Safety study of cosmetics as per BIS.
- Registration Number
- CTRI/2021/02/031056
- Lead Sponsor
- Godrej Consumer Products Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Phototype III to V.
Healthy skin on test area.
having signed a consent form
able to read and write
valid id prrof.
urine test negative for women.
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. Subjects in an exclusion period or participating in another food or cosmetic or therapeutic trial.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of skin irritation potential ( Occurence of Erythema and Oedema ) w.r.t. Investigational Products at 4th day.Timepoint: at 4th day.
- Secondary Outcome Measures
Name Time Method To Check Contact Hypersensitivity as per BIS 4011 : 2018 directivesTimepoint: at 4th day.