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Impact of a Topical Cosmetic Product on Women's Hair

Primary Purpose

Hair Thinning, Hair Loss

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Topical Botanical Agent
Sponsored by
University of Memphis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hair Thinning

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Center for Nutraceutical and Dietary Supplement Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Application of product

Arm Description

Apply intervention to wet hair on scalp and massage in for 30 seconds after shampooing (if applicable), daily.

Outcomes

Primary Outcome Measures

Hair Density
Hair density as determined by "MyHairCounts" application
Hair Density
Hair density as determined by "MyHairCounts" application
Hair Density
Hair density as determined by "MyHairCounts" application
60 second hair count
Number of hairs lost when hair is combed for 60 seconds
60 second hair count
Number of hairs lost when hair is combed for 60 seconds
60 second hair count
Number of hairs lost when hair is combed for 60 seconds
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).
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).
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).
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).
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).
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).
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).

Secondary Outcome Measures

Systolic Blood pressure
measured using an automated machine in millimeters of mercury
Diastolic Blood pressure
measured using an automated machine in millimeters of mercury
Diastolic Blood pressure
measured using an automated machine in millimeters of mercury
Systolic Blood pressure
measured using an automated machine in millimeters of mercury
Diastolic Blood pressure
measured using an automated machine in millimeters of mercury
Systolic Blood pressure
measured using an automated machine in millimeters of mercury
Heart Rate
measured using an automated machine in beats per minute
Heart Rate
measured using an automated machine in beats per minute
Heart Rate
measured using an automated machine in beats per minute

Full Information

First Posted
September 22, 2023
Last Updated
September 22, 2023
Sponsor
University of Memphis
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1. Study Identification

Unique Protocol Identification Number
NCT06060834
Brief Title
Impact of a Topical Cosmetic Product on Women's Hair
Official Title
Impact of a Topical Cosmetic Product Intended to Promote the Health and Beauty of Women's Hair
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 3, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Memphis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hair Thinning, Hair Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pre-post experiment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Application of product
Arm Type
Experimental
Arm Description
Apply intervention to wet hair on scalp and massage in for 30 seconds after shampooing (if applicable), daily.
Intervention Type
Dietary Supplement
Intervention Name(s)
Topical Botanical Agent
Intervention Description
Cayenne Pepper, Coconut Water, Kelp, Lemon Juice, Oxynex LM, Potassium Sorbate, Red Palm Oil, Rose Water, Saw Palmetto, vitamin C
Primary Outcome Measure Information:
Title
Hair Density
Description
Hair density as determined by "MyHairCounts" application
Time Frame
baseline
Title
Hair Density
Description
Hair density as determined by "MyHairCounts" application
Time Frame
After 2 weeks of treatment
Title
Hair Density
Description
Hair density as determined by "MyHairCounts" application
Time Frame
after 1 month of treatment
Title
60 second hair count
Description
Number of hairs lost when hair is combed for 60 seconds
Time Frame
baseline
Title
60 second hair count
Description
Number of hairs lost when hair is combed for 60 seconds
Time Frame
After 2 weeks of treatment
Title
60 second hair count
Description
Number of hairs lost when hair is combed for 60 seconds
Time Frame
after 1 month of treatment
Title
Self-assessment of well-being
Description
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).
Time Frame
baseline
Title
Self-assessment of well-being
Description
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).
Time Frame
After 2 weeks of treatment
Title
Self-assessment of well-being
Description
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).
Time Frame
After 1 month treatment
Title
Product assessment
Description
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).
Time Frame
after 1 month of treatment
Title
Self-assessment of hair
Description
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).
Time Frame
baseline
Title
Self-assessment of hair
Description
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).
Time Frame
After 2 weeks of treatment
Title
Self-assessment of hair
Description
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).
Time Frame
After 1 month of treatment
Secondary Outcome Measure Information:
Title
Systolic Blood pressure
Description
measured using an automated machine in millimeters of mercury
Time Frame
baseline
Title
Diastolic Blood pressure
Description
measured using an automated machine in millimeters of mercury
Time Frame
baseline
Title
Diastolic Blood pressure
Description
measured using an automated machine in millimeters of mercury
Time Frame
After 2 weeks of treatment
Title
Systolic Blood pressure
Description
measured using an automated machine in millimeters of mercury
Time Frame
After 2 weeks of treatment
Title
Diastolic Blood pressure
Description
measured using an automated machine in millimeters of mercury
Time Frame
After 1 month of treatment
Title
Systolic Blood pressure
Description
measured using an automated machine in millimeters of mercury
Time Frame
After 1 month of treatment
Title
Heart Rate
Description
measured using an automated machine in beats per minute
Time Frame
baseline
Title
Heart Rate
Description
measured using an automated machine in beats per minute
Time Frame
After 2 weeks of treatment
Title
Heart Rate
Description
measured using an automated machine in beats per minute
Time Frame
After 1 month of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Bloomer, PhD
Organizational Affiliation
University of Memphis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Nutraceutical and Dietary Supplement Research
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38152
Country
United States

12. IPD Sharing Statement

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Impact of a Topical Cosmetic Product on Women's Hair

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