The Effect of Cosmetic Products on Skin Brightening

NCT ID: NCT06899321

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2025-05-31

Brief Summary

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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

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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.

Conditions

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Skin Brightening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Each participant will receive all study products.

Study Groups

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Cosmetic product M68

Cosmetic product to be applied twice daily 6 days a week (except on measurement days, when it will be applied once) for the duration of the study.

Group Type EXPERIMENTAL

Cosmetic product M68

Intervention Type OTHER

Cosmetic skin brightening product to be applied to defined test site

Cosmetic product Z15

Cosmetic product to be applied twice daily 6 days a week (except on measurement days, when it will be applied once) for the duration of the study.

Group Type EXPERIMENTAL

Cosmetic product Z15

Intervention Type OTHER

Cosmetic skin brightening product to be applied to defined test site

Cosmetic product R52

Cosmetic product to be applied twice daily 6 days a week (except on measurement days, when it will be applied once) for the duration of the study.

Group Type EXPERIMENTAL

Cosmetic product R52

Intervention Type OTHER

Cosmetic skin brightening product to be applied to defined test site

Cosmetic product J61

Cosmetic product to be applied twice daily 6 days a week (except on measurement days, when it will be applied once) for the duration of the study.

Group Type EXPERIMENTAL

Cosmetic product J61

Intervention Type OTHER

Cosmetic skin brightening product to be applied to defined test site

Cosmetic product U36

Cosmetic product to be applied twice daily 6 days a week (except on measurement days, when it will be applied once) for the duration of the study.

Group Type EXPERIMENTAL

Cosmetic product U36

Intervention Type OTHER

Cosmetic skin brightening product to be applied to defined test site

No treatment control

No treatment control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cosmetic product M68

Cosmetic skin brightening product to be applied to defined test site

Intervention Type OTHER

Cosmetic product Z15

Cosmetic skin brightening product to be applied to defined test site

Intervention Type OTHER

Cosmetic product R52

Cosmetic skin brightening product to be applied to defined test site

Intervention Type OTHER

Cosmetic product J61

Cosmetic skin brightening product to be applied to defined test site

Intervention Type OTHER

Cosmetic product U36

Cosmetic skin brightening product to be applied to defined test site

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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MS Clinical Research Pvt. Ltd

UNKNOWN

Sponsor Role collaborator

Unilever R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MS Clinical Research Pvt Ltd

Bangalore, Karnataka, India

Site Status

Countries

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India

Central Contacts

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Dr Mukta Sachdev, MD

Role: CONTACT

+91 8040917243

Facility Contacts

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Dr Mukta Sachdev, MD

Role: primary

+91 80 40917243

Other Identifiers

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SKN-SKA-4328

Identifier Type: -

Identifier Source: org_study_id

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