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

ConditionHair Graying
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-60
SponsorUnilever R&D

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • U82

    Other intervention

    Cosmetic scalp leave on product

  • Z63

    Other intervention

    Cosmetic scalp leave on product

Treatment groups

380 Participants
are divided into 2 treatment groups
Group A: Cosmetic product U82Experimental treatment 1 intervention
Group B: Cosmetic product Z63Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Visual assessment of percent gray hair

Percent gray hair assessed over the whole head by expert assessor

Time frame
0 - 6 months
2

Image analysis of appearance of gray hair

Image analysis of global photographs of the head

Time frame
0 - 6 months

Secondary outcomes

1

Image analysis of individual hair fibre color

Image analysis of macro photographs of selected areas of the scalp

Time frame
0 - 6 months
2

Consumer perception of scalp and hair condition and hair grayness

Questionnaires

Time frame
0 - 6 months

Other outcomes

1

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

Time frame
0 - 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Unilever R&D

Lead sponsor

Comprehensive Research Group, Inc.

Collaborator