Pigment SpotsNCT06640244
The Effect of Cosmetic Face Care Products on Facial Skin Tone and Spot Brightening
A study testing Sunscreen, Cosmetic product G18 and Cosmetic product N70 in people with Pigment Spots, run by Unilever R&D at 1 site in India.
Trial summary
This is a single centre, 5-cell, blinded study to evaluate changes in even skin tone, skin glow, facial pigmented spots, and the microbiome of facial skin following the use of cosmetic face care products on the whole face over a 12 week period. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pigment Spots
- What is being tested?
- Sunscreen, Cosmetic product G18 and Cosmetic product N70
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteIndia
- Study dates
- 22 Oct 2024to 13 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female adult participants in general good health as determined from a recent medical history.
- Participants in the age group of 20-45 years (both ages inclusive).
- Participants having Fitzpatrick photo-type III-V.
- Participants with at least 3 spots on the cheek either of PIH post acne/age related
- Participants not presenting any skin condition that may interfere with the assessment for the entire study duration.
- Participants free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face
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- Participant who agrees not to use any other product/treatment/home remedy/serum on their face during the study period other than the study product.
- Participants who agree to remove all jewellery on/around face (e.g., necklace, earrings, nose ring), during imaging.
- Participants willing to give a voluntary written informed consent and photography release.
- Participants willing to abide by and comply with the study protocol.
- Participants able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
- Participants willing and capable to follow the study rules and a fixed schedule.
Who cannot join
- Participants who are currently participating in a similar study or have participated in a similar study in the past 6 weeks.
- Participants with any other signs of significant local irritation, erythema, or skin disease on skin.
- Participants having chronic illness or who have undergone major surgery in the last year that may be clinically relevant or can impact the results as determined by the dermatologist.
- Participants undergoing treatment for any skin condition.
- Participants allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else.
- Participants with self-perceived pimple prone and/or sensitive skin.
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- Participants taking any oral antibiotic medication currently or within the last 8 weeks.
- Participants taking medication continuously/regularly every day such as corticosteroids or non-steroidal anti-inflammatories, topically for four weeks or orally for eight weeks prior to the study.
- Female participant pregnant/breast feeding or planning pregnancy during the study period (self-declared)
- Participants taking product/treatment for any condition which the Investigator believes may influence the interpretation of the data.
- Participants currently taking any medication, which the investigator believes may influence the interpretation of the data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Efficacy of Prototypes for Improvement in Skin Tone and Spot Brightening in a Full-Face Study Design
This is a single centre, 5-cell, blinded study to evaluate changes in even skin tone, skin glow, facial pigmented spots, and the microbiome of facial skin following the use of cosmetic face care products on the whole face over a 12 week period.
Read the detailed description
This is a randomized, blinded, 5 cell, full-face study designed to evaluate changes in even skin tone, skin glow, pigmented spots and the surface microbiome of facial skin following the use of one of five cosmetic face care products. This study will accept up to 50 participants per cell (250 participants overall) who meet the inclusion/exclusion criteria to ensure that at least 40 participants per cell complete the study. Participants will be randomised to receive one of the five cosmetic face care products which will be applied to the whole face using a defined protocol.
If accepted onto the study, all participants will be provided with a marketed face wash to use for one week prior to the baseline visit and throughout the whole study.
Visual and instrumental assessments of skin colour, skin glow and even tone will be conducted throughout the duration of the study (12 weeks product use and 6 weeks regression). Non-invasive skin surface samples will be collected at several timepoints for evaluation of the skin microbiome.
- Conditions
- Pigment Spots
- Being tested
- Sunscreen, Cosmetic product G18, Cosmetic product N70, Cosmetic product D79, Cosmetic product E84
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunscreenOther
To be used by all participants throughout the study
Cosmetic product G18Other
Cosmetic face care product
Cosmetic product N70Other
Cosmetic face care product
Cosmetic product D79Other
Cosmetic face care product
Cosmetic product E84Other
Cosmetic face care product
Cosmetic product C68Other
Cosmetic face care product
| Study group | Role | What they receive |
|---|---|---|
| Cosmetic product G18 | Experimental | Cosmetic face care product to be used twice daily on the whole face for 12 weeks. Receives: Other: Sunscreen; Other: Cosmetic product G18 |
| Cosmetic product N70 | Experimental | Cosmetic face care product to be used twice daily on the whole face for 12 weeks. Receives: Other: Sunscreen; Other: Cosmetic product N70 |
| Cosmetic product D79 | Experimental | Cosmetic face care product to be used twice daily on the whole face for 12 weeks. Receives: Other: Sunscreen; Other: Cosmetic product D79 |
| Cosmetic product E84 | Experimental | Cosmetic face care product to be used twice daily on the whole face for 12 weeks. Receives: Other: Sunscreen; Other: Cosmetic product E84 |
| Cosmetic product C68 | Experimental | Cosmetic face care product to be used twice daily on the whole face for 12 weeks. Receives: Other: Sunscreen; Other: Cosmetic product C68 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual assessment of skin colour
Measured: 0-12 weeks + 6 weeks regression
Instrumental assessment of skin colour
Measured: 0-12 weeks + 6 weeks regression
Secondary outcomes (1)
Changes in skin surface microbiome
Measured: 0-12 weeks + 6 weeks regression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start22 Oct 2024
- Primary completion13 Nov 2025
- Study completion13 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigment SpotsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
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
- NCT06640244
- Sponsor's protocol ID
- HMN-SKA-4185
- Status last verified
- Nov 2025
- First submitted
- 10 Oct 2024
- Last updated
- 17 Nov 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Efficacy of Prototypes for Improvement in Skin Tone and Spot Brightening in a Full-Face Study Design
- ClinicalTrials.gov ID
- NCT06640244
- Acronym / sponsor ID
- HMN-SKA-4185
- Conditions
- Pigment Spots
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- MS Clinical Research Pvt. Ltd
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 15 Oct 2024 (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, 5-cell, blinded study to evaluate changes in even skin tone, skin glow, facial pigmented spots, and the microbiome of facial skin following the use of cosmetic face care products on the whole face over a 12 week period.
Detailed description
This is a randomized, blinded, 5 cell, full-face study designed to evaluate changes in even skin tone, skin glow, pigmented spots and the surface microbiome of facial skin following the use of one of five cosmetic face care products. This study will accept up to 50 participants per cell (250 participants overall) who meet the inclusion/exclusion criteria to ensure that at least 40 participants per cell complete the study. Participants will be randomised to receive one of the five cosmetic face care products which will be applied to the whole face using a defined protocol.
If accepted onto the study, all participants will be provided with a marketed face wash to use for one week prior to the baseline visit and throughout the whole study.
Visual and instrumental assessments of skin colour, skin glow and even tone will be conducted throughout the duration of the study (12 weeks product use and 6 weeks regression). Non-invasive skin surface samples will be collected at several timepoints for evaluation of the skin microbiome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cosmetic product G18 | Experimental | Other: Sunscreen, Other: Cosmetic product G18Cosmetic face care product to be used twice daily on the whole face for 12 weeks. |
| Cosmetic product N70 | Experimental | Other: Sunscreen, Other: Cosmetic product N70Cosmetic face care product to be used twice daily on the whole face for 12 weeks. |
| Cosmetic product D79 | Experimental | Other: Sunscreen, Other: Cosmetic product D79Cosmetic face care product to be used twice daily on the whole face for 12 weeks. |
| Cosmetic product E84 | Experimental | Other: Sunscreen, Other: Cosmetic product E84Cosmetic face care product to be used twice daily on the whole face for 12 weeks. |
| Cosmetic product C68 | Experimental | Other: Sunscreen, Other: Cosmetic product C68Cosmetic face care product to be used twice daily on the whole face for 12 weeks. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Female adult participants in general good health as determined from a recent medical history.
- Participants in the age group of 20-45 years (both ages inclusive).
- Participants having Fitzpatrick photo-type III-V.
- Participants with at least 3 spots on the cheek either of PIH post acne/age related
- Participants not presenting any skin condition that may interfere with the assessment for the entire study duration.
Key exclusion criteria (11 listed)
- Participants who are currently participating in a similar study or have participated in a similar study in the past 6 weeks.
- Participants with any other signs of significant local irritation, erythema, or skin disease on skin.
- Participants having chronic illness or who have undergone major surgery in the last year that may be clinically relevant or can impact the results as determined by the dermatologist.
- Participants undergoing treatment for any skin condition.
- Participants allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else.
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 |
|---|---|---|
| SunscreenTo be used by all participants throughout the study | Other | Cosmetic product C68, Cosmetic product D79, Cosmetic product E84, Cosmetic product G18, Cosmetic product N70 |
| Cosmetic product G18Cosmetic face care product | Other | Cosmetic product G18 |
| Cosmetic product N70Cosmetic face care product | Other | Cosmetic product N70 |
| Cosmetic product D79Cosmetic face care product | Other | Cosmetic product D79 |
| Cosmetic product E84Cosmetic face care product | Other | Cosmetic product E84 |
| Cosmetic product C68Cosmetic face care product | Other | Cosmetic product C68 |
Primary outcome
Visual assessment of skin colour
Time frame: 0-12 weeks + 6 weeks regression
Instrumental assessment of skin colour
Time frame: 0-12 weeks + 6 weeks regression
1 secondary outcome
Changes in skin surface microbiome
Time frame: 0-12 weeks + 6 weeks regression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunscreen, Cosmetic product G18 and Cosmetic product N70 in people with Pigment Spots, 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 12 inclusion and 11 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: finished, as of the sponsor's last update on 17 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual assessment of skin colour (time frame: 0-12 weeks + 6 weeks regression). The study lists 2 primary outcomes in all. 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 17 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.