Status:
NOT_YET_RECRUITING
The Effect of Cosmetic Products on Skin Brightening
Lead Sponsor:
Unilever R&D
Collaborating Sponsors:
MS Clinical Research Pvt. Ltd
Conditions:
Skin Brightening
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
This is a single centre, single cell, blinded study designed to evaluate the effect of 5 cosmetic products on skin brightening, skin hydration and skin barrier function of the volar forearm after cont...
Detailed Description
This is a single centre, single cell, blinded study designed to evaluate the effect of cosmetic products on skin brightening, skin hydration and skin barrier function of the volar forearm after contro...
Eligibility Criteria
Inclusion
- Healthy female adult participants in general good health as determined from a recent medical history.
- Participants in the age group of 18-45 years as on the day of enrolment (both ages inclusive).
- Participants having very little hair, no burns, no cut/abrasion; no moles/tattoo/birth marks/burn marks on the test sites/areas as identified on screening.
- Participants with long and broad forearms.
- Participants having skin photo-type IV and V.
- Participants with Spectrophotometer L\* value- 45 to 55 (both values included) on the identified test sites on the volar forearm.
- Participants having uniform skin color and no sunburn/ erythema on the test sites.
- Participants who do not have very dry or scaly skin, uneven skin tone on their volar forearms or no other signs of significant local irritation or skin disease like psoriasis.
- Participants who agree to refrain from using pumice stone, scrubber while bathing during the study.
- Participants who are willing to avoid direct sun exposure to the test sites.
- Participants who have not participated in any clinical product evaluation test within past 1 month.
- Participants able to read and sign an appropriate informed consent form indicating her willingness to participate and agree to come for regular study visits.
- Participants willing to abide by and comply with the study protocol.
- Participants willing to use umbrella \& wear full covered attire if she has to go in sun.
- Participants who are willing not to participate in any other clinical study during participation in the current study.
Exclusion
- Participants with a known history or present condition of allergic response to any sunscreen products, cosmetic products, bathing soaps, detergent powder or medicine.
- Participants who have outdoor job, extremely physical (manual) job which could cause excessive sun exposure or sweating
- Participants who are smokers.
- Menopausal women.
- Participants having active skin diseases which will interfere with the test readings.
- Participants on oral and topical medications (e.g Steroids, anti-oxidant, antibiotics) which will compromise the study.
- Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy.
- Participants who are pregnant, lactating or nursing.
- Intense sun exposure/ photo allergenicity/toxicity.
- Chronic illness which may influence the cutaneous state.
- Participants participating in any other cosmetic or therapeutic trial.
- Participants with any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness that will pose a health risk due to study participation as per investigator's discretion.
- For female participants only: be pregnant, planning pregnancy or lactating/nursing. Urine pregnancy testing (UPT) will be performed at the time of screening.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06899321
Start Date
March 1 2025
End Date
May 1 2025
Last Update
March 27 2025
Active Locations (1)
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1
MS Clinical Research Pvt Ltd
Bangalore, Karnataka, India, 560008