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

Prospective, Double-Blinded, Randomized Placebo Controlled Trial of an Oral Hair Supplement on Hair Density, Growth, and Microbiome

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hair Thinning
• Intervention / Treatment: Dietary supplement: Oral herbal supplement; Dietary supplement: Oral placebo supplement

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Integrative Skin and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral herbal supplement; Oral supplement containing an herbal blend	Dietary supplement: Oral herbal supplement; Oral supplement containing an oral blend taken once daily
Placebo Comparator: Oral Placebo Supplement; Oral placebo supplement	Dietary supplement: Oral placebo supplement; Oral placebo supplement taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair density	Change in hair density as measured by Trichogram based photographic analysis	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair density	Change in hair density as measured by Trichogram based photographic analysis	4 weeks
Hair diameter	Change in hair diameter and hair diameter	24 weeks
Hair diameter	Change in hair diameter and hair diameter	4 weeks
Shannon diversity of hair microbiome	Shift in Shannon diversity measure of the hair microbiome	24 weeks
Hair health measured by global photographs as subjective factors graded by the investigator	Change in hair growth, density, and shine measured by global photographs as subjective factors graded by the investigator	4 weeks
Hair health measured by global photographs as subjective factors graded by the investigator	Change in hair growth, density, and shine measured by global photographs as subjective factors graded by the investigator	24 weeks
Self-perception of hair	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.	4 weeks
Self-perception of hair	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.	24 weeks

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Vidya Herbs (Sponsor)

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2024
• Primary Completion (Estimated): January 10, 2025
• Study Completion (Estimated): January 10, 2025

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hair Diseases; Alopecia; Alopecia Areata; Hypotrichosis
• Other Study ID Numbers: i23-10-VIDYA_HAIR_SUPP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No