Clinical trial NCT06146166: The Effects of an Oral Hair Supplement on Hair Density, Growth, and Microbiome
Official title: Prospective, Double-Blinded, Randomized Placebo Controlled Trial of an Oral Hair Supplement on Hair Density, Growth, and Microbiome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hair Thinning
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Vidya Herbs (Sponsor)
First posted: 2023-11-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess how an oral herbal supplement influences hair density, shine, growth, and microbiome.

Detailed description: Hair thinning and hair loss are highly prevalent conditions affecting both men and women. Various factors can contribute to hair thinning and loss, including nutrition, medications, family history, and more. Overall, hair thinning and loss have a significant impact on quality of life and patients with these concerns have limited options. For example, minoxidil, finasteride, hair transplantations, and platelet rich plasma are effective options but each are paired with their own limitations. Thus, those with hair thinning or loss are increasingly turning to natural therapies shown to improve hair density and self-perceived hair thinning.

Nutrition is closely related to hair health, as evidenced by hair thinning and loss that occur with malnutrition or restrictive diets. Additionally, the hair follicle microbiome has been shown to modulate inflammation that exacerbates inflammatory scalp diseases, and ultimately hair thinning and hair loss.

Thus, an oral supplement that addresses nutrient deficiencies and targets the hair follicle microbiome could support hair health. In this study, we examine the effects of an herbal oral supplement on hair density, shine, and growth.

Eligibility criteria: Inclusion Criteria:

- Men and women between the ages of 25 years old and 65 years old with self-perceived hair thinning.

Exclusion Criteria:

* Individuals who are pregnant or breastfeeding.
* Prisoners.
* Adults unable to consent.
* Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
* Subjects with scarring forms of alopecia.
* Any history of procedures affecting hair growth, such as transplantation
* Any known allergy to any of the ingredients in the study product.
* Any laser treatments for hair growth in the past 3 months
* Use of any over-the-counter or pharmaceutical or dietary products known to affect hair growth
* Subjects unwilling to not alter hair color or style for the duration of the study.
* Subjects taking any hair growth oral supplementation within the past 3 months.
* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
* Those who have been on an oral antibiotic within 1 month prior enrolling
* Those who are unwilling to discontinue oral probiotics-based supplementation or supplement ingredients found in the study's oral, product 1 month prior to enrollment

Primary outcomes:
measure: Hair density
timeFrame: 24 weeks
Secondary outcomes:
measure: Hair density
timeFrame: 4 weeks
measure: Hair diameter
timeFrame: 24 weeks
measure: Hair diameter
timeFrame: 4 weeks
measure: Shannon diversity of hair microbiome
timeFrame: 24 weeks
measure: Hair health measured by global photographs as subjective factors graded by the investigator
timeFrame: 4 weeks
measure: Hair health measured by global photographs as subjective factors graded by the investigator
timeFrame: 24 weeks
measure: Self-perception of hair
timeFrame: 4 weeks
measure: Self-perception of hair
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin and Research
state: California
Study officials:
References: