A single-center, open-label, prospective study to demonstrate the efficacy of an oral supplement to improve the strength and support the growth of thinning hair in men and women with self-perceived hair thinning.
Female and male subjects will be enrolled in this single-site, open-label, prospective, interventional study evaluating 5 treatment regimens to improve the appearance of thinning hair. All treatment regimens are commercially available nutraceutical hair growth supplements. 50 subjects will be enrolled into each of the 5 supplement groups. Subjects will undergo a baseline, 90 day, and 180 day visit and will have compliance phone calls at Days 45 and 135. Study assessments will include a dermatologist investigator hair assessment, a hair pull test, light microscope hair shaft diameter assessment, and a subject questionnaire.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Hair growth supplement for women ages 18 - 44.
Hair growth supplement for women ages 45 - 70.
Hair growth supplement for women ages 18 - 44. This treatment group may also include subjects who do not follow a plant-based diet for purposes of extending the product claims beyond the initially studied demographic of women primarily adhering to a plant-based diet.
Dermatology Consulting Services
High Point, North Carolina, United States
Change in hair shaft diameter compared to baseline at Day 180.
The ability of an oral supplement to improve hair shaft strength as evidenced by change in hair shaft diameter from baseline at Day 180 in new scalp hair growth as viewed by the study dermatologist under a light microscope in men and women with self-perceived thinning hair.
Time frame: 180 days
Change in hair shaft diameter compared to baseline at Day 90.
The ability of an oral supplement to improve hair shaft strength as evidenced by change in hair shaft diameter from baseline at Day 90 in new scalp hair growth as viewed by the study dermatologist under a light microscope in men and women with self-perceived thinning hair.
Time frame: 90 days
Change in broken hairs recovered from the hair pull test compared to baseline at Day 180
The ability of an oral supplement to improve hair strength as evidenced by a change in the number of broken hairs recovered from the hair pull test at Day 180 compared to baseline in men and women with self-perceived thinning hair.
Time frame: 180 days
Change in broken hairs recovered from the hair pull test compared to baseline at Day 90
The ability of an oral supplement to improve hair strength as evidenced by a change in the number of broken hairs recovered from the hair pull test at Day 90 compared to baseline in men and women with self-perceived thinning hair.
Time frame: 90 days
Change in hair breakage during the hair pull test compared to baseline at Day 180
The ability of an oral supplement to promote longer hair as evidenced by change in hair breakage observed in the hair pull test compared to baseline at Day 180.
Time frame: 180 Days
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Hair growth supplement for women ages 18 - 44. This product will be studied in the general women population and not postpartum women.
Hair growth supplement for men ages 25 - 50.
Change in hair breakage during the hair pull test compared to baseline at Day 90
The ability of an oral supplement to promote longer hair as evidenced by change in hair breakage observed in the hair pull test compared to baseline at Day 90.
Time frame: 90 Days
Change in the number of hairs recovered from the hair pull test compared to baseline at Day 180
The ability of an oral supplement to improve hair shedding as evidenced by a change in the number of hairs recovered from the hair pull test compared to baseline at Day 180 in men and women with self-perceived thinning hair.
Time frame: 180 Days
Change in the number of hairs recovered from the hair pull test compared to baseline at Day 90
The ability of an oral supplement to improve hair shedding as evidenced by a change in the number of hairs recovered from the hair pull test compared to baseline at Day 90 in men and women with self-perceived thinning hair.
Time frame: 90 Days
Subject Self-Perceived Improvement in Hair Quality at Day 180
The ability of an oral supplement to improve hair growth and quality in men and women with self-perceived thinning hair as measured by self-assessment questionnaires using a 5-point ordinal scale (0=excellent, 1=good, 2=average, 3=poor, 4=very poor) at Day 180.
Time frame: 180 Days
Subject Self-Perceived Improvement in Hair Quality at Day 90
The ability of an oral supplement to improve hair growth and quality in men and women with self-perceived thinning hair as measured by self-assessment questionnaires using a 5-point ordinal scale (0=excellent, 1=good, 2=average, 3=poor, 4=very poor) at Day 90.
Time frame: 90 Days