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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrafol Hair Growth Supplement | Experimental | 4 commercially available hair growth nutraceuticals will be evaluated. Treatment groups will be assigned according to the investigator's discretion. Efficacy comparisons will not be made across treatment groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrafol Women's Hair Growth Supplement | Dietary Supplement | Hair growth supplement for women ages 18 - 44 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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®. | 90 Days |
| The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Skin Science and Research | Sacramento | California | 95815 | United States |
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Single Group Assignment 6-month, single-center, prospective interventional study
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| Nutrafol Women's Balance Hair Growth Supplement | Dietary Supplement | Hair growth supplement for women ages 45 - 70 |
|
| Nutrafol Women's Vegan Hair Growth Supplement | Dietary Supplement | 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 |
|
| Nutrafol Women's Postpartum Hair Growth Supplement | Dietary Supplement | 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 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. |
| 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. | 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. | 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. | 180 Days |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 180 Days |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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