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A study to evaluate the safety of test product by repeat use test in healthy female subjects.

A Study To Evaluate The Safety Of Test Product By Repeat Use Test (14 Days) In Healthy Female Subjects Of Varied Eye Conditions (Normal Condition And Contact Lens Users) and Varied Skin Conditions(Normal, Dry, Oily, Combination, Sensitive).

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019145
Enrollment
35
Registered
2019-05-15
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Skin leave on-Batch no-CDNCC-A: A grape sized amount of the product should be dispensed onto clean palms and gently applied all over the face including the forehead, eye area (upper and

Sponsors

ITC Life Sciences Technology Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Women subjects in the age group of 18 to 40 (inclusive of both ages) 2.Subjects willing to abide by the study protocol and restrictions. 3.Subjects with the specified eye condition as per the study requirement: normal and contact lens users in nearly equal ratio (1:1) Normal condition: Subjects who are not sensitive to eye cosmetic products such as Kajal, Eye pencil, Eyeliner, Eye shadows and Mascara etc. Contact lens users: Subjects who use soft contact lens for a period of 6 to 8 hours a day. The contact lens used by the subjects could either be daily disposable or monthly disposable contact lens. 4.Subjects with the specified skin type: normal, dry, oily, combination and sensitive in nearly equal ratio (1:1:1:1:1).

Exclusion criteria

Exclusion criteria: 1.Women subjects who are pregnant or lactating 2.A known history or present condition of allergic response to any cosmetic products (eye/ facial cosmetic products). 3.Subjects having eye infection or allergy. 4.Subjects having extremely sensitive eye condition. 5.Subjects having any form cutaneous disease which may influence the study result.

Design outcomes

Primary

MeasureTime frame
Evaluation of Ophthalmologic and Dermal safety of the test products in causing no ocular irritation or dermal irritation on repeated use involving subjects of varied eye conditions such as normal condition and contact lens users.Timepoint: 14 Days

Secondary

MeasureTime frame
Evaluation of the post use skin sensorials and product efficacy in removing color cosmeticsTimepoint: 14 Days

Countries

India

Contacts

Public ContactDr Sapna R

MS Clinical Research Pvt Ltd

sapna.r@mscr.in08041125934

Outcome results

None listed

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