Clinical trial NCT06899321: The Effect of Cosmetic Products on Skin Brightening
Official title: A Clinical Study to Evaluate Test Products for Skin Brightening Benefit Under Controlled UV Exposure, in a 6-week Study Design
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Skin Brightening
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: MS Clinical Research Pvt. Ltd
First posted: 2025-03-27
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 controlled UV exposure as compared to baseline and a no-treatment control.

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 controlled UV exposure. This study will accept 34 participants who meet the inclusion and exclusion criteria. Participants will test all 5 products and a no-treatment control, which will be applied twice daily for 6 weeks to pre-defined test sites on their volar forearms.

UV exposure will be conducted using a SOL UV solar simulator (300 - 1200nm; dose level 6 joules/cm2) at various time points during weeks 2 - 5 of the study.

Instrumental assessments of skin brightening, skin hydration and skin barrier function will be conducted at regular intervals throughout the whole study. Non-invasive samples of the stratum corneum will be collected at several timepoints during the study to evaluate biomarkers of skin brightening.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: L* measured using CM2600D
timeFrame: 0 - 6 weeks
Secondary outcomes:
measure: a* measured using CM2600D
timeFrame: 0 - 6 weeks
measure: Skin hydration measured using Corneometer CM825
timeFrame: 0 - 6 weeks
measure: Skin barrier function (Trans-Epidermal Water Loss [TEWL]) measured using Tewameter TM300
timeFrame: 0 - 6 weeks
Other outcomes:
measure: Stratum corneum biomarkers of skin brightening
timeFrame: 0 - 6 weeks
Locations:
city: Bangalore
country: India
facility: MS Clinical Research Pvt Ltd
state: Karnataka
Study officials:
References: