The Effect of Cosmetic Formulations on the Appearance of Gray Hair
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 380
- Locations
- 2
- Primary Endpoint
- Visual assessment of percent gray hair
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Statistician
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Cosmetic product U82
Cosmetic scalp leave on product to be used once daily on the whole scalp for 6 months.
Intervention: U82 (Other)
Cosmetic product Z63
Cosmetic scalp leave on product to be used once daily on the whole scalp for 6 months.
Intervention: Z63 (Other)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Consumer perception of scalp and hair condition and hair grayness(0 - 6 months)
- Image analysis of individual hair fibre color(0 - 6 months)
- Consumer perception of scalp and hair condition and hair grayness(0 - 6 months)
- Image analysis of individual hair fibre color(0 - 6 months)