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

GLOWDERMA LAB PVT LTD0 sites0 target enrollmentStarted: TBDLast updated: April 1, 2024

Trial Snapshot

No summary available.

•1.Voluntary men/women between 18 and 65 years.
•2.Photo type III to V.
•3.Self-declaration of subject with sensitive skin.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 excessive water contact (for example swimming) or activity which causes excessive sweating (that is 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.

•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.

Sponsor

GLOWDERMA LAB PVT LTD