Two leave-on cosmetic products for improving the appearance of gray hair
The Effect of Cosmetic Formulations on the Appearance of Gray Hair
This 6-month study will try two leave-on cosmetic hair products to see if they improve the appearance of gray hair in adults with 15–35% natural graying.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 25 Years to 60 Years |
| Sex | All |
| Sponsor | Unilever R&D Industry-sponsored |
| Drugs / interventions | belimumab, chemotherapy, radiation, methotrexate, cyclophosphamide, prednisone |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT07280676 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized, double-blind whole-head study will compare two leave-on cosmetic hair formulations applied to the scalp according to a defined protocol over 180 days. Up to 380 participants (190 per product arm) will be enrolled to ensure at least 150 completers per arm. Visual and instrumental measurements of hair color will be collected throughout the study, and non-invasive skin surface samples will be taken at baseline, day 90, and day 180 for targeted and untargeted proteomic analysis. Marketed shampoo and conditioner products will be provided for use during the study period.
Who should consider this trial
Good fit: Adults aged 25–60 with 15–35% naturally gray hair who can read English and are available for all study visits are ideal candidates.
Not a fit: People with less than 15% or more than 35% gray hair, or those with underlying medical conditions affecting hair color (or who were excluded for other medical reasons), are less likely to benefit from these cosmetic formulations.
Why it matters
Potential benefit: If successful, the products could make gray hair look less noticeable or improve overall hair color appearance without medical procedures.
How similar studies have performed: Smaller cosmetic studies have reported modest improvements in hair appearance with topical formulations, but long-term repigmentation outcomes remain largely unproven in large randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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) * 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.
Where this trial is running
Minneapolis, Minnesota
- Comprehensive Research Group, Inc. — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Sarah Paterson
- Email: sarah.paterson@unilever.com
- Phone: +447775031771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.