Evaluation of Skin Safety of a test product using 24 Hours Patch Test Under Complete Occlusion on Adult Healthy Human Participants with Normal Skin. IS 4011:2018 Guidelines - NI

Dabur Research and Development Centre.0 sites26 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 23, 2023

Last Updated

2 years ago

Study Type

Interventional

Sponsor

Dabur Research and Development Centre.

•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.

•1\. Pregnancy (by UPT) 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).