EN22-0674-04 – Comparative evaluation of the Efficacy of two products in improving Diaper Rash in children - clinical and subjective study

Medcin Instituto da Pele Ltda0 个研究点开始时间: 2023年7月11日最近更新: 2023年7月26日

适应症

试验速览

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•Participants of both sexes; age between 3 months and 2 years and 11 months; diaper wearers; with irritant diaper dermatitis; with mild to moderate intertrigo, mild or clear erythema, without maceration, erosion or signs of infection in the area where the diaper is used; at least one parent or legal responsible willing to follow the trial procedures and attend the clinic on the days and times determined for applications and/or evaluations; at least one parent or legal responsible of the participants must understand, agree and sign the Informed Consent Form (TCLE)

•Participants and parents or legal responsible 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; atopic or allergic history to cosmetic products; 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 assessment; aesthetic or dermatological treatment up to 4 weeks before the evaluation; 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

发起方