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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrafol Hair Growth Supplement | Experimental | 5 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 Supplemnt | Dietary Supplement | Hair growth supplement for women ages 18 - 44. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41171588 | Derived | Draelos Z, Farris PK, Hazan A, Raymond I. A 6-Month, Prospective, Multi-arm Study for the Efficacy of Standardized Nutraceuticals to Improve Hair Fiber Thickness and Strength. Dermatol Ther (Heidelb). 2026 Jan;16(1):353-363. doi: 10.1007/s13555-025-01582-0. Epub 2025 Oct 31. |
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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. |
|
| Nutrafol Men's Hair Growth Supplement | Dietary Supplement | Hair growth supplement for men ages 25 - 50. |
|
| 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. |
| 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. | 180 Days |
| 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. | 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. | 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. | 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. | 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. | 90 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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