Clinical trial NCT06060834: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hair Thinning
Hair Loss
Lead sponsor: University of Memphis
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 14
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pre-post experiment
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Hair Density
timeFrame: baseline
measure: Hair Density
timeFrame: After 2 weeks of treatment
measure: Hair Density
timeFrame: after 1 month of treatment
measure: 60 second hair count
timeFrame: baseline
measure: 60 second hair count
timeFrame: After 2 weeks of treatment
measure: 60 second hair count
timeFrame: after 1 month of treatment
measure: Self-assessment of well-being
timeFrame: baseline
measure: Self-assessment of well-being
timeFrame: After 2 weeks of treatment
measure: Self-assessment of well-being
timeFrame: After 1 month treatment
measure: Product assessment
timeFrame: after 1 month of treatment
measure: Self-assessment of hair
timeFrame: baseline
measure: Self-assessment of hair
timeFrame: After 2 weeks of treatment
measure: Self-assessment of hair
timeFrame: After 1 month of treatment
Secondary outcomes:
measure: Systolic Blood pressure
timeFrame: baseline
measure: Diastolic Blood pressure
timeFrame: baseline
measure: Diastolic Blood pressure
timeFrame: After 2 weeks of treatment
measure: Systolic Blood pressure
timeFrame: After 2 weeks of treatment
measure: Diastolic Blood pressure
timeFrame: After 1 month of treatment
measure: Systolic Blood pressure
timeFrame: After 1 month of treatment
measure: Heart Rate
timeFrame: baseline
measure: Heart Rate
timeFrame: After 2 weeks of treatment
measure: Heart Rate
timeFrame: After 1 month of treatment
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Center for Nutraceutical and Dietary Supplement Research
state: Tennessee
Study officials:
affiliation: University of Memphis
name: Richard Bloomer, PhD
role: PRINCIPAL_INVESTIGATOR
References: