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NCT Number: NCT06146166

The Effects 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Skin and Research

Sacramento, California, 95815, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral herbal supplement

Dietary Supplement

Oral supplement containing an oral blend taken once daily

Oral placebo supplement

Dietary Supplement

Oral placebo supplement taken once daily

Primary outcomes

  1. Hair density

    Time frame: 24 weeks

    Change in hair density as measured by Trichogram based photographic analysis

Secondary outcomes

  1. Hair density

    Time frame: 4 weeks

    Change in hair density as measured by Trichogram based photographic analysis

  2. Hair diameter

    Time frame: 24 weeks

    Change in hair diameter and hair diameter

  3. Hair diameter

    Time frame: 4 weeks

    Change in hair diameter and hair diameter

  4. Shannon diversity of hair microbiome

    Time frame: 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

    Time frame: 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 investigator

    Time frame: 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

    Time frame: 4 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.

  8. Self-perception of hair

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Integrative Skin Science and Research

Industry

Collaborators

  • Vidya Herbs (Sponsor)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 24, 2023
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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