Hair ThinningNCT06146166
The Effects of an Oral Hair Supplement on Hair Density, Growth, and Microbiome
A study testing Oral herbal supplement in people with Hair Thinning, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
The purpose of this study is to assess how an oral herbal supplement influences hair density, shine, growth, and microbiome. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Thinning
- What is being tested?
- Oral herbal supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2024to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between the ages of 25 years old and 65 years old with self-perceived hair thinning.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Skin and Research
Sacramento, California, 95815
About this study
Official title: 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.
Read the 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.
- Conditions
- Hair Thinning
- Being tested
- Oral herbal supplement, Oral placebo supplement
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral herbal supplementDietary supplement
Oral supplement containing an oral blend taken once daily
Oral placebo supplementDietary supplement
Oral placebo supplement taken once daily
| Study group | Role | What they receive |
|---|---|---|
| Oral herbal supplement | Experimental | Oral supplement containing an herbal blend Receives: Dietary Supplement: Oral herbal supplement |
| Oral Placebo Supplement | Placebo comparator | Oral placebo supplement Receives: Dietary Supplement: Oral placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair density
Change in hair density as measured by Trichogram based photographic analysis
Measured: 24 weeks
Secondary outcomes (8)
Hair density
Change in hair density as measured by Trichogram based photographic analysis
Measured: 4 weeks
Hair diameter
Change in hair diameter and hair diameter
Measured: 24 weeks
Hair diameter
Change in hair diameter and hair diameter
Measured: 4 weeks
Shannon diversity of hair microbiome
Shift in Shannon diversity measure of the hair microbiome
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start22 Feb 2024
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair ThinningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vidya Herbs (Sponsor)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146166
- Sponsor's protocol ID
- i23-10-VIDYA_HAIR_SUPP
- Status last verified
- Aug 2024
- First submitted
- 17 Nov 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-Blinded, Randomized Placebo Controlled Trial of an Oral Hair Supplement on Hair Density, Growth, and Microbiome
- ClinicalTrials.gov ID
- NCT06146166
- Acronym / sponsor ID
- i23-10-VIDYA_HAIR_SUPP
- Conditions
- Hair Thinning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Vidya Herbs (Sponsor)
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral herbal supplement | Experimental | Dietary Supplement: Oral herbal supplementOral supplement containing an herbal blend |
| Oral Placebo Supplement | Placebo comparator | Dietary Supplement: Oral placebo supplementOral placebo supplement |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women between the ages of 25 years old and 65 years old with self-perceived hair thinning.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral herbal supplementOral supplement containing an oral blend taken once daily | Dietary supplement | Oral herbal supplement |
| Oral placebo supplementOral placebo supplement taken once daily | Dietary supplement | Oral Placebo Supplement |
Primary outcome
Hair density
Time frame: 24 weeks
Change in hair density as measured by Trichogram based photographic analysis
8 secondary outcomes
Hair density
Time frame: 4 weeks
Hair diameter
Time frame: 24 weeks
Hair diameter
Time frame: 4 weeks
Shannon diversity of hair microbiome
Time frame: 24 weeks
Hair health measured by global photographs as subjective factors graded by the investigator
Time frame: 4 weeks
Hair health measured by global photographs as subjective factors graded by the investigator
Time frame: 24 weeks
Self-perception of hair
Time frame: 4 weeks
Self-perception of hair
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral herbal supplement in people with Hair Thinning, run by Integrative Skin Science and Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair density (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.