Hair GrayingNCT07280676
The Effect of Cosmetic Formulations on the Appearance of Grey Hair.
A study testing U82 and Z63 in people with Hair Graying, run by Unilever R&D at 1 site in United States.
Trial summary
This study is a 6-month (180 days) single-center, double blind study designed to explore the effect of two cosmetic products on the appearance of gray hair. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Hair Graying
- What is being tested?
- U82 and Z63
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to Dec 2026
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy Female or Male between the ages of 25 and 60 years old, both inclusive at the time of consent.
- Of any race and ethnicity.
- Able to read and understand all study instructions and any other relevant study documents and understand the test procedures (in English) and able to provide a free decision about participating in the study.
- Has 15 - 35% naturally gray hair
- Available to come to all study visits.
Who cannot join
- Individuals with any relevant past or present medical history which may affect the study results or may lead to increased risk to the participant in the judgement of the Investigator or designee, including a history of cancer, insulin-dependent diabetes, acute or chronic renal insufficiency, chronic inflammatory disorders (arthritis, osteoarthritis, inflammatory bowel disease, colitis, etc.), asthma (not including exercise-induced asthma), epilepsy, uncontrolled hyperthyroidism, or uncontrolled hypothyroidism. Participants who have well controlled hyperthyroidism and hypothyroidism (stable medication for greater than 6 months) will be permitted.
- Pattern hair loss (Savin ≥ 2 for females, or Hamilton-Norwood ≥IV \& excluding vertex hair loss for males) or any history of hair loss for medical reasons, including, but not limited to, alopecia areata, alopecia universalis, alopecia totalis or telogen effluvium.
- Individuals that are sensitive/allergic to any of the ingredients in any of the test products adhesives, tattoo pigments/ink, or metals used in needles (i.e., chromium or nickel).
- Individuals with an immunological disorder or bloodborne disease (e.g. HIV, HBC, AIDS, multiple sclerosis, Crohn's disease, rheumatoid arthritis) or currently using oral or systemic immunosuppressive medications and biologics (e.g., azathioprine, belimumab, Cimzia®, Cosentyx®, cyclophosphamide, cyclosporine, Enbrel®, Humira®, Imuran®, Kineret®, mycophenolate mofetil, methotrexate, Orencia®, prednisone, Remicade®, Rituxan®, Siliq™, Simponi®, Stelara®, Taltz®) and/or undergoing radiation or chemotherapy as determined by study documentation.
- Individuals having started a long-term medication within the last 6 months or have changed brand, manufacture, or dosage of a long-term medication.
- Individuals currently using or having regularly used corticosteroids (known as steroids), systemically or topically, topically anywhere on the body, except nasal, and/or ocular use is acceptable within the past 4 weeks (including but not limited to betamethasone, clobetasol, desoximetasone, diflorasone, fluocinonide, fluticasone, mometasone, halcinonide, and halobetasol) (see list in Appendix 8)
Show all 12Show fewer
- Individuals currently taking any other medications which, in the opinion of the Investigator or designee, may interfere with the study (e.g. prescription anti-inflammatory drugs, anticoagulants, etc.).
- Individuals with hemophilia, anemia, or any other blood clotting disorder.
- Individuals who have a history of systemic granulomatous diseases, active or inactive, (e.g., sarcoidosis, Wegener's granulomatosis, tuberculosis) or connective tissue diseases (e.g., lupus, dermatomyositis).
- Individuals who are involved in any aspect of administration or an employee of Sponsor or testing facility.
- Individuals currently used/taking or have used/taken within the last 3 months any topical or ingestible anti-gray hair or hair growth supplements/treatments (examples: Arey: Not Today, Anti-gray hair supplements, Heyhair: Gray Escape Advanced Anti-Gray Hair Growth Supplements, Vegamour: GRO Ageless Gray Delay Hair Supplements, Elon Essentials, R3 Extra Strength etc.).
- The Investigator may exclude participants for other conditions, factors, or medications that they believe may affect the response of the skin or the interpretation of the test results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Comprehensive Research Group, Inc.
Minneapolis, Minnesota, 55413
Tracey Baubie, +1-612-781-3400, tbaubie@crginc.org
About this study
Official title: The Effect of Cosmetic Formulations on the Appearance of Gray Hair
This study is a 6-month (180 days) single-center, double blind study designed to explore the effect of two cosmetic products on the appearance of gray hair.
Read the detailed description
This is a randomised, double blind, whole head study designed to evaluate the effect of two cosmetic leave on treatments on the appearance of gray hair. This study will accept up to 190 participants per cell (380 participants overall) who meet the inclusion/exclusion criteria to ensure that at least 150 participants per cell complete the study. Participants will be randomised to receive one of the two cosmetic hair products. The products will be applied to the whole scalp using a defined protocol.
If accepted onto the study, participants will be provided with marketed shampoo and conditioner products for use throughout the study.
Visual and instrumental assessments of hair color will be conducted throughout the duration of the study (6 months/180 days). Non-invasive skin surface samples will be collected at baseline, day 90 and day 180 for evaluation of target proteins and untargeted proteomic analysis of scalp and hair health.
- Conditions
- Hair Graying
- Being tested
- U82, Z63
- Keywords
- Hair appearance, Hair graying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U82Other
Cosmetic scalp leave on product
Z63Other
Cosmetic scalp leave on product
| Study group | Role | What they receive |
|---|---|---|
| Cosmetic product U82 | Experimental | Cosmetic scalp leave on product to be used once daily on the whole scalp for 6 months. Receives: Other: U82 |
| Cosmetic product Z63 | Experimental | Cosmetic scalp leave on product to be used once daily on the whole scalp for 6 months. Receives: Other: Z63 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual assessment of percent gray hair
Percent gray hair assessed over the whole head by expert assessor
Measured: 0 - 6 months
Image analysis of appearance of gray hair
Image analysis of global photographs of the head
Measured: 0 - 6 months
Secondary outcomes (2)
Image analysis of individual hair fibre color
Image analysis of macro photographs of selected areas of the scalp
Measured: 0 - 6 months
Consumer perception of scalp and hair condition and hair grayness
Questionnaires
Measured: 0 - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start15 Dec 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair GrayingStudies 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
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Comprehensive Research Group, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280676
- Sponsor's protocol ID
- HMN-BIO-4402
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2025
- Last updated
- 30 Apr 2026
- Results posted
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cosmetic Formulations on the Appearance of Gray Hair
- ClinicalTrials.gov ID
- NCT07280676
- Acronym / sponsor ID
- HMN-BIO-4402
- Conditions
- Hair Graying
- Keywords
- Hair appearance, Hair graying
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Comprehensive Research Group, Inc.
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Dec 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 study is a 6-month (180 days) single-center, double blind study designed to explore the effect of two cosmetic products on the appearance of gray hair.
Detailed description
This is a randomised, double blind, whole head study designed to evaluate the effect of two cosmetic leave on treatments on the appearance of gray hair. This study will accept up to 190 participants per cell (380 participants overall) who meet the inclusion/exclusion criteria to ensure that at least 150 participants per cell complete the study. Participants will be randomised to receive one of the two cosmetic hair products. The products will be applied to the whole scalp using a defined protocol.
If accepted onto the study, participants will be provided with marketed shampoo and conditioner products for use throughout the study.
Visual and instrumental assessments of hair color will be conducted throughout the duration of the study (6 months/180 days). Non-invasive skin surface samples will be collected at baseline, day 90 and day 180 for evaluation of target proteins and untargeted proteomic analysis of scalp and hair health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cosmetic product U82 | Experimental | Other: U82Cosmetic scalp leave on product to be used once daily on the whole scalp for 6 months. |
| Cosmetic product Z63 | Experimental | Other: Z63Cosmetic scalp leave on product to be used once daily on the whole scalp for 6 months. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Female or Male between the ages of 25 and 60 years old, both inclusive at the time of consent.
- Of any race and ethnicity.
- Able to read and understand all study instructions and any other relevant study documents and understand the test procedures (in English) and able to provide a free decision about participating in the study.
- Has 15 - 35% naturally gray hair
- Available to come to all study visits.
Key exclusion criteria (12 listed)
- Individuals with any relevant past or present medical history which may affect the study results or may lead to increased risk to the participant in the judgement of the Investigator or designee, including a history of cancer, insulin-dependent diabetes, acute or chronic renal insufficiency, chronic inflammatory disorders (arthritis, osteoarthritis, inflammatory bowel disease, colitis, etc.), asthma (not including exercise-induced asthma), epilepsy, uncontrolled hyperthyroidism, or uncontrolled hypothyroidism. Participants who have well controlled hyperthyroidism and hypothyroidism (stable medication for greater than 6 months) will be permitted.
- Pattern hair loss (Savin ≥ 2 for females, or Hamilton-Norwood ≥IV \& excluding vertex hair loss for males) or any history of hair loss for medical reasons, including, but not limited to, alopecia areata, alopecia universalis, alopecia totalis or telogen effluvium.
- Individuals that are sensitive/allergic to any of the ingredients in any of the test products adhesives, tattoo pigments/ink, or metals used in needles (i.e., chromium or nickel).
- Individuals with an immunological disorder or bloodborne disease (e.g. HIV, HBC, AIDS, multiple sclerosis, Crohn's disease, rheumatoid arthritis) or currently using oral or systemic immunosuppressive medications and biologics (e.g., azathioprine, belimumab, Cimzia®, Cosentyx®, cyclophosphamide, cyclosporine, Enbrel®, Humira®, Imuran®, Kineret®, mycophenolate mofetil, methotrexate, Orencia®, prednisone, Remicade®, Rituxan®, Siliq™, Simponi®, Stelara®, Taltz®) and/or undergoing radiation or chemotherapy as determined by study documentation.
- Individuals having started a long-term medication within the last 6 months or have changed brand, manufacture, or dosage of a long-term medication.
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 |
|---|---|---|
| U82Cosmetic scalp leave on product | Other | Cosmetic product U82 |
| Z63Cosmetic scalp leave on product | Other | Cosmetic product Z63 |
Primary outcome
Visual assessment of percent gray hair
Time frame: 0 - 6 months
Percent gray hair assessed over the whole head by expert assessor
Image analysis of appearance of gray hair
Time frame: 0 - 6 months
Image analysis of global photographs of the head
2 secondary outcomes
Image analysis of individual hair fibre color
Time frame: 0 - 6 months
Consumer perception of scalp and hair condition and hair grayness
Time frame: 0 - 6 months
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 30 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Hair Graying
Not yet recruitingPhase 3
Clinical Study of CS-001 as a Treatment for Canities (Grey Hair)
Canities, Grey Hair
Not yet recruitingPhase 1/2
Clinical Study of mTOR Inhibitor as a Treatment for Grey Hair (Canities)
Canities, Grey Hair
Not yet recruiting
A Clinical Trial to Investigate the Efficacy of BioCopper1®, Restore Cu1, and Grow + Restore Cu1 on Hair and Skin Improvements in Healthy Adults
Grey Hair, Hair Growth
Recruiting
6-Month Trial of Chinese Herbal Treatments for Hair Loss and Gray Hair
Alopecia, Canities
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 U82 and Z63 in people with Hair Graying, run by Unilever R&D at 1 site in United States.
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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. 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 United States. 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 Sarah Paterson (+447775031771, sarah.paterson@unilever.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual assessment of percent gray hair (time frame: 0 - 6 months). 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 30 Apr 2026.