The Effect of Cosmetic Products on Skin Brightening

March 20, 2025 updated by: Unilever R&D

A Clinical Study to Evaluate Test Products for Skin Brightening Benefit Under Controlled UV Exposure, in a 6-week Study Design

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: No treatment control
Experimental: 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.
Other: Cosmetic product M68
Cosmetic skin brightening product to be applied to defined test site
Experimental: 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.
Other: Cosmetic product Z15
Cosmetic skin brightening product to be applied to defined test site
Experimental: 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.
Other: Cosmetic product R52
Cosmetic skin brightening product to be applied to defined test site
Experimental: 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.
Other: Cosmetic product J61
Cosmetic skin brightening product to be applied to defined test site
Experimental: 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.
Other: Cosmetic product U36
Cosmetic skin brightening product to be applied to defined test site

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
L* measured using CM2600D
Time Frame: 0 - 6 weeks

L* (Luminance) - represents lightness/darkness values of luminosity indices (total quantity of light reflected). L* is measured using spectrophotometer CM2600D, which measures the spectral reflectance in the visible wavelength range of 400nm to 700nm as the ratio of the power of the net total reflected light over total incident light. The colour values of L*a*b* are calculated from the spectral reflectance.

  • Manufacturer Name: Konica Minolta
  • Measurement Range: L* 0 - 100
  • Efficacy Direction of L*: Higher is better
0 - 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
a* measured using CM2600D
Time Frame: 0 - 6 weeks

a* (Red/green component of CIELAB colour space). a* represents colour ranging from red to green - positive values are red; negative values are green.

a* is measured using a spectrophotometer CM2600D, which measures the spectral reflectance in the visible wavelength range of 400nm to 700nm as the ratio of the power of the net total reflected light over total incident light. The colour values of L*a*b* are calculated from the spectral reflectance.

  • Manufacturer Name: Konica Minolta
  • Measurement Range: a* -128 to 127
  • Efficacy Direction of a*: +a is redder, -a is greener
0 - 6 weeks
Skin hydration measured using Corneometer CM825
Time Frame: 0 - 6 weeks

The corneometer (CM825) indirectly measures the skin's hydration as a change in capacitance of the stratum corneum.

  • Manufacturer Name: MPA (Multiprobe Adaptor) unit from C&K (Courage & Khazaka)
  • Depth of measurement approximately 45 μm
  • Measurement Range: 0 - 120 Arbitrary Units (AU)
  • Efficacy Direction of Corneometer reading: Higher is better
0 - 6 weeks
Skin barrier function (Trans-Epidermal Water Loss [TEWL]) measured using Tewameter TM300
Time Frame: 0 - 6 weeks

Skin barrier function (TEWL) is measured using the Tewameter TM300.

  • Manufacturer Name: MPA (Multiprobe Adaptor) unit from C&K (Courage Khazaka)
  • Measurement Range: 0 - 250 g/m²/h
  • Efficacy Direction of TEWL reading: Lower is better
0 - 6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stratum corneum biomarkers of skin brightening
Time Frame: 0 - 6 weeks

Biomarkers associated with skin brightening will be measured from non-invasive D-Squame tape-strip samples of the stratum corneum.

Up to 15 sequential tape strips will be collected.

The following biomarkers will be analysed using ELISA:

Filaggrin: measure of skin barrier. ng/ml. Efficacy: higher is better. IL1a: measure of inflammation. pg/ml. Efficacy: lower is better. IL1RA: measure of inflammation. pg/ml. Efficacy: lower is better. Catalase: measure of antioxidant effect. pg/ml. Efficacy: higher is better. Total antioxidant. mmol/L. Efficacy: higher is better.

Total protein will also be measured.

Additional biomarkers related to the objectives may also be measured.
0 - 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unilever R&D

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
MS Clinical Research Pvt. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SKN-SKA-4328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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