To assess primary skin irritation as per BIS Directives with new cosmetic samples.
- Registration Number
- CTRI/2019/09/021117
- Lead Sponsor
- Godrej Consumer Care Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Volunteer (Male / Female) between 18 to 65 years old
2.Phototype III to V
3.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 excessive water contact(for example: swimming) or activity which causes excessive sweating(i.e., exercise, sauna), during the course of the study.
8.Should be able to read and write (i.e., in English, Hindi and Local Language).
9.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 the study treatment or procedures.
7.Chronic illness which may influence the outcome of the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method