RBR-5cbvq6p尚未招募Unknown
EN22-0674-01_02_Allergenic evaluation for Cosmetic Product (HRIPT+Phototest)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
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; intact skin in the region of application; agreement to follow trial procedures and to report to the clinic on designated days and times for medical assessments and application and reading of pads; understanding, consent and signature of the Free and Informed Consent Term (TCLE); phototype: I, II, III and IV (for the phototest test, only phototypes II and III will be considered)
排除标准
- •For the HRIPT trial and phototest: Participants who have been diagnosed with COVID 19 within 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 evaluation or during the study period; anticipated intense exposure to sunlight or tanning sessions during the study period; prediction of sea bathing, 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 before 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 products (test or comparative product); history of non-compliance 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. Only for the phototest test: previous history of pathologies aggravated or triggered by ultraviolet radiation; use of photosensitizing drugs; history or activity of photodermatoses; personal or family history of skin cancer; presence of precursor lesions of skin cancer, such as melanocytic nevi and actinic keratoses; use of new drugs/cosmetics during the study
研究者
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