CTRI/2025/10/096537
Not yet recruiting
Phase 2
A clinical study to assess the efficacy of test products in improving biophysical properties of skin upon face cleansing.
Hindustan Unilever Limited1 site in 1 country96 target enrollmentStarted: November 7, 2025Last updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Hindustan Unilever Limited
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Improvement in Brightness, Hydration
Overview
Brief Summary
Volunteers are recruited based on inclusion and exclusion criteria and undergo 3 days of washout period. On Day 1 baseline (technical & dermatological) assessments are done. Volunteers and provided with face cleansers to apply on the face at the venue. There are 4 test groups in the study with different wash frequencies per day. Volunteers apply the product for 3 consecutive days and all assessments done post wash. All technical and dermatological visual assessments were compared vs baseline.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Healthy female volunteers 2)Volunteers with dull skin 3)Volunteers with dark spots 4)Volunteer in good health condition as per the medical screening criteria 5)Volunteer able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
- •Volunteers agreeing to comply with following study restrictions: 7)Willing to refrain from application of any other product/treatment on their face during wash off and treatment phase 8)Not to apply any cosmetic, skin care product or home remedies or any other face cleanser/wash/soap etc at home during the study period.
Exclusion Criteria
- •Volunteer pregnant or planning to become pregnant.
- •Volunteers who are breastfeeding or having stopped to breastfeed in the past three months.
- •Volunteers with any signs of significant local irritation, erythema or skin disease on scalp as well as on the visible parts of the body skin site.
- •Volunteers having chronic illness or had major surgery in the last year.
- •Volunteers undergoing any treatment of any skin condition on body.
- •Volunteers known to have allergies to cosmetics 7)Volunteers taking any food supplements.
Outcomes
Primary Outcomes
Improvement in Brightness, Hydration
Time Frame: Baseline, Day 1, Day 2, Day 3
Secondary Outcomes
- Safety assessments like redness and dryness(Baseline, Day 1, Day 2, Day 3)
Investigators
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.
Study Sites (1)
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