Hair ThinningNCT06362941
Evaluation of an Oral Hair Supplement to Improve Hair Strength and Support Growth in Women and Men
A study testing Nutrafol Women's Hair Growth Supplemnt, Nutrafol Women's Balance Hair Growth Supplement and Nutrafol Women's Vegan Hair Growth Supplement in people with Hair Thinning, run by Nutraceutical Wellness Inc. at 1 site in United States.
Trial summary
A single-center, open-label, prospective study to demonstrate the efficacy of an oral supplement to improve the strength and support the growth of thinning hair in men and women with self-perceived hair thinning. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hair Thinning
- What is being tested?
- Nutrafol Women's Hair Growth Supplemnt, Nutrafol Women's Balance Hair Growth Supplement and Nutrafol Women's Vegan Hair Growth Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2024to 18 Feb 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female or male subjects with concerns and/or signs of hair thinning.
- The subjects must meet the age characteristics based on their supplement group assignment.
- Subjects are Fitzpatrick Skin Types I to VI.
- Subjects must be in good general health.
- Subjects must be classified with thinning hair by the study dermatologist.
- Willing to maintain the same hair length, hairstyle, and coloring practices for the duration of the study. Subjects who have color-treated hair must have the color treatment performed at the same time interval prior to each visit.
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- Willing to use a mild non-medicated shampoo and conditioner for the duration of the study (medicated shampoo and conditioner refer to any prescription shampoo or conditioner as well as any over-the counter medicated shampoo or conditioner, such as those for treatment of dandruff or promoting hair growth).
- Willing and able to adhere to the same dietary lifestyles for the duration of the study
- Subjects must express willingness to cooperate with the investigator and comply to study requirements.
- Subjects must demonstrate the ability to read and understand all the items in the informed consent document.
- Subjects must agree not to use any other hair supplements or start a new vitamin supplement during the study.
- Subject has signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects."
- Subject is dependable and able to follow directions and is willing to comply with the schedule of visits.
Who cannot join
- Any previous or current acute or chronic medical or hair condition, which in the investigator's opinion, may interfere with the study results or increase the study participation risks to the subject.
- Subjects possessing signs of severe female or male pattern hair loss or alopecia (including androgenetic and traction alopecia) as determined by the study dermatologist.
- Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
- Subjects who are not willing to use only the assigned oral study supplement and no new oral supplements during the study.
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study product.
- Subjects, who are pregnant, breast feeding, or planning a pregnancy.
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- Subjects with clinically significant unstable medical disorders.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
- Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and/or follow the requirements of the study.
- Subjects with any planned surgeries and/or invasive medical procedures during the course of the study.
- History of surgical correction of hair loss on the scalp (i.e., hair transplant).
- Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within the 6 months prior to the Baseline Visit.
- Females who have recently (within the last 6 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
- hormones for birth control or HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study (the initiation of HRT or birth control should not have been associated with the initiation of hair loss/thinning).
- History of burning, flaking, itching, and stinging of the scalp.
- Utilization of low-level lasers for hair growth in the last three months.
- Known history or recent blood work indicating iron deficiency, bleeding disorders or platelet dysfunction syndrome as well as subjects receiving anticoagulant therapy or smokers with usage >20 cigarettes/day.
- Use of any medications or medicated shampoos that are known to potentially cause hair loss or affect hair growth, as determined by the Investigator or qualified sub-investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Consulting Services
High Point, North Carolina, 27262
About this study
Official title: A Single-Center Prospective Evaluation of an Oral Hair Supplement to Improve Hair Strength and Support Growth in Women and Men with Self-Perceived Hair Thinning
A single-center, open-label, prospective study to demonstrate the efficacy of an oral supplement to improve the strength and support the growth of thinning hair in men and women with self-perceived hair thinning.
Read the detailed description
Female and male subjects will be enrolled in this single-site, open-label, prospective, interventional study evaluating 5 treatment regimens to improve the appearance of thinning hair. All treatment regimens are commercially available nutraceutical hair growth supplements. 50 subjects will be enrolled into each of the 5 supplement groups. Subjects will undergo a baseline, 90 day, and 180 day visit and will have compliance phone calls at Days 45 and 135. Study assessments will include a dermatologist investigator hair assessment, a hair pull test, light microscope hair shaft diameter assessment, and a subject questionnaire.
- Conditions
- Hair Thinning
- Being tested
- Nutrafol Women's Hair Growth Supplemnt, Nutrafol Women's Balance Hair Growth Supplement, Nutrafol Women's Vegan Hair Growth Supplement, Nutrafol Women's Postpartum Hair Growth Supplement, Nutrafol Men's Hair Growth Supplement
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrafol Women's Hair Growth SupplemntDietary supplement
Hair growth supplement for women ages 18 - 44.
Nutrafol Women's Balance Hair Growth SupplementDietary supplement
Hair growth supplement for women ages 45 - 70.
Nutrafol Women's Vegan Hair Growth SupplementDietary supplement
Hair growth supplement for women ages 18 - 44. This treatment group may also include subjects who do not follow a plant-based diet for purposes of extending the product claims beyond the initially studied demographic of women primarily adhering to a plant-based diet.
Nutrafol Women's Postpartum Hair Growth SupplementDietary supplement
Hair growth supplement for women ages 18 - 44. This product will be studied in the general women population and not postpartum women.
Nutrafol Men's Hair Growth SupplementDietary supplement
Hair growth supplement for men ages 25 - 50.
| Study group | Role | What they receive |
|---|---|---|
| Nutrafol Hair Growth Supplement | Experimental | 5 commercially available hair growth nutraceuticals will be evaluated. Treatment groups will be assigned according to the investigator's discretion. Efficacy comparisons will not be made across treatment groups. Receives: Dietary Supplement: Nutrafol Women's Hair Growth Supplemnt; Dietary Supplement: Nutrafol Women's Balance Hair Growth Supplement; Dietary Supplement: Nutrafol Women's Vegan Hair Growth Supplement; Dietary Supplement: Nutrafol Women's Postpartum Hair Growth Supplement; Dietary Supplement: Nutrafol Men's Hair Growth Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hair shaft diameter compared to baseline at Day 180.
The ability of an oral supplement to improve hair shaft strength as evidenced by change in hair shaft diameter from baseline at Day 180 in new scalp hair growth as viewed by the study dermatologist under a light microscope in men and women with self-perceived thinning hair.
Measured: 180 days
Change in hair shaft diameter compared to baseline at Day 90.
The ability of an oral supplement to improve hair shaft strength as evidenced by change in hair shaft diameter from baseline at Day 90 in new scalp hair growth as viewed by the study dermatologist under a light microscope in men and women with self-perceived thinning hair.
Measured: 90 days
Secondary outcomes (8)
Change in broken hairs recovered from the hair pull test compared to baseline at Day 180
The ability of an oral supplement to improve hair strength as evidenced by a change in the number of broken hairs recovered from the hair pull test at Day 180 compared to baseline in men and women with self-perceived thinning hair.
Measured: 180 days
Change in broken hairs recovered from the hair pull test compared to baseline at Day 90
The ability of an oral supplement to improve hair strength as evidenced by a change in the number of broken hairs recovered from the hair pull test at Day 90 compared to baseline in men and women with self-perceived thinning hair.
Measured: 90 days
Change in hair breakage during the hair pull test compared to baseline at Day 180
The ability of an oral supplement to promote longer hair as evidenced by change in hair breakage observed in the hair pull test compared to baseline at Day 180.
Measured: 180 Days
Change in hair breakage during the hair pull test compared to baseline at Day 90
The ability of an oral supplement to promote longer hair as evidenced by change in hair breakage observed in the hair pull test compared to baseline at Day 90.
Measured: 90 Days
Change in the number of hairs recovered from the hair pull test compared to baseline at Day 180
The ability of an oral supplement to improve hair shedding as evidenced by a change in the number of hairs recovered from the hair pull test compared to baseline at Day 180 in men and women with self-perceived thinning hair.
Measured: 180 Days
Change in the number of hairs recovered from the hair pull test compared to baseline at Day 90
The ability of an oral supplement to improve hair shedding as evidenced by a change in the number of hairs recovered from the hair pull test compared to baseline at Day 90 in men and women with self-perceived thinning hair.
Measured: 90 Days
Subject Self-Perceived Improvement in Hair Quality at Day 180
The ability of an oral supplement to improve hair growth and quality in men and women with self-perceived thinning hair as measured by self-assessment questionnaires using a 5-point ordinal scale (0=excellent, 1=good, 2=average, 3=poor, 4=very poor) at Day 180.
Measured: 180 Days
Subject Self-Perceived Improvement in Hair Quality at Day 90
The ability of an oral supplement to improve hair growth and quality in men and women with self-perceived thinning hair as measured by self-assessment questionnaires using a 5-point ordinal scale (0=excellent, 1=good, 2=average, 3=poor, 4=very poor) at Day 90.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start20 May 2024
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment 6-month, single-center, prospective interventional study
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutraceutical Wellness Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362941
- Sponsor's protocol ID
- NW-HGN-01
- Status last verified
- Sep 2024
- First submitted
- 8 Apr 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Draelos Z, Farris PK, Hazan A, Raymond I. A 6-Month, Prospective, Multi-arm Study for the Efficacy of Standardized Nutraceuticals to Improve Hair Fiber Thickness and Strength. Dermatol Ther (Heidelb). 2026 Jan;16(1):353-363. doi: 10.1007/s13555-025-01582-0. Epub 2025 Oct 31.
PubMed 41171588
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Prospective Evaluation of an Oral Hair Supplement to Improve Hair Strength and Support Growth in Women and Men with Self-Perceived Hair Thinning
- ClinicalTrials.gov ID
- NCT06362941
- Acronym / sponsor ID
- NW-HGN-01
- Conditions
- Hair Thinning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Nutraceutical Wellness Inc.Industry (pharma, biotech, devices)
- Study start
- 20 May 2024 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 12 Apr 2024 (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.
A single-center, open-label, prospective study to demonstrate the efficacy of an oral supplement to improve the strength and support the growth of thinning hair in men and women with self-perceived hair thinning.
Detailed description
Female and male subjects will be enrolled in this single-site, open-label, prospective, interventional study evaluating 5 treatment regimens to improve the appearance of thinning hair. All treatment regimens are commercially available nutraceutical hair growth supplements. 50 subjects will be enrolled into each of the 5 supplement groups. Subjects will undergo a baseline, 90 day, and 180 day visit and will have compliance phone calls at Days 45 and 135. Study assessments will include a dermatologist investigator hair assessment, a hair pull test, light microscope hair shaft diameter assessment, and a subject questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment 6-month, single-center, prospective interventional study
| Arm | Type | Receives |
|---|---|---|
| Nutrafol Hair Growth Supplement | Experimental | Dietary Supplement: Nutrafol Women's Hair Growth Supplemnt, Dietary Supplement: Nutrafol Women's Balance Hair Growth Supplement, Dietary Supplement: Nutrafol Women's Vegan Hair Growth Supplement, Dietary Supplement: Nutrafol Women's Postpartum Hair Growth Supplement, Dietary Supplement: Nutrafol Men's Hair Growth Supplement5 commercially available hair growth nutraceuticals will be evaluated. Treatment groups will be assigned according to the investigator's discretion. Efficacy comparisons will not be made across treatment groups. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female or male subjects with concerns and/or signs of hair thinning.
- The subjects must meet the age characteristics based on their supplement group assignment.
- Subjects are Fitzpatrick Skin Types I to VI.
- Subjects must be in good general health.
- Subjects must be classified with thinning hair by the study dermatologist.
Key exclusion criteria (18 listed)
- Any previous or current acute or chronic medical or hair condition, which in the investigator's opinion, may interfere with the study results or increase the study participation risks to the subject.
- Subjects possessing signs of severe female or male pattern hair loss or alopecia (including androgenetic and traction alopecia) as determined by the study dermatologist.
- Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
- Subjects who are not willing to use only the assigned oral study supplement and no new oral supplements during the study.
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study product.
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 |
|---|---|---|
| Nutrafol Women's Hair Growth SupplemntHair growth supplement for women ages 18 - 44. | Dietary supplement | Nutrafol Hair Growth Supplement |
| Nutrafol Women's Balance Hair Growth SupplementHair growth supplement for women ages 45 - 70. | Dietary supplement | Nutrafol Hair Growth Supplement |
| Nutrafol Women's Vegan Hair Growth SupplementHair growth supplement for women ages 18 - 44. This treatment group may also include subjects who do not follow a plant-based diet for purposes of extending the product claims beyond the initially studied demographic of women primarily adhering to a plant-based diet. | Dietary supplement | Nutrafol Hair Growth Supplement |
| Nutrafol Women's Postpartum Hair Growth SupplementHair growth supplement for women ages 18 - 44. This product will be studied in the general women population and not postpartum women. | Dietary supplement | Nutrafol Hair Growth Supplement |
| Nutrafol Men's Hair Growth SupplementHair growth supplement for men ages 25 - 50. | Dietary supplement | Nutrafol Hair Growth Supplement |
Primary outcome
Change in hair shaft diameter compared to baseline at Day 180.
Time frame: 180 days
The ability of an oral supplement to improve hair shaft strength as evidenced by change in hair shaft diameter from baseline at Day 180 in new scalp hair growth as viewed by the study dermatologist under a light microscope in men and women with self-perceived thinning hair.
Change in hair shaft diameter compared to baseline at Day 90.
Time frame: 90 days
The ability of an oral supplement to improve hair shaft strength as evidenced by change in hair shaft diameter from baseline at Day 90 in new scalp hair growth as viewed by the study dermatologist under a light microscope in men and women with self-perceived thinning hair.
8 secondary outcomes
Change in broken hairs recovered from the hair pull test compared to baseline at Day 180
Time frame: 180 days
Change in broken hairs recovered from the hair pull test compared to baseline at Day 90
Time frame: 90 days
Change in hair breakage during the hair pull test compared to baseline at Day 180
Time frame: 180 Days
Change in hair breakage during the hair pull test compared to baseline at Day 90
Time frame: 90 Days
Change in the number of hairs recovered from the hair pull test compared to baseline at Day 180
Time frame: 180 Days
Change in the number of hairs recovered from the hair pull test compared to baseline at Day 90
Time frame: 90 Days
Subject Self-Perceived Improvement in Hair Quality at Day 180
Time frame: 180 Days
Subject Self-Perceived Improvement in Hair Quality at Day 90
Time frame: 90 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Derived from this study: PubMed 41171588Draelos Z, Farris PK, Hazan A, Raymond I. A 6-Month, Prospective, Multi-arm Study for the Efficacy of Standardized Nutraceuticals to Improve Hair Fiber Thickness and Strength. Dermatol Ther (Heidelb). 2026 Jan;16(1):353-363. doi: 10.1007/s13555-025-01582-0. Epub 2025 Oct 31.
- 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 Nutrafol Women's Hair Growth Supplemnt, Nutrafol Women's Balance Hair Growth Supplement and Nutrafol Women's Vegan Hair Growth Supplement in people with Hair Thinning, run by Nutraceutical Wellness Inc. 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 13 inclusion and 18 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: finished, as of the sponsor's last update on 11 Mar 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in hair shaft diameter compared to baseline at Day 180. (time frame: 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06362941, which also lists 1 linked publication.
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 11 Mar 2025.