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A clinical study to determine the efficacy of the test product for its Long Lasting Effect in Healthy Adult Human Female Subjects

A Proof-of-Concept, Efficacy Study of Midnight Kohl Pencil for Long Lasting Effect in Healthy Adult Human Female Subjects. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059370
Enrollment
32
Registered
2023-11-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

None listed

Interventions

Intervention1: Midnight Kohl Pencil: Frequency: Once a Day Route of Administration: Topical Duration: 24 hours Mode of Usage: Start with the inner corner of your eye and gently move outwards on your

Sponsors

Renee Cosmetics 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 kajal. 4.Females of childbearing potential must have a self-reported negative urine pregnancy test on Day 01 before application. 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.Subjects with known history of allergies or specific allergic reactions upon using ophthalmic cosmetic products. 4.Subjects with presenting ophthalmic conditions like dry eye, cataract, conjunctivitis etc. 5.Subjects who are regular users of prescription or cosmetic contact lens. 6.Subjects who have dark circles under their eyes. 7.Subjects who are reported pregnant/planning a pregnancy or lactating. 8.Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment. 9.Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.

Design outcomes

Primary

MeasureTime frame
1.To evaluate the long-lasting effect of the test productTimepoint: From baseline before product application and after product application at T0 (within 15 min of application), T8 hours, and T24 hours

Secondary

MeasureTime frame
1. To assess the effect of the test product for being smudge-freeTimepoint: from the baseline before product application and after product application at T0 (within 15 min of application), T8 hours, and T24 hours;2.To assess the safety of the test product at the periocular region in terms of eye irritation, redness, itchiness, and lachrymationTimepoint: From baseline before product application and after product application at T0 (within 15 min of application), T8 hours, and T24 hours;3.Change in photographs (Eye area)Timepoint: From baseline before product application and after product application at T0 (within 15 min of application), T8 hours, and T24 hours;4.To assess the effect of the test product in terms of product perception questionnaireTimepoint: From baseline before product application and after product application at T0 (within 15 min of application), T8 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