A study for Under eye dark circles
- Registration Number
- CTRI/2022/09/045732
- Lead Sponsor
- Transformative Learning Solutions Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
1.Female adult subjects in general good health as determined from a recent medical history.
2.Subjects in the age group of 30-55 years (both ages inclusive).
3.Subjects having periorbital Melanosis/ under eye dark- circle on grade 2 or more as per MSCR photo numerical scale (Refer Appendix-2)
4.Subject having eye puffiness in under eye area on grade 2 or more as per MSCR photo numerical scale (Refer Appendix-2)
5.Subject should be willing to abstain from other under eye treatment during the study period.
6.Subjects willing to give a voluntary written informed consent and agree to come for regular follow up.
7.Subject agreeable for photography.
8.Subjects willing to abide by and comply with the study protocol.
9.Subjects who have not participated in a similar investigation in the past two weeks.
10.Subjects who are willing not to participate in any other clinical study during participation in the current study
1.A known history or present condition of allergic response to any cosmetic products.
2.Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.
3.Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy.
4.Subjects having eye infection or allergy as per medical history.
5.Subjects having extremely sensitive eye condition.
6.Subjects having eye disorders like cataract, conjunctivitis, etc. as per medical history
7.Subjects who are pregnant, lactating or nursing.
8.Intense sun exposure/ photo allergen city/toxicity.
9.Chronic illness which may influence the cutaneous state.
10.Subject participating in any other cosmetic or therapeutic trial.
11.Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Visible reduction in appearance of Dark Circles <br/ ><br>2. Visible reduction in appearance of fine lines & wrinkles / Crowâ??s feet wrinkles <br/ ><br>3. Reduces Puffiness eyes <br/ ><br>4. Imparts moisturization <br/ ><br>5. Reduces droopy/saggy eyesTimepoint: Day 0, Day 28, Day 42 and Day 56
- Secondary Outcome Measures
Name Time Method The product safety profile by dermatologist and ophthalmologistTimepoint: Day 0, Day 28, Day 42 and Day 56