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

Sponsor
Integrative Skin Science and Research (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06146166
Collaborator
Vidya Herbs (Other)
60
2
11

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Oral herbal supplement
  • Dietary Supplement: Oral placebo supplement
N/A

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.1 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.2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Prospective, Double-Blinded, Randomized Placebo Controlled Trial of an Oral Hair Supplement on Hair Density, Growth, and Microbiome
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Hair density [24 weeks]

    Change in hair density as measured by trichogram based photographic analysis

Secondary Outcome Measures

  1. Hair density [4 weeks]

    Change in hair density as measured by trichogram based photographic analysis

  2. Hair diameter [24 weeks]

    Change in hair diameter and hair diameter

  3. Hair diameter [4 weeks]

    Change in hair diameter and hair diameter

  4. Shannon diversity of hair microbiome [24 weeks]

    Shift in Shannon diversity measure of the hair microbiome

  5. Hair health measured by global photographs as subjective factors graded by the investigator [4 weeks]

    Change in hair growth, density, and shine measured by global photographs as subjective factors graded by the investigator

  6. Hair health measured by global photographs as subjective factors graded by the investigato [24 weeks]

    Change in hair growth, density, and shine measured by global photographs as subjective factors graded by the investigator

  7. Self-perception of hair [4 weeks]

    Survey based self grading of hair growth, density, and shine measured with subjective questionnaire

  8. Self-perception of hair [24 weeks]

    Survey based self grading of hair growth, density, and shine measured with subjective questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Integrative Skin Science and Research
  • Vidya Herbs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Integrative Skin Science and Research
ClinicalTrials.gov Identifier:
NCT06146166
Other Study ID Numbers:
  • i23-10-VIDYA_HAIR_SUPP
First Posted:
Nov 24, 2023
Last Update Posted:
Nov 24, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2023