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A study to determine Efficacy of Lipstick and Kajal for Long Lasting Effect in Healthy Human Female Subjects

A Proof-of-Concept, Efficacy Study of Lipstick and Kajal for Long Lasting Effect in Healthy Human Female Subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048122
Enrollment
30
Registered
2022-12-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Renee Stay with me Matte Liquid Lip color (13 Shades): Mode of Usage: Starting from the centre of your upper lip, move towards the corner of your lip. Repeat the same with your bottom

Sponsors

Renee Cosmetic Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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. 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 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

MeasureTime frame
Change in photographTimepoint: From before product application and after product application at T0, T8, and T12 hours (lips and eyes), T24 hours post application (For Eye).;To assess the effect of the test product i.e RENEE hard black kajal pen for being smudge-free using four point scaleTimepoint: from the baseline before product application and after product application at T0 (within 15 min of application), T8 hours, T12 hours and T24 hours;To assess the effect of the test product i.e Renee Stay with me Matte Liquid Lip color (13 Shades) and RENEE hard black kajal pen in terms of product perception about long lasting effect, Matte finish & non cakey, not producing fine lines using Hedonic 9-point scale.Timepoint: After product application at T12 hours (for lipstick) and T24 hours (for Kajal);To assess the effect of the test product i.e. Renee Stay with me Matte Liquid Lip color (13 Shades)in terms of long-lasting effect, matte finish & non-cakey, hydration, is not producing fine lines using four point scale.Timepoint: from the baseline before application and after product application at T0 (within 15 min of application), T8 hours, and T12;To assess the non-transfer feature of the test product i.e Renee Stay with me Matte Liquid Lip color (13 Shades) after product application using Tissue paper testTimepoint: At T0 (within 15 min of application), T8 hours, and T12 hours;To assess the safety of the test product i.e RENEE hard black kajal pen at the periocular region in terms of eye irritation, redness, itchiness, and lacrimation using ophthalmologist scoring evaluation.Timepoint: from the baseline before product application and after product application at T0 (within 15 min of application), T8 hours, T12 hours and T24 hours

Countries

India

Contacts

Public ContactMaheshvari Patel

NovoBliss Research Private Limited

dr.nayan@novobliss.in9909013286

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026