EN22-0674-03_Evaluation of dermal and pediatric Acceptability for Cosmetic Product

Medcin Instituto da Pele Ltda0 个研究点开始时间: 2023年6月5日最近更新: 2023年6月26日

试验速览

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•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

•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

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