To evaluate the safety of investigational product by repeat use test for 14 days
- Registration Number
- CTRI/2019/07/020044
- Lead Sponsor
- ITC Life Sciences Technology Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1. Healthy non-pregnant/ non-lactating female subjects in the age group of 18-40 years (inclusive of both ages).
2. Females of childbearing potential must have a negative urine pregnancy test performed on screening visit.
3. Subjects willing to abide by the study protocol and restrictions.
4. Subjects with different skin types: normal, dry, oily and combination in nearly equal ratio.
5. About 20 Subjects who use contact lens for a period of 6-8 hrs daily.
6. Subjects with good general health as determined by the Investigator on the basis of medical history.
7. Subjects willing to give a voluntary written informed consent.
8. Subjects willing to use their own eye and lip make-up products, for the duration of the study.
9. Subjects having not participated in a similar investigation in the past two weeks.
10. Subjects willing to come for regular follow up visits.
11. Subjects ready to follow instructions during the study period.
1. Subject is either pregnant/ planning a pregnancy, or lactating.
2. Subject having known history or present condition of allergic response to any cosmetic products (face/eye)/ known or suspected intolerance to cosmetic ingredients including fragrance
3. Subject having any eye infection or allergy/ extremely sensitive eye condition.
4. Subject having any form of cutaneous disease which may influence the study result.
5. Previous history of atopy with regards to allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics or medication
6. Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational product and/or interfere with the evaluation of the test site reaction
7. Presence of open sores, pimples, or cysts at the application site
8. Subject having history of/or currently using medication (topical or systemic medications, oral or topical treatment with Vit. A and/or its derivatives, or allergy injections) which in the opinion of the investigator may affect the evaluation of the study product, or place the participant at undue risk.
9. Participation in another clinical study (including cosmetic/ drug studies) or studies with a similar application site, within 30 days of the screening visit.
10. Any participant who, in the judgment of the Investigator, should not participate in the study.
11. Any participant with corneal ulcers, keratoconus, blepharitis, meibomitis, pterygium, chemosis, moderately or severe hyperemia or other active ocular diseases.
12. Any participant having skin marks on their face that might interfere with the evaluation of possible skin reactions as per dermatologist.
13. An employee of the sponsor or the study site.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ophthalmological and dermatological safety assessment of productTimepoint: Ophthalmic and Dermatological assessment: Baseline, Week 1 and Week 2 (All post uses assessments will be done after 45±10 minutes)
- Secondary Outcome Measures
Name Time Method 1. Instant make up removal <br/ ><br>2. Removes water proof makeupTimepoint: Week 2 (Day 14) (All post uses assessments will be done after 45±10 minutes)