CTRI/2021/11/038298已完成不适用
Evaluation of Skin Safety of a test product for Primary Skin Irritation Using Skin Irritation Test (Patch Test in Humans) IS 4011:2018 Guidelines.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Evaluation of cutaneous tolerance of skin reactions (erythema, oedema, dryness, scaling
研究概览
简要总结
The test product, Be Bodywise 1% Ketoconazole Dandruff Shampoo-B. No: BKS-01
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.
- •Fitzpatrick skin type III to IV.
- •Having apparently healthy skin on test area.
- •Willingness to discontinue the use of cleansing and/or cosmetic products in the application areas during the course of the trial
- •Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
- •Willing to give written informed consent to participate in the trial after informing all information concerning the trial procedures and trial objectives.
- •Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the trial.
- •Willingness to avoid water contact (swimming) or activity which cause sweating (exercise, sauna…), during the course of the trial.
- •Should be able to read and write (in English, Hindi, or local language).
排除标准
- •1.Pregnancy (by history) and lactating women.
- •2.Scars, excessive terminal hair, or tattoo on the studied area.
- •A participant who the Investigator feels will not be compliant with trial requirements 4.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 trial procedures.
- •Participants on any medical treatment either systemic or topical which may interfere with the performance of the trial (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 of skin reactions (erythema, oedema, dryness, scaling
时间窗: 48 hours
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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