Impact of a Topical Cosmetic Product on Women's Hair

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

Study Overview

• Status: Completed
• Conditions: Hair Loss; Hair Thinning
• Intervention / Treatment: Dietary supplement: Topical Botanical Agent

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38152
      • Center for Nutraceutical and Dietary Supplement Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Application of product; Apply intervention to wet hair on scalp and massage in for 30 seconds after shampooing (if applicable), daily.	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Memphis
• Investigators: Principal Investigator: Richard Bloomer, PhD, University of Memphis

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2023
• Primary Completion (Actual): December 14, 2023
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 5, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hair Diseases; Alopecia Areata; Alopecia; Hypotrichosis
• Other Study ID Numbers: PRO-FY2024-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No