A study to determine Efficacy of Lipstick and Kajal for Long Lasting Effect in Healthy Human Female Subjects
- Registration Number
- CTRI/2022/12/048122
- Lead Sponsor
- Renee Cosmetic Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
1)Age: 18 to 50 years (both inclusive) old at the time of consent.
2)Sex: Healthy human non-pregnant/non-lactating females.
3)Frequent user of lipstick and kajal.
4)Females of childbearing potential must have a self-reported negative urine pregnancy test on Day 01 before application and agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc.
5)Subjects are generally in good general health as determined from recent medical history.
6)The subject does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results.
7)The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits.
8)The subject must be able to understand and provide written informed consent to participate in the study
1)Subjects who are visually impaired or having underlying conditions that potentially impairs their vision.
2)Subject with eye makeup.
3)Subject who has applied any make-up on lips including moisturiser like Vaseline or lip balms.
4)Subjects with known history of allergies or specific allergic reactions upon using ophthalmic cosmetic products.
5)Subjects with presenting ophthalmic conditions like dry eye, cataract, conjunctivitis etc.
6)Subjects who are regular users of prescription or cosmetic contact lens.
7)Subjects who have dark circles under their eyes.
8)Subjects with Cleft lips or any other anatomical lip deformities.
9)Subjects who are reported pregnant/planning a pregnancy or lactating.
10)Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrollment.
11)Subjects, who in the opinion of the Investigator or the Expert Dermatologist are not eligible for enrollment in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To evaluate the long-lasting effect of the test product i.e. Renee Stay with me Matte Liquid Lip color (13 Shades) on lips using colorimeter. <br/ ><br>22.To evaluate the long-lasting effect of the test product i.e. RENEE hard black kajal pen using four-point scaleTimepoint: 1.from the baseline before product application and after product application at T0 (within 15 min of application), T8 hours, and T12 hours <br/ ><br>2. the baseline before product application and after product application at T0 (within 15 min of application), T8 hours, T12 hours and T24 hours
- Secondary Outcome Measures
Name Time Method