About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
U82
Other interventionCosmetic scalp leave on product
Z63
Other interventionCosmetic scalp leave on product
Treatment groups
Trial outcomes
Primary outcomes
Visual assessment of percent gray hair
Percent gray hair assessed over the whole head by expert assessor
Image analysis of appearance of gray hair
Image analysis of global photographs of the head
Secondary outcomes
Image analysis of individual hair fibre color
Image analysis of macro photographs of selected areas of the scalp
Consumer perception of scalp and hair condition and hair grayness
Questionnaires
Other outcomes
Proteomic analysis of scalp surface proteins associated with scalp and hair health
Sponsors and contacts
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Unilever R&D
Lead sponsor
Comprehensive Research Group, Inc.
Collaborator