The Effects of an Oral Hair Supplement on Hair Density, Growth, and Microbiome

Not Applicable

Active, not recruiting

• Conditions: Hair Thinning
• Interventions: Dietary Supplement: Oral herbal supplement; Dietary Supplement: Oral placebo supplement

• Registration Number: NCT06146166
• Lead Sponsor: Integrative Skin Science and Research

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.

Study Timeline

• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-17
• Study First Posted: 2023-11-24
• Study Start: 2024-02-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2025-01-10
• Study Completion: 2025-01-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral herbal supplement	Oral herbal supplement	Oral supplement containing an herbal blend
Oral Placebo Supplement	Oral placebo supplement	Oral placebo supplement

Primary Outcome Measures

Name	Time	Method
Hair density	24 weeks	Change in hair density as measured by Trichogram based photographic analysis

Secondary Outcome Measures

Name	Time	Method
Shannon diversity of hair microbiome	24 weeks	Shift in Shannon diversity measure of the hair microbiome
Hair density	4 weeks	Change in hair density as measured by Trichogram based photographic analysis
Hair diameter	4 weeks	Change in hair diameter and hair diameter
Hair health measured by global photographs as subjective factors graded by the investigator	24 weeks	Change in hair growth, density, and shine measured by global photographs as subjective factors graded by the investigator
Self-perception of hair	24 weeks	10-question survey based self grading of hair growth, density, and shine measured with subjective questionnaire. Answers range from Strongly Agree, Agree, Neutral, Disagree, or Strongly Disagree.

Trial Locations

Locations (1)

Integrative Skin and Research; 🇺🇸 Sacramento, California, United States