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clinical study to determine the effectiveness of test product for Long-Lasting, Waterproof, and Smudge-Proof Results in Healthy Adult Human Female Participants

A clinical safety and efficacy study of Kajal for Long-Lasting, Waterproof, and Smudge-Proof Results in Healthy Adult Human Female Subjects - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/02/081184
Enrollment
32
Registered
2025-02-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

None listed

Interventions

Intervention1: Kajal: Dose: required amount Dosage Form: Kajal Pencil Route of Administration: Topical Mode of Usage: Start applying at the inner corner of the eye and gently glide the outward along

Sponsors

Maxima Solutions
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 18 years and above old at the time of consent. 2. Sex: Healthy human non-pregnant/non-lactating females. 3. Frequent | Daily user of Kajal. 4. Females of childbearing potential must have a self-reported negative urine pregnancy test on Day 01 before application. 5. Females who are using contact Lenses (2 to 5 female participants). 6. Subjects are generally in good general health as determined from recent medical history. 7. The subject does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results. 8. The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits. 9. 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 have dark circles under their eyes. 6. Subjects who are reported pregnant/planning a pregnancy or lactating. 7. Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment. 8. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of the test product in terms of 1. change in long lasting effect 2. being water proof and smudge-Proof 3. Eye irritation, redness, itchiness, and lachrymation 4. Change in photograph 5. subjective questionnaireTimepoint: baseline before product application and after product application at T0 (within 10 mins) hours, T24 hours, and T36 hours of application

Secondary

MeasureTime frame
Not applicableTimepoint: Not applicable

Countries

India

Contacts

Public ContactMaheshvari Patel

NovoBliss Research Private Limited

dr.nayan@novobliss.in09909013286

Outcome results

None listed

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