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Evaluation of efficacy and eye safety of test product

To evaluate in-vivo efficacy of eye make-up formulation in terms of long-lasting effect and ophthalmological safety of Color cosmetic on healthy female subjects of normal eye condition and contact lens users

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/043781
Enrollment
33
Registered
2022-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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: The Product is applied on lower eyelash. once in a day for period of 3 days. Control Intervention1: NIL: Not applicable

Sponsors

TTK HEALTHCARE LIMITED CONSUMER PRODUCT DIVISION
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Indian Female subjects 2. Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup) 3. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.) 4. Having varied eye conditions like normal and contact lens users. 5. Having habit of applying eye makeup i.e. kajal

Exclusion criteria

Exclusion criteria: 1. Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2. Having refused to give his/her assent by not signing the consent form 3. Taking part in another study liable to interfere with this study 4. Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 5. Having a progressive asthma (either under treatment or last fit in the last 2 years) 6. Being epileptic. 7. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8. Having cutaneous hypersensitivity 9. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 10. Following a chronic medicinal treatment comprising any of the following products: aspirin based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 11. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 12. Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit 13. Having applied a cosmetic product (included make-up) or skin care product on the studied areas the first day of the study (only face cleaned with water is accepted) 14. Refusing to follow the restrictions below during the study: Do not take part in any family planning activities leading to pregnancy and breastfeeding Do not take part in another study liable to interfere with this study Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). Do not change cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit. During the study: Do not use other eye related and/ or eye make up than the tested products to the studied areas. The day of the measurements: No test product or any other eye make up must be used 15. Having applied make-up products on eyes in the 48 hours preceding the start of the study. 16. Having permanent make-up on the studied area. 17. Having ocular problems (stye, chalazion, conjunctivitis). 18. Having applied an eye product and/or make up for eye, to the studied area the day of the measurements. 19. Do not itch the eyes 20. Do not use any eye drops or any eye treatment/ surgery during the study

Design outcomes

Primary

MeasureTime frame
Long Lasting effect of kajal, Opthalmological safetyTimepoint: 2 hours after product application, 4 hours after product application, 6 hours after product application, 8 hours after product application, 1day and 3 days

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactMr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

raji@mascotspincontrol.in02243349191

Outcome results

None listed

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