Exposure to UV rays and dermatological verification of the appearance of allergies and / or irritations.

Phase 1

Recruiting

• Conditions: Healthy volunteers; M01.774.500

• Registration Number: RBR-59759n
• 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: 2019-07-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

Participants of both sexes; Age between 18 and 70 years; Phototypes: II or III according to the adapted scale Fitzpatrick Appendix 1; Skin of the intact test region;

Exclusion Criteria

Pregnancy or risk of gestation, lactation when women; Prediction of bathing by sea, pool or bath during the study; Water sports practice during the study; Historical Personal of Atopy; History of sensitization or photosensitization to topical products; Previous history of pathologies worsened or triggered by ultraviolet radiation; Use of anti-inflammatory drugs up to 30 days before selection or immunosuppressants up to 03 months before; Immunosuppression by drugs or active diseases; Endocrinopatias descompensadas; Use of fotossensibilizantes drugs; Active cutaneous pathologies that may interfere with the results of the studies; History or activity of photodermatoses; Dermografismo; Personal or family history of skin cancer; Presence of precursor lesions of cutaneous neoplasia, such as melanocytic nevi and Actinic keratoses; Intense solar exposure in the test area; Use of new medications, cosmetics during the study; participation before in a study with the same product; Relevant clinical history or current evidence of alcohol or other drug abuse; Use of oral or topical treatment with vitamin A acid and or its derivatives up to 1 month before the beginning of the study; Known history or suspicion of intolerance to any ingredient in the study products,test or comparative products; Aesthetic and or dermatological treatment in the body within 03 weeks before selection; Scheduled vaccination during the study period or up to 03 weeks before selection; Other conditions considered by the researcher as reasonable for disqualification of the participation of the study. If yes, it should be described under observation in the clinical form; Employees of Medcin or the sponsoring company involved in the study, or close family member of an employee involved in the study; History of lack of adherence or lack of willingness to adhere to the study protocol.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected to demonstrate the absence of irritant potential of the product applied to the skin and using the method of exposure to ultraviolet radiation to perform the reading of scale as recommended by the International Contact Dermatitis Research Group (ICDRG).

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are not expected.