Diaper Rash
Conditions
Interventions
Single-blind, comparative clinical study. The experimental product is a clear barrier diaper rash treatment hydrogel. The participants will not know what the product is, having access only to the prod
Sponsors
Medcin Instituto da Pele Ltda
Megalabs Farmacêutica S.A.
Medcin Instituto da Pele Ltda
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of the investigational product in the restructuring of the skin barrier after the process of cutaneous disruption by tape stripping. The evaluations will be performed immediately after the tape stripping and before the application of the investigational product, and 15, 30, 120 and 240 minutes after a single application of the product, through measurements by the Tewameter equipment. The results will be evaluated to verify if there is a difference between the experimental times. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected. | — |
Countries
Brazil
Contacts
Public ContactFlávia Addor
Medcin Instituto da Pele Ltda
Outcome results
None listed