Hair ThinningNCT06060834
Impact of a Topical Cosmetic Product on Women's Hair
A study testing Topical Botanical Agent in people with Hair Thinning and Hair Loss, run by University of Memphis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Thinning, Hair Loss
- What is being tested?
- Topical Botanical Agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2023to 25 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38152
About this study
Official title: 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.
Read the 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.
- Conditions
- Hair Thinning, Hair Loss
- Being tested
- Topical Botanical Agent
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Botanical AgentDietary supplement
Cayenne Pepper, Coconut Water, Kelp, Lemon Juice, Oxynex LM, Potassium Sorbate, Red Palm Oil, Rose Water, Saw Palmetto, vitamin C
| Study group | Role | What they receive |
|---|---|---|
| Application of product | Experimental | Apply intervention to wet hair on scalp and massage in for 30 seconds after shampooing (if applicable), daily. Receives: Dietary Supplement: Topical Botanical Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Density
Hair density as determined by "MyHairCounts" application
Measured: baseline
Hair Density
Hair density as determined by "MyHairCounts" application
Measured: After 2 weeks of treatment
Hair Density
Hair density as determined by "MyHairCounts" application
Measured: after 1 month of treatment
60 second hair count
Number of hairs lost when hair is combed for 60 seconds
Measured: baseline
60 second hair count
Number of hairs lost when hair is combed for 60 seconds
Measured: After 2 weeks of treatment
60 second hair count
Number of hairs lost when hair is combed for 60 seconds
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: After 1 month of treatment
Secondary outcomes (9)
Systolic Blood pressure
measured using an automated machine in millimeters of mercury
Measured: baseline
Diastolic Blood pressure
measured using an automated machine in millimeters of mercury
Measured: baseline
Diastolic Blood pressure
measured using an automated machine in millimeters of mercury
Measured: After 2 weeks of treatment
Systolic Blood pressure
measured using an automated machine in millimeters of mercury
Measured: After 2 weeks of treatment
Diastolic Blood pressure
measured using an automated machine in millimeters of mercury
Measured: After 1 month of treatment
Systolic Blood pressure
measured using an automated machine in millimeters of mercury
Measured: After 1 month of treatment
Heart Rate
measured using an automated machine in beats per minute
Measured: baseline
Heart Rate
measured using an automated machine in beats per minute
Measured: After 2 weeks of treatment
Heart Rate
measured using an automated machine in beats per minute
Measured: After 1 month of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start3 Aug 2023
- Primary completion14 Dec 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair ThinningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pre-post experiment
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Bloomer, University of Memphis
- Investigators
- Richard Bloomer, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060834
- Sponsor's protocol ID
- PRO-FY2024-1
- Status last verified
- Apr 2025
- First submitted
- 22 Sep 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Topical Cosmetic Product Intended to Promote the Health and Beauty of Women's Hair
- ClinicalTrials.gov ID
- NCT06060834
- Acronym / sponsor ID
- PRO-FY2024-1
- Conditions
- Hair Thinning, Hair Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pre-post experiment
| Arm | Type | Receives |
|---|---|---|
| Application of product | Experimental | Dietary Supplement: Topical Botanical AgentApply intervention to wet hair on scalp and massage in for 30 seconds after shampooing (if applicable), daily. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Botanical AgentCayenne Pepper, Coconut Water, Kelp, Lemon Juice, Oxynex LM, Potassium Sorbate, Red Palm Oil, Rose Water, Saw Palmetto, vitamin C | Dietary supplement | Application of product |
Primary outcome
Hair Density
Time frame: baseline
Hair density as determined by "MyHairCounts" application
Hair Density
Time frame: After 2 weeks of treatment
Hair density as determined by "MyHairCounts" application
Hair Density
Time frame: after 1 month of treatment
Hair density as determined by "MyHairCounts" application
60 second hair count
Time frame: baseline
Number of hairs lost when hair is combed for 60 seconds
60 second hair count
Time frame: After 2 weeks of treatment
Number of hairs lost when hair is combed for 60 seconds
60 second hair count
Time frame: after 1 month of treatment
Number of hairs lost when hair is combed for 60 seconds
Self-assessment of well-being
Time frame: baseline
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
Time frame: After 2 weeks of treatment
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
Time frame: After 1 month treatment
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
Time frame: after 1 month of treatment
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
Time frame: baseline
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
Time frame: After 2 weeks of treatment
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
Time frame: After 1 month of treatment
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).
9 secondary outcomes
Systolic Blood pressure
Time frame: baseline
Diastolic Blood pressure
Time frame: baseline
Diastolic Blood pressure
Time frame: After 2 weeks of treatment
Systolic Blood pressure
Time frame: After 2 weeks of treatment
Diastolic Blood pressure
Time frame: After 1 month of treatment
Systolic Blood pressure
Time frame: After 1 month of treatment
Heart Rate
Time frame: baseline
Heart Rate
Time frame: After 2 weeks of treatment
Heart Rate
Time frame: After 1 month of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Bloomer, PhD principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Botanical Agent in people with Hair Thinning and Hair Loss, run by University of Memphis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair Density (time frame: baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.