Skin Safety study on Healthy Human Subjects of all types Ski
- Registration Number
- CTRI/2019/05/019100
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy female subjects in the age group of 18-65 years (both age inclusive).
2.Subjects with normal, dry, oily, combination and sensitive skin (preferably in equal ratio).
3.Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumannâ??s skin type questionnaire to qualify as sensitive skin.
4.Subjects with normal Fitzpatrick skin type III to V.
5.Subjects free from excessive hair, cuts, wounds, irritation symptoms, abrasion or any other skin condition which may interfere in the study results.
6.Subjects willing to give a voluntary written informed consent.
7.Subjects willing to maintain the patch test in position for 24 hours.
8.Subject having not participated in a similar investigation in the past two weeks.
9.Subjects willing to come for regular follow up visits.
•Subjects ready to follow instructions during the study period
1.Infection, allergy on the tested area.
2.Skin allergy antecedents or atopic subjects.
3.Subjects with known hypersensitivity to any of the study products or constituents.
4.Subjects with any significant skin pathology in the investigational area
5.Athletes and subjects with history of excessive sweating.
6.Cutaneous disease which may influence the study result.
7.Subjects using any topical or systemic treatment that could interfere with the study treatments/assessments within the last 4 weeks prior to participation in the study and during the study.
8.Subjects on oral corticosteroid.
9.Subjects participating in any other cosmetic or therapeutic study.
10.Female subjects who are pregnant or lactating.
11.Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method