 03 weeks prior to screening; History of sensitization and irritation to topical product; Active skin conditions (local and / or disseminated) that may interfere with the results of the study; Use of new drugs and / or cosmetics during the study; Skin reactivity; Previous participation in studies with the same product; Congenital or acquired immunodeficiency; Relevant clinical history or current evidence of alcohol or other drug abuse; Known or suspected intolerance of any ingredient in the study products test or comparative products; History of lack of adherence or unwillingness to adhere to the study protocol; Employees of Medcin or the sponsoring company involved in the study, or a close family member of an employee involved in the study. Other conditions considered by the researcher as reasonable for disqualification of study participation. If Yes, it should be described in observation in the clinical file;

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Check for the absence of irritation reactions (primary and accumulated dermal irritation) and allergy (dermal sensitization) of the investigational product in the population studied through the compatibility test.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are not expected.