Impact of a Topical Cosmetic Product on Women's Hair

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of a Topical Cosmetic Product Intended to Promote the Health and Beauty of Women's Hair

Conditions
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Hair Thinning, Hair Loss

Intervention / Treatment
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* Dietary Supplement: Topical Botanical Agent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Age 35-70 years Subjects should have limp or visibly thin hair, and claim to have experienced mild to moderate hair thinning Willing to follow the protocol requirements as evidenced by written informed consent. Agree not to use any medication, including vitamins and minerals, or any cosmetic products during or before the course of this study, which are designed to impact hair health. Willing to download the MyHairCounts | Hair Loss Prevention | Hair Density Tracking app for use in study assessments. Willing to come to the lab for all follow-up visits. Have a regular/stable menstrual cycle if not post-menopausal (e.g., 27-32 days). Not lactating, pregnant or planning to become pregnant during the study Not have any clinically significant medical history (including alopecia), medical finding or an on-going medical or psychiatric condition which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol. Not have baldness or significant loss of hair, to the extent that the topical product would not remain on the scalp and would run off following application, or if there is such minimal or short hair that an improvement in appearance would not be able to be evaluated. Use of any medication or supplement for hair loss, including finasteride, any other 5 α-reductase inhibitor, minoxidil, steroids, or hormonal products, during the 3 months prior to study commencement. No history of allergic/sensitivity reactions to product components. Must be able to hang loose naturally (unsecured and without hair extensions)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: pre-post experiment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Application of product<br>Apply intervention to wet hair on scalp and massage in for 30 seconds after shampooing (if applicable), daily. | Dietary Supplement: Topical Botanical Agent<br>* Cayenne Pepper, Coconut Water, Kelp, Lemon Juice, Oxynex LM, Potassium Sorbate, Red Palm Oil, Rose Water, Saw Palmetto, vitamin C<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |