A single site open label interventional study evaluating currently marketed hair supplements targeting the underlying root causes of thinning hair.
A single site open label interventional study evaluating currently marketed hair supplements targeting the underlying root causes of thinning hair. All treatment regimens are commercially available nutraceutical hair growth supplements. 45 subjects will be enrolled into each of the 4 supplement groups. Subjects will undergo a baseline, baseline + 48 hours, 90 day, 90 day + 48 hours, 180 day and 180 day + 48 hours visit and will have compliance phone calls at Days 45 and 135. All subject data will be compared to baseline in paired comparison for each subject using a historical control.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
181
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
Integrative Skin Science and Research
Sacramento, California, United States
The percent change in hair growth rate at Day 180 relative to baseline (Day 0)
The percent change in hair growth rate at Day 180 relative to baseline (Day 0) using Canfield HairMetrix® non-invasive device.
Time frame: 180 days
The percent change in hair growth rate at Day 90 relative to baseline (Day 0)
The percent change in hair growth rate at Day 90 relative to baseline (Day 0) as measured by the Canfield HairMetrix®.
Time frame: 90 Days
The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 90 days
The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 90 days as measured by the Canfield HairMetrix® compared to baseline.
Time frame: 90 days
The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 180 days
The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 180 days as measured by the Canfield HairMetrix® compared to baseline.
Time frame: 180 days
The change in terminal to vellus ratio
The change in terminal to vellus ratio as measured by the Canfield HairMetrix® at 90 days compared to baseline.
Time frame: 90 Days
The change in terminal to vellus ratio
The change in terminal to vellus ratio as measured by the Canfield HairMetrix® at 180 days compared to baseline.
Time frame: 180 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hair growth supplement for women ages 18 - 44. This product will be studied in the general women population and not postpartum women.
The change in anagen to telogen ratio
The change in terminal to vellus ratio per cm2 as measured by the Canfield HairMetrix® at 90 days compared to baseline.
Time frame: 90 Days
The change in anagen to telogen ratio
The change in terminal to vellus ratio per cm2 as measured by the Canfield HairMetrix® at 180 days compared to baseline.
Time frame: 180 Days
The change in average number of hairs per follicular unit
The change in average number of hairs per follicular unit as measured by the Canfield HairMetrix® at 90 days compared to baseline.
Time frame: 90 Days
The change in average number of hairs per follicular unit
The change in average number of hairs per follicular unit as measured by the Canfield HairMetrix® at 180 days compared to baseline.
Time frame: 180 Days
The change in total hair width per cm2
The change in total hair width per cm2 as measured by the Canfield HairMetrix® at 90 days compared to baseline.
Time frame: 90 Days
The change in total hair width per cm2
The change in total hair width per cm2 as measured by the Canfield HairMetrix® at 180 days compared to baseline.
Time frame: 180 Days
The change in mean inter-follicular distance
The change in mean inter-follicular distance as measured by the Canfield HairMetrix® at 90 days compared to baseline.
Time frame: 90 Days
The change in mean inter-follicular distance
The change in mean inter-follicular distance as measured by the Canfield HairMetrix® at 180 days compared to baseline.
Time frame: 180 Days
Subjective assessments of change measured with Consumer Perception Questionnaire at 90 days
Subjective assessments of change in hair growth and appearance measured with Consumer Perception Questionnaire at 90 days
Time frame: 90 Days
Subjective assessments of change measured with Consumer Perception Questionnaire at 180 days
Subjective assessments of change in hair growth and appearance measured with Consumer Perception Questionnaire at 180 days
Time frame: 180 Days