Safety checking of Product on eyes

Completed

• Conditions: having normal eye conditions & contact lens user, having habit of using face wash

• Registration Number: CTRI/2023/03/050979
• Lead Sponsor: DPKA UNIVERSAL CONSUMER VENTURES PRIVATE LIMITED

Brief Summary

OBJECTIVEThe objective of this study will be to evaluate Ophthalmologicalsafety of test product involving subjects of normal eye conditions &contact lens user on healthy female subjects coded:

Oil Balancing Cleanser (FR-010-19) :Product A

 Theevaluation is performed using:

Subject Self Evaluation (SSE)

Ophthalmological Evaluation: Safety

The study lasts 4 days following the firstapplication of the product.

 POPULATION33 female subjects *are selected for the study.*

The subjects selected for this study are healthy femalesubjects, aged between 18 to 40 years, having normal eye conditions &contact lens user, having habit of using face wash.

KineticsT0, T+30 minutes afterproduct application, T+1 day, T+3 days

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-24
• Study Completion: 2023-06-04
• Last Update Posted: 2023-06-11

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 33

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 & contact lens user, having habit of using face wash.

Exclusion Criteria

• 1Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
• 2Having refused to give her assent by not signing the consent form.
• 3Taking part in another study liable to interfere with this study.
• 4Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months).
• 5Having a progressive asthma (either under treatment or last fit in the last 2 years) 6Being epileptic.
• 7Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months).
• 8Having cutaneous hypersensitivity.
• 10Following 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).
• 11Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
• 12Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
• 13Having 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).
• 14Refusing 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) 15Having 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.
• 16Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp …) in the previous 2 weeks.
• 17Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) in the previous 1 month 18Having had beauty treatment (e.g. scrub, self-tanning product …) on the studied areas in the previous week.
• 19Having permanent make-up on the studied area.
• 20Having ocular problems (stye, chalazion, conjunctivitis).
• 21Having 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).
• 22Refusing 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, exfoliation, scrub, mask …).
• Do not itch the eyes.
• Do not wear lenses till the end of the study.
• Do not use any eye drops or any eye treatment/ surgery during the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ophthalmological safety	Baseline, 30 minutes, Day 1 and Day 3

Trial Locations

Locations (1)

Mascot Spincontrol India Pvt. Ltd.; 🇮🇳 Mumbai, MAHARASHTRA, India

Mascot Spincontrol India Pvt. Ltd.

🇮🇳Mumbai, MAHARASHTRA, India

Dr Raji Patil

Principal investigator

02243349191

raji@mascotspincontrol.in