RBR-8sv755终止1 期
Evaluation Of The Primary And Accumulated Dermal Irritation Potential And Sensitization Of An Investigational Product - ID27568
INFAN - Indústria Química e Farmacêutica Nacional0 个研究点开始时间: 2020年6月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 70Y（—）
入选标准
- •Participants of both sexes; Age between 18 to 70 years; Phototypes: I, II, III and IV (according to an adapted Fitzpatrick scale - Annex 1); Skin of the whole test region; Agreement to obey the trial procedures and attend the clinic on the days and times
- •determined for medical evaluations and for application and reading of the dressings; Understand, consent and sign the Free
- •and Informed Consent Form (ICF).
排除标准
- •Pregnancy or risk of pregnancy and / or lactation; (when women); Background atopic or allergic to health products; Use of anti-inflammatory drugs 30 days and / or immunosuppressive for up to three months before selection; Diseases that cause suppression of immunity, such as diabetes and HIV; Personal history of atopy; Intense sun exposure or tanning sessions up to 15 days before the evaluation; Prediction of intense exposure to sunlight or tanning sessions during the study period; Prediction of sea baths, pool or sauna during the study; Water sports practice during the study; Dermographism (property that has the skin of certain individuals to swell and redden in the place where it is streaked by something
- •relatively sharp); Use of oral or topical treatment with vitamin A acid and / or its derivatives up to 1 month before the beginning of the study; Aesthetic and / or dermatological treatment on the body within 03 weeks before selection; Vaccination scheduled during the study period or up to 03 weeks before selection; History of sensitization and irritation to a topical product; Active skin pathologies (local and / or disseminated) that may interfere with the results of the study; Use of new drugs, health products that
- •are not part of the participant's routine during
- •the study; Skin reactivity; Previous participation in studies with the
- •same product; Known history or suspected intolerance
- •to any ingredient in the study products (test or comparative products); History of lack of adherence or unwillingness to adhere to the study protocol; Other conditions considered by the
- •evaluating physician as reasonable for the disqualification from participation in the study.
研究者
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