Evaluation of Skin Safety of a test product for Primary Skin Irritation Using Skin Irritation Test (Patch Test in Humans) IS 4011:2018 Guidelines.

Mosaic Wellness Private Limited0 个研究点目标入组 26 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•1. Voluntary men and women (preferably equal number of males and females) between 18
•and 65 years.
•2. Fitzpatrick skin type III to IV.
•3. Having apparently healthy skin on test area.
•4. Willingness to discontinue the use of cleansing and/or cosmetic products in the application
•areas during the course of the trial
•5. Cooperating, informed of the need and duration of the examinations, and ready to comply
•with protocol procedures.
•6. Willing to give written informed consent to participate in the trial after informing all
•information concerning the trial procedures and trial objectives.
•7. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the
•course of the trial.
•8. Willingness to avoid water contact (swimming) or activity which cause sweating (exercise, saunaÃ¢â?¬Â¦), during the course of the trial.
•9. Should be able to read and write (in English, Hindi, or local language).

•1.Pregnancy (by history) and lactating women.
•2.Scars, excessive terminal hair, or tattoo on the studied area.
•3. A participant who the Investigator feels will not be compliant with trial requirements
•4.Dermatological infection/pathology on the level of studied area.
•5. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
•6. Any clinically significant systemic or cutaneous disease, which may interfere with trial
•procedures.
•7. Chronic illness which may influence the outcome of the trial.
•8. 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).
•9. Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial.

发起方