Skin Irritation Test (Patch Test in Humans) IS 4011:2018 Guidelines.

PONTIKA AEROTECH LIMITED0 个研究点目标入组 26 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•1. Voluntary men and women (preferably equal number of males and females) between 18
•and 65 years.
•2. Photo type III to V.
•3. Having apparently healthy skin on test area.
•4. For whom the Investigator considers that the compliance will be correct.
•5. Cooperating, informed of the need and duration of the examinations, and ready to comply
•with protocol procedures.
•6. Having signed a Consent Form.
•7. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the
•course of the study.
•8. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.:
•exercise, sauna...), during the course of the study.
•9. Should be able to read and write (in English, Hindi or local language).
•10. Having valid proof of identity and age.

•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.

发起方

PONTIKA AEROTECH LIMITED