CTRI/2022/01/039409已完成不适用
Evaluation of Skin Safety of a test product Minoxidil 10 percent weight by volume and FinasterideO.1 percent weight by volume Topical Solution for Primary Skin rrritation Using Skin Irritation Test (patchTest in Humans)IS 4011:2018 Guidelines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CIPLA LTD
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluation of cutaneous tolerance by dermatological scoring of skin reactions (erythema,
研究概览
简要总结
The test product, Minoxidil 10%w/v and Finasteride 0.1%w/v Topical Solution B.No: 1204-085 was dermatologically tested and found to be “Non-Irritant†based on IS 4011:2018,Methods of Test for safety evaluation of cosmetics -Third Revision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Voluntary men and women (preferably equal number of males and females) between 18 and 65 years.
- •Photo type III to V.
- •Having apparently healthy skin on test area.
- •For whom the Investigator considers that the compliance will be correct.
- •Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
- •Having signed a Consent Form.
- •Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
- •Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna...), during the course of the study.
- •Should be able to read and write (in English, Hindi or local language).
- •Having valid proof of identity and age.
排除标准
- •Pregnancy (by history) and lactating women.
- •Scars, excessive terminal hair or tattoo on the studied area.
- •Dermatological infection/pathology on the level of studied area.
- •Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
- •Any clinically significant systemic or cutaneous disease, which may interfere with study procedures.
- •Chronic illness which may influence the outcome of the study.
- •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).
- •Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial.
结局指标
主要结局
Evaluation of cutaneous tolerance by dermatological scoring of skin reactions (erythema,
时间窗: 48 hours
oedema, dryness, scaling wrinkling) using Draize scale
时间窗: 48 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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