Skin BrighteningNCT06899321
The Effect of Cosmetic Products on Skin Brightening
A study testing Cosmetic product M68, Cosmetic product Z15 and Cosmetic product R52 in people with Skin Brightening, run by Unilever R&D at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Brightening
- What is being tested?
- Cosmetic product M68, Cosmetic product Z15 and Cosmetic product R52
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2025to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
MS Clinical Research Pvt Ltd
Bangalore, Karnataka, 560008
Dr Mukta Sachdev, MD, +91 80 40917243, mukta.sachdev@msclinical.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Skin Brightening
- Being tested
- Cosmetic product M68, Cosmetic product Z15, Cosmetic product R52, Cosmetic product J61, Cosmetic product U36
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic product M68Other
Cosmetic skin brightening product to be applied to defined test site
Cosmetic product Z15Other
Cosmetic skin brightening product to be applied to defined test site
Cosmetic product R52Other
Cosmetic skin brightening product to be applied to defined test site
Cosmetic product J61Other
Cosmetic skin brightening product to be applied to defined test site
Cosmetic product U36Other
Cosmetic skin brightening product to be applied to defined test site
| Study group | Role | What they receive |
|---|---|---|
| Cosmetic product M68 | Experimental | 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. Receives: Other: Cosmetic product M68 |
| Cosmetic product Z15 | Experimental | 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. Receives: Other: Cosmetic product Z15 |
| Cosmetic product R52 | Experimental | 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. Receives: Other: Cosmetic product R52 |
| Cosmetic product J61 | Experimental | 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. Receives: Other: Cosmetic product J61 |
| Cosmetic product U36 | Experimental | 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. Receives: Other: Cosmetic product U36 |
| No treatment control | No intervention | No treatment control |
What is being measured
The primary outcome is the main question the study is designed to answer.
L* measured using CM2600D
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
Measured: 0 - 6 weeks
Secondary outcomes (3)
a* measured using CM2600D
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
Measured: 0 - 6 weeks
Skin hydration measured using Corneometer CM825
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
Measured: 0 - 6 weeks
Skin barrier function (Trans-Epidermal Water Loss [TEWL]) measured using Tewameter TM300
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
Measured: 0 - 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin BrighteningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MS Clinical Research Pvt. Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899321
- Sponsor's protocol ID
- SKN-SKA-4328
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate Test Products for Skin Brightening Benefit Under Controlled UV Exposure, in a 6-week Study Design
- ClinicalTrials.gov ID
- NCT06899321
- Acronym / sponsor ID
- SKN-SKA-4328
- Conditions
- Skin Brightening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- MS Clinical Research Pvt. Ltd
- Study start
- Mar 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cosmetic product M68 | Experimental | Other: Cosmetic product M68Cosmetic 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. |
| Cosmetic product Z15 | Experimental | Other: Cosmetic product Z15Cosmetic 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. |
| Cosmetic product R52 | Experimental | Other: Cosmetic product R52Cosmetic 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. |
| Cosmetic product J61 | Experimental | Other: Cosmetic product J61Cosmetic 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. |
| Cosmetic product U36 | Experimental | Other: Cosmetic product U36Cosmetic 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. |
| No treatment control | No intervention | –No treatment control |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosmetic product M68Cosmetic skin brightening product to be applied to defined test site | Other | Cosmetic product M68 |
| Cosmetic product Z15Cosmetic skin brightening product to be applied to defined test site | Other | Cosmetic product Z15 |
| Cosmetic product R52Cosmetic skin brightening product to be applied to defined test site | Other | Cosmetic product R52 |
| Cosmetic product J61Cosmetic skin brightening product to be applied to defined test site | Other | Cosmetic product J61 |
| Cosmetic product U36Cosmetic skin brightening product to be applied to defined test site | Other | Cosmetic product U36 |
Primary outcome
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
3 secondary outcomes
a* measured using CM2600D
Time frame: 0 - 6 weeks
Skin hydration measured using Corneometer CM825
Time frame: 0 - 6 weeks
Skin barrier function (Trans-Epidermal Water Loss [TEWL]) measured using Tewameter TM300
Time frame: 0 - 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Skin Brightening
Not yet recruiting
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
Active, not recruiting
An Exploratory Study to Evaluate Skin Brightening Effects of Different Cosmetic Formulations on UV Irradiated Tanning Model
Skin Brightening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cosmetic product M68, Cosmetic product Z15 and Cosmetic product R52 in people with Skin Brightening, run by Unilever R&D at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Mukta Sachdev, MD (+91 8040917243, mukta.sachdev@msclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
L* measured using CM2600D (time frame: 0 - 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.