Evaluation of dermatological safety and hypo-allergenicity of investigational products by HumanRepeat Insult Patch Test - HRIPT on healthy human volunteers as per IS 4011:2018 - HRIPT

Tricos Dermacologics Pvt Ltf0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月1日

试验速览

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•1.Voluntary men/women between 18 and 65 years.
•2.Photo type III to V.
•3.Self-declaration of subject with sensitive skin.
•4.Having apparently healthy skin on test area.
•5.For whom the investigator considers that the compliance will be correct.
•6.Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
•7.Having signed a Consent Form.
•8.Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
•9.Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna…), during the course of the study.
•10.Should be able to read and write (in English, Hindi or local language).
•11.Having valid proof of identity and age.

•1.Pregnant/nursing mothers
•2.Scars, excessive terminal hair or tattoo on the studied area.
•3.Henna tattoo anywhere on the body (in case of studies involving hair dyes).
•4.Dermatological infection/pathology on the level of studied area.
•5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye).
•6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
•7.Chronic illness which may influence the outcome of the study.
•8.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
•9.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.

发起方

Tricos Dermacologics Pvt Ltf