Prospective, Double-Blinded, Randomized Placebo Controlled Trial of an Oral Hair Supplement on Hair Density, Growth, and Microbiome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hair Thinning
- Sponsor
- Integrative Skin Science and Research
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Hair density
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Hair density
Time Frame: 24 weeks
Change in hair density as measured by Trichogram based photographic analysis
Secondary Outcomes
- Hair density(4 weeks)
- Shannon diversity of hair microbiome(24 weeks)
- Hair diameter(4 weeks)
- Hair health measured by global photographs as subjective factors graded by the investigator(24 weeks)
- Self-perception of hair(24 weeks)