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

Hair Thinning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06146166
• Other study ID #: i23-10-VIDYA_HAIR_SUPP
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: June 2024
• Source: Integrative Skin Science and Research
• Contact: Mildred Min
• Phone: 916-750-2463
• Email: mildred[@]integrativeskinresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Hair Thinning
• Hypotrichosis

Intervention

Dietary Supplement:
• Oral herbal supplement
Oral supplement containing an oral blend taken once daily
• Oral placebo supplement
Oral placebo supplement taken once daily

Locations

Country	Name	City	State
United States	Integrative Skin and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Vidya Herbs (Sponsor)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hair density	Change in hair density as measured by Trichogram based photographic analysis	24 weeks
Secondary	Hair density	Change in hair density as measured by Trichogram based photographic analysis	4 weeks
Secondary	Hair diameter	Change in hair diameter and hair diameter	24 weeks
Secondary	Hair diameter	Change in hair diameter and hair diameter	4 weeks
Secondary	Shannon diversity of hair microbiome	Shift in Shannon diversity measure of the hair microbiome	24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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