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Assessment of Ophthalmological safety of skin care product

To evaluate Ophthalmological safety of test product involving subjects of normal eye conditions on healthy female subjects. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059530
Enrollment
33
Registered
2023-11-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

None listed

Interventions

Intervention1: Face cleanser: The whole face to be washed with the test product. The face to be washed twice in a day for the period of 4 days. Control Intervention1: Nil: NA

Sponsors

DPKA UNIVERSAL CONSUMER VENTURES PRIVATE LIMITED
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)Between 18 and 40 years of age. 4)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 5)Subjects having normal eye conditions.

Exclusion criteria

Exclusion criteria: 1 Being pregnant or breastfeeding or having stopped to breastfeed in the past three months. 2 Having refused to give 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. (only test cleanser is accepted) - The day of the measurements: No test product or any other eye make up must be used (only face cleaned with water is accepted) 15 Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, A.H.A….) in the 2 weeks preceding the start of the study. 16 Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp …) in the previous 2 weeks. 17 Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) in the previous 1 month 18 Having had beauty treatment (e.g. scrub, self-tanning product …) on the studied areas in the previous week. 19 Having permanent make-up on the studied area. 20 Having ocular problems (stye, chalazion, conjunctivitis). 21 Having applied a cosmetic eye product (included eye make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted). 22 Refusing to follow the restrictions below during the study: - Do not start, change or stop a hormonal treatment (hormonal contraception, cyproterone acetate …). - Do not have beauty treatment (e.g. skin cleansing,

Design outcomes

Primary

MeasureTime frame
Ophthalmological safetyTimepoint: Baseline, 30 minutes, Day 1 and Day 3

Secondary

MeasureTime frame
NilTimepoint: NA

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

investigators@mascotspincontrol.in02243349191

Outcome results

None listed

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