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

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.

Study Overview

• Status: Recruiting
• Conditions: Hair Graying
• Intervention / Treatment: Other: U82; Other: Z63

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 Type: Interventional
• Enrollment (Estimated): 380
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Paterson; Phone Number: +447775031771; Email: sarah.paterson@unilever.com

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55413
      • Recruiting
      • Comprehensive Research Group, Inc.
      • Contact: Tracey Baubie; Phone Number: +1-612-781-3400; Email: tbaubie@crginc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cosmetic product U82; Cosmetic scalp leave on product to be used once daily on the whole scalp for 6 months.	Other: U82; Cosmetic scalp leave on product
Experimental: Cosmetic product Z63; Cosmetic scalp leave on product to be used once daily on the whole scalp for 6 months.	Other: Z63; Cosmetic scalp leave on product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image analysis of individual hair fibre color	Image analysis of macro photographs of selected areas of the scalp	0 - 6 months
Consumer perception of scalp and hair condition and hair grayness	Questionnaires	0 - 6 months

Other Outcome Measures

Outcome Measure	Time Frame
Proteomic analysis of scalp surface proteins associated with scalp and hair health	0 - 6 months

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: Comprehensive Research Group, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hair graying; Hair appearance
• Additional Relevant MeSH Terms: RNA, U82 small nucleolar
• Other Study ID Numbers: HMN-BIO-4402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No