The Effect of Cosmetic Formulations on the Appearance of Grey Hair.

NCT07280676 | Recruiting

• 1 other identifier: HMN-BIO-4402
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hair Graying

Keywords

Hair appearance; Hair graying

Outcome Measures

Primary Outcomes (2)

• Visual assessment of percent gray hair

  Percent gray hair assessed over the whole head by expert assessor

  0 - 6 months

• Image analysis of appearance of gray hair

  Image analysis of global photographs of the head

  0 - 6 months

Secondary Outcomes (2)

• Image analysis of individual hair fibre color

  0 - 6 months

• Consumer perception of scalp and hair condition and hair grayness

  0 - 6 months

Other Outcomes (1)

• Proteomic analysis of scalp surface proteins associated with scalp and hair health

  0 - 6 months

Study Arms (2)

Cosmetic product U82

EXPERIMENTAL

Cosmetic scalp leave on product to be used once daily on the whole scalp for 6 months.

Other: U82

Cosmetic product Z63

EXPERIMENTAL

Cosmetic scalp leave on product to be used once daily on the whole scalp for 6 months.

Other: Z63

Interventions

U82 OTHER

Cosmetic scalp leave on product

Cosmetic product U82

Z63 OTHER

Cosmetic scalp leave on product

Cosmetic product Z63

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unilever R&D: lead
• Comprehensive Research Group, Inc.: collaborator

Study Sites (1)

Comprehensive Research Group, Inc.

Minneapolis, Minnesota, 55413, United States

RECRUITING

MeSH Terms

Interventions

RNA, U82 small nucleolar

Central Study Contacts

Sarah Paterson

CONTACT

+447775031771; sarah.paterson@unilever.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)