CTRI/2022/06/043046已完成未知
Evaluation of Skin Safety of a test product Minoxidil 10%w/v and Finasteride 0.1%w/vTopical Solution for Primary Skin Irritation Using Skin Irritation Test (Patch Test in Humans) IS 4011:2018 Guidelines.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 52
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
入选标准
- •1.Voluntary men and women between 18 and 60 years.
- •2.Photo type III to V.
- •Having apparently healthy skin on test area.
- •3.For whom the Investigator considers that the compliance will be correct.
- •4. Cooperating, informed of the need and duration of the examinations, and ready to comply
- •with protocol procedures.
- •5.Having signed a Consent Form.
- •6. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the
- •course of the study.
- •7. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.:
- •exercise, saunaâ?¦), during the course of the study.
- •8 Should be able to read and write (in English, Hindi or local language).
- •9. Having valid proof of identity and age.
排除标准
- •1. Pregnancy (by history) and lactating women.
- •2. Scars, excessive terminal hair or tattoo on the studied area.
- •3. Dermatological infection/pathology on the level of studied area.
- •4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
- •5.Any clinically significant systemic or cutaneous disease, which may interfere with study
- •procedures.
- •6. Chronic illness which may influence the outcome of the study.
- •7. Participants on any medical treatment either systemic or topical which may interfere with
- •the performance of the study (presently or in the past 1 month).
- •8. Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial
研究者
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