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The proposed pilot study will investigate the impact of a daily topical nutritional product applied to women's hair, specific to perceived hair quality and overall well-being. Hair loss will be measured with a scanning application ("MyHairCounts") , as well as with the 60-second hair comb test. This will be an open-label study with a sample of 15 women and will be used to generate pilot data for future, larger-scale placebo-controlled studies.
Hair loss is commonly experienced by both men and women, with a much greater focus placed on the thinning and loss of hair in women, particularly due to hormonal changes with aging. The loss of hair has biochemical origins and when pronounced, can be a major source of psychological distress which impacts quality of life. Grandview Research Group indicates that the hair and scalp market size is estimated at over $80 billion annually, with hair loss accounting for the majority of share.
Women, in particular, spend significant amounts of money annually on products and treatments specifically focused on hair growth including injections, transplants, and stem cells. While the above treatments are available through a healthcare provider, others are off-the-shelf botanical agents and dietary supplements-some of which have been shown to be effective.
While the anecdotal claims for such products are overwhelmingly positive, very few controlled laboratory studies have been done to investigate the impact of botanical agents on hair beauty and health. While objective outcomes are available (such as the number of hairs lost daily), most individuals focus on the subjective assessments of "beauty" and related items (e.g., shininess of hair, ability to comb and style hair).
The proposed pilot study will investigate the impact of a daily topical nutritional product applied to women's hair, specific to perceived hair quality and overall well-being. Hair loss will be measured with a scanning application ("MyHairCounts") , as well as with the 60-second hair comb test. This will be an open-label study with a sample of 15 women and will be used to generate pilot data for future, larger-scale placebo-controlled studies.
Considering the anecdotal results provided by women who have used the product, coupled with the fact that botanicals and nutritional factors are known to impact hair loss/health, the hypothesis is that women will experience positive results following use, both objectively and subjectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Application of product | Experimental | Apply intervention to wet hair on scalp and massage in for 30 seconds after shampooing (if applicable), daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Botanical Agent | Dietary Supplement | Cayenne Pepper, Coconut Water, Kelp, Lemon Juice, Oxynex LM, Potassium Sorbate, Red Palm Oil, Rose Water, Saw Palmetto, vitamin C |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hair Density | Hair density as determined by "MyHairCounts" application | baseline |
| Hair Density | Hair density as determined by "MyHairCounts" application | After 2 weeks of treatment |
| Hair Density | Hair density as determined by "MyHairCounts" application | after 1 month of treatment |
| 60 second hair count | Number of hairs lost when hair is combed for 60 seconds | baseline |
| 60 second hair count | Number of hairs lost when hair is combed for 60 seconds | After 2 weeks of treatment |
| 60 second hair count | Number of hairs lost when hair is combed for 60 seconds | after 1 month of treatment |
| Self-assessment of well-being | An adaptive visual analog scale will be used to self-assess feelings of confidence, self-consciousness, motivation, and attractiveness/beautifulness on a continuous scale from 0 (not at all) to 10 (extreme). | baseline |
| Self-assessment of well-being | An adaptive visual analog scale will be used to self-assess feelings of confidence, self-consciousness, motivation, and attractiveness/beautifulness on a continuous scale from 0 (not at all) to 10 (extreme). |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood pressure | measured using an automated machine in millimeters of mercury | baseline |
| Diastolic Blood pressure | measured using an automated machine in millimeters of mercury |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Bloomer, PhD | University of Memphis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Nutraceutical and Dietary Supplement Research | Memphis | Tennessee | 38152 | United States |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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pre-post experiment
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| After 2 weeks of treatment |
| Self-assessment of well-being | An adaptive visual analog scale will be used to self-assess feelings of confidence, self-consciousness, motivation, and attractiveness/beautifulness on a continuous scale from 0 (not at all) to 10 (extreme). | After 1 month treatment |
| Product assessment | An adaptive visual analog scale will be used to self-assess feelings on the smell, ease of use, and self-reported feeling of hair quality using a continuous scale from 1 (not at all) to 10 (Very much). | after 1 month of treatment |
| Self-assessment of hair | An adaptive visual analog scale will be used to self-assess feelings on subject's hair (thickness, fullness, shininess, texture, strength, appearance, satisfaction using a continuous scale from 1 (extremely poor) to 10 (Excellent) as well as compliments, split ends on a scale from 1 (Never) to 10 (Very often), ease of styling 1 (very difficult) to 10 (very easy), and speed of hair growth 1 (slow) to 10 (very fast). | baseline |
| Self-assessment of hair | An adaptive visual analog scale will be used to self-assess feelings on subject's hair (thickness, fullness, shininess, texture, strength, appearance, satisfaction using a continuous scale from 1 (extremely poor) to 10 (Excellent) as well as compliments, split ends on a scale from 1 (Never) to 10 (Very often), ease of styling 1 (very difficult) to 10 (very easy), and speed of hair growth 1 (slow) to 10 (very fast). | After 2 weeks of treatment |
| Self-assessment of hair | An adaptive visual analog scale will be used to self-assess feelings on subject's hair (thickness, fullness, shininess, texture, strength, appearance, satisfaction using a continuous scale from 1 (extremely poor) to 10 (Excellent) as well as compliments, split ends on a scale from 1 (Never) to 10 (Very often), ease of styling 1 (very difficult) to 10 (very easy), and speed of hair growth 1 (slow) to 10 (very fast). | After 1 month of treatment |
| baseline |
| Diastolic Blood pressure | measured using an automated machine in millimeters of mercury | After 2 weeks of treatment |
| Systolic Blood pressure | measured using an automated machine in millimeters of mercury | After 2 weeks of treatment |
| Diastolic Blood pressure | measured using an automated machine in millimeters of mercury | After 1 month of treatment |
| Systolic Blood pressure | measured using an automated machine in millimeters of mercury | After 1 month of treatment |
| Heart Rate | measured using an automated machine in beats per minute | baseline |
| Heart Rate | measured using an automated machine in beats per minute | After 2 weeks of treatment |
| Heart Rate | measured using an automated machine in beats per minute | After 1 month of treatment |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |