Evaluation of an Investigational Product in the Restructuring of the skin protection barrier

Not Applicable

• Conditions: M01.774.500; Diaper Rash

• Registration Number: RBR-10brpqhz
• 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: 2023-06-09
• Last Update Posted: 26 June 2023
• Study Completion: 2023-07-25

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Participants of both sexes; aged between 18 and 60 years; intact skin in the region of the forearms; agreement to follow the trial procedures and to attend the clinic on the day and times determined for applications and/or evaluations; understand, consent and sign the informed consent form

Exclusion Criteria

Participants diagnosed with COVID-19 in the last 4 weeks or showing symptoms such as fever, dry cough, tiredness, body aches or other discomfort; pregnancy/lactation or intention to become pregnant during the study period; use of the following topical or systemic medications: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs, and corticosteroids up to 30 days before selection or considering immunosuppressants, the interval should be 3 months before selection; history of atopy and history of allergies to cosmetic products; pathologies and/or active skin lesions (local and/or disseminated) in the evaluation area; skin marks in the experimental area that interfere with the evaluation of possible skin reactions (vascular malformations, scars, increased hairiness, large amounts of nevus, sunburn); pathologies that cause suppression of immunity, such as diabetes, HIV, etc.; decompensated endocrinopathies; participants with known congenital or acquired immunodeficiency; relevant medical history or current evidence of alcohol or other drug abuse; known history of or suspected intolerance to products in the same category; intense sun exposure up to 15 days before the evaluation; aesthetic or dermatological treatment in the evaluation area up to 04 weeks before selection; professionals directly involved in performing this study; other conditions considered by the evaluating physician as reasonable for disqualification from participation in the study

Study & Design

• Study Type: Intervention
• Study Design: Not specified