Impact of a Topical Cosmetic Product on Women's Hair

Hair Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06060834
• Other study ID #: PRO-FY2024-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 3, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: September 2023
• Source: University of Memphis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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 a-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)

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Hair Loss
• Hair Thinning
• Hypotrichosis

Intervention

Dietary Supplement:
• Topical Botanical Agent
Cayenne Pepper, Coconut Water, Kelp, Lemon Juice, Oxynex LM, Potassium Sorbate, Red Palm Oil, Rose Water, Saw Palmetto, vitamin C

Locations

Country	Name	City	State
United States	Center for Nutraceutical and Dietary Supplement Research	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Memphis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hair Density	Hair density as determined by "MyHairCounts" application	baseline
Primary	Hair Density	Hair density as determined by "MyHairCounts" application	After 2 weeks of treatment
Primary	Hair Density	Hair density as determined by "MyHairCounts" application	after 1 month of treatment
Primary	60 second hair count	Number of hairs lost when hair is combed for 60 seconds	baseline
Primary	60 second hair count	Number of hairs lost when hair is combed for 60 seconds	After 2 weeks of treatment
Primary	60 second hair count	Number of hairs lost when hair is combed for 60 seconds	after 1 month of treatment
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Systolic Blood pressure	measured using an automated machine in millimeters of mercury	baseline
Secondary	Diastolic Blood pressure	measured using an automated machine in millimeters of mercury	baseline
Secondary	Diastolic Blood pressure	measured using an automated machine in millimeters of mercury	After 2 weeks of treatment
Secondary	Systolic Blood pressure	measured using an automated machine in millimeters of mercury	After 2 weeks of treatment
Secondary	Diastolic Blood pressure	measured using an automated machine in millimeters of mercury	After 1 month of treatment
Secondary	Systolic Blood pressure	measured using an automated machine in millimeters of mercury	After 1 month of treatment
Secondary	Heart Rate	measured using an automated machine in beats per minute	baseline
Secondary	Heart Rate	measured using an automated machine in beats per minute	After 2 weeks of treatment
Secondary	Heart Rate	measured using an automated machine in beats per minute	After 1 month of treatment