A study to evaluate the safety of test product by repeat use test in healthy female subjects.
- Registration Number
- CTRI/2019/05/019145
- Lead Sponsor
- ITC Life Sciences Technology Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
1.Women subjects in the age group of 18 to 40 (inclusive of both ages)
2.Subjects willing to abide by the study protocol and restrictions.
3.Subjects with the specified eye condition as per the study requirement: normal and contact lens users in nearly equal ratio (1:1)
Normal condition: Subjects who are not sensitive to eye cosmetic products such as Kajal, Eye pencil, Eyeliner, Eye shadows and Mascara etc.
Contact lens users: Subjects who use soft contact lens for a period of 6 to 8 hours a day. The contact lens used by the subjects could either be daily disposable or monthly disposable contact lens.
4.Subjects with the specified skin type: normal, dry, oily, combination and sensitive in nearly equal ratio (1:1:1:1:1).
1.Women subjects who are pregnant or lactating
2.A known history or present condition of allergic response to any cosmetic products (eye/ facial cosmetic products).
3.Subjects having eye infection or allergy.
4.Subjects having extremely sensitive eye condition.
5.Subjects having any form cutaneous disease which may influence the study result.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of Ophthalmologic and Dermal safety of the test products in causing no ocular irritation or dermal irritation on repeated use involving subjects of varied eye conditions such as normal condition and contact lens users.Timepoint: 14 Days
- Secondary Outcome Measures
Name Time Method Evaluation of the post use skin sensorials and product efficacy in removing color cosmeticsTimepoint: 14 Days