RBR-7jc7btr尚未招募Unknown
Assessment of primary dermal irritability, cumulative dermal irritability, and dermal sensitization (HRIPT)
Medicin Instituto da Pele Ltda0 个研究点开始时间: 2023年6月22日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18Y 至 70Y（—）
入选标准
- •Participants of both sexes aged 18 to 70* years; Phototype: I, II, III and IV (according to an adapted scale); Skin of the application region is intact; Agreeing to follow the trial procedures and attend the clinic on the days and times determined for medical evaluations and for applying and reading swabs; Understanding, consent and signature of the Free and Informed Consent Term
排除标准
- •Participants 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; Pregnancy or risk of pregnancy and/or lactation (when women); Use of anti-inflammatory drugs 30 days and/or immunosuppressants for up to three months before selection; Immunosuppression by drugs or active diseases; Decompensated endocrinopathies; Personal history of atopy; Intense sun exposure or tanning sessions up to 15 days before the assessment or during the study period; Expect intense exposure to sunlight or tanning sessions during the study period; Provision of bathing in the sea, swimming pool or sauna during the study; Practice of water sports during the study; Dermographism; Use of oral or topical treatment with vitamin A acid and/or its derivatives up to 1 week before the start of the study; Aesthetic and/or dermatological treatment on the body within 03 weeks prior to selection; Scheduled vaccination during the study period or up to 03 weeks before selection; History of sensitization, irritation or photosensitivity to topical products; Active skin pathologies (local and/or disseminated) that may interfere with the study results; Skin reactivity; Use of new drugs/cosmetics during the study; Previous participation in studies with the same product; Congenital or acquired immunodeficiency; Relevant medical history or current evidence of alcohol or other drug abuse; History of known or suspected intolerance to any ingredient of the study product (test or comparative product); History of non-adherence or unwillingness to adhere to the study protocol; 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. If yes, it should be described in observation in the clinical record
研究者
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