Diaper Rash
Conditions
Interventions
Single-center, single-blind, non-comparative clinical study to prove the safety in use of the investigational product. The experimental product is a clear barrier diaper rash treatment hydrogel. The r
Sponsors
Medcin Instituto da Pele Ltda
Megalabs Farmacêutica S.A.
Medcin Instituto da Pele Ltda
Eligibility
Age
No minimum to 3 Months
Inclusion criteria
Inclusion criteria: Participants of both sexes aged between 0 and 3 months; intact skin in the product analysis region; up-to-date vaccination card; be a user of cosmetic products of the same category; parents or legal representative willing to obey the trial procedures and be available for telephone contacts and/or via WhatsApp and telemarketing, with internet access on the days and times determined for the assessments; parents or legal representative who have a mobile device suitable for use and with access to the internet network for telephone contacts and/or via WhatsApp and call center, with internet access; parents or legal representative willing to attend the Clinical Research Center if necessary for evaluations; parents or legal representative of the participants must understand and agree with the Free and Informed Consent Term (TCLE) and consent to the participation of their child
Exclusion criteria
Exclusion criteria: Participants and parents or legal representative who have been diagnosed with COVID-19 in the last 4 weeks or who are experiencing symptoms such as fever, dry cough, tiredness, body aches or other discomforts; use of anti-inflammatory/ immunosuppressive/ antihistamine drugs up to 3 weeks before selection; 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); atopic or allergic history to cosmetic products; pathologies and/or active skin lesions (local and/or disseminated) in the assessment area; immunosuppression by drugs or active diseases; decompensated endocrinopathies; 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; children of 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 from participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the absence of risk of irritation and capture sensations of discomfort in the studied population, under dermatological and pediatric evaluation criteria. Safety dermatological and pediatric evaluations will be performed, via video call, at the initial (D0) and final (D21 ± 2 days) visit. After 3 weeks of using the product, the occurrence and intensity of erythema, edema, desquamation, vesiculation or other signs and/or clinical symptoms of adverse events will be evaluated, using a 04-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = intense). The results will be evaluated using the Wilcoxon test, comparing qualitative variables on an ordinal scale with a reference value of zero (absence of irritation). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected. | — |
Countries
Brazil
Contacts
Public ContactFlávia Addor
Medcin Instituto da Pele Ltda
Outcome results
None listed