Evaluation of the skin safety of 1 soap, for skin irritation using a patch test.
- Registration Number
- CTRI/2017/08/009271
- Lead Sponsor
- VVF India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
•Voluntary men and/or women between 18 and 65 years.
•Having apparently healthy skin on test area.
•Willingness to discontinue the use of cleansing and/or cosmetic products in the treatment areas during the course of the study.
•Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
•Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, saunaâ?¦), during the course of the study.
•Ready to wear loose cotton clothes.
•Pregnant women and lactating women (by history).
•Scars, excessive terminal hair or tattoo on the studied area.
•Dermatological infection/pathology on the level of studied area.
•Hypersensitivity, allergy antecedent (to any cosmetic product, raw material).
•Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
•Participants 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patch Scoring (Erythema and oedema scoring)at 48 hours and 72 hoursTimepoint: Patch Scoring (Erythema and oedema scoring)at 48 hours and 72 hours
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable