Hair ThinningNCT06376409
Prospective Study of Nutraceutical Supplements to Support Hair Growth in Females
A study testing Nutrafol Women's Hair Growth Supplement, 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 site open label interventional study evaluating currently marketed hair supplements targeting the underlying root causes of thinning hair. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Thinning
- What is being tested?
- Nutrafol Women's Hair Growth Supplement, 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
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2024to 18 Jun 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females of all Fitzpatrick skin, and hair types between 18-70 years of age with self-perceived thinning, confirmed by a dermatologist.
- Willing and able to adhere to the same dietary lifestyles for the duration of the study.
- Able to understand and sign an informed consent agreement and photo release form approved by the Institutional Review Board
- General good health, as determined by the Investigator or qualified sub-investigator.
- Willing and able to attend all study visits and comply with the test product daily instructions.
- 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 cooperate with the requirements of the study.
- Able to complete and understand the various questionnaires.
Who cannot join
- Individuals who are pregnant, planning a pregnancy, nursing, or within 1-year post-partum.
- Individuals who have experienced serious complications due to COVID-19 previously or during the study as determined by the investigator.
- Clinical diagnosis of hair loss disorder such as alopecia areata, or scarring forms of alopecia.
- Individuals who have had a history of any acute or chronic disease that could interfere with or increase the risk on study participation.
- Individuals who have had a history of any acute or chronic medical or hair condition that could affect study results, such as a history of disordered eating.
- Scalp hair loss on the treatment area, due to disease, injury, or medical therapy.
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- Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis), infection, cuts, and/ or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the Investigator or qualified sub-investigator, might put the subject at risk or interfere with the study conduct or evaluations.
- 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 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 malignancy (except cutaneous squamous cell carcinoma and basal cell carcinoma) or currently undergoing chemotherapy or radiation treatments.
- A known history of autoimmune thyroid disease, any other thyroid disorder/abnormality or other autoimmune disorders that in the opinion of the Investigator or qualified sub-investigator may interfere with the study treatment.
- A known history of unstable or chronic depression or bipolar disease or any other condition that may impact the subject's participation in the opinion of the investigator or qualified sub-investigator.
- A known allergy to any of the ingredients in the investigational product.
- Utilization of low-level lasers for hair growth in the last three months.
- Any condition that the Investigator thinks may put the subject at risk or interfere with their participation in the study or study results.
- Known history of or current iron deficiency, bleeding disorders or platelet dysfunction syndrome as well as subjects receiving anticoagulant therapy or smokers with usage >20 cigarettes/day as reported by the subject.
- 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
Integrative Skin Science and Research
Sacramento, California, 95815
About this study
Official title: A Single-center, Prospective Study of Nutraceutical Supplements to Support Hair Growth in Females With Self-Perceived Thinning Hair
A single site open label interventional study evaluating currently marketed hair supplements targeting the underlying root causes of thinning hair.
Read the detailed description
A single site open label interventional study evaluating currently marketed hair supplements targeting the underlying root causes of thinning hair. All treatment regimens are commercially available nutraceutical hair growth supplements. 45 subjects will be enrolled into each of the 4 supplement groups. Subjects will undergo a baseline, baseline + 48 hours, 90 day, 90 day + 48 hours, 180 day and 180 day + 48 hours visit and will have compliance phone calls at Days 45 and 135. All subject data will be compared to baseline in paired comparison for each subject using a historical control.
- Conditions
- Hair Thinning
- Being tested
- Nutrafol Women's Hair Growth Supplement, Nutrafol Women's Balance Hair Growth Supplement, Nutrafol Women's Vegan Hair Growth Supplement, Nutrafol Women's Postpartum 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 SupplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Nutrafol Hair Growth Supplement | Experimental | 4 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 Supplement; 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change in hair growth rate at Day 180 relative to baseline (Day 0)
The percent change in hair growth rate at Day 180 relative to baseline (Day 0) using Canfield HairMetrix® non-invasive device.
Measured: 180 days
Secondary outcomes (15)
The percent change in hair growth rate at Day 90 relative to baseline (Day 0)
The percent change in hair growth rate at Day 90 relative to baseline (Day 0) as measured by the Canfield HairMetrix®.
Measured: 90 Days
The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 90 days
The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 90 days as measured by the Canfield HairMetrix® compared to baseline.
Measured: 90 days
The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 180 days
The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 180 days as measured by the Canfield HairMetrix® compared to baseline.
Measured: 180 days
The change in terminal to vellus ratio
The change in terminal to vellus ratio as measured by the Canfield HairMetrix® at 90 days compared to baseline.
Measured: 90 Days
The change in terminal to vellus ratio
The change in terminal to vellus ratio as measured by the Canfield HairMetrix® at 180 days compared to baseline.
Measured: 180 Days
The change in anagen to telogen ratio
The change in terminal to vellus ratio per cm2 as measured by the Canfield HairMetrix® at 90 days compared to baseline.
Measured: 90 Days
The change in anagen to telogen ratio
The change in terminal to vellus ratio per cm2 as measured by the Canfield HairMetrix® at 180 days compared to baseline.
Measured: 180 Days
The change in average number of hairs per follicular unit
The change in average number of hairs per follicular unit as measured by the Canfield HairMetrix® at 90 days compared to baseline.
Measured: 90 Days
The change in average number of hairs per follicular unit
The change in average number of hairs per follicular unit as measured by the Canfield HairMetrix® at 180 days compared to baseline.
Measured: 180 Days
The change in total hair width per cm2
The change in total hair width per cm2 as measured by the Canfield HairMetrix® at 90 days compared to baseline.
Measured: 90 Days
The change in total hair width per cm2
The change in total hair width per cm2 as measured by the Canfield HairMetrix® at 180 days compared to baseline.
Measured: 180 Days
The change in mean inter-follicular distance
The change in mean inter-follicular distance as measured by the Canfield HairMetrix® at 90 days compared to baseline.
Measured: 90 Days
The change in mean inter-follicular distance
The change in mean inter-follicular distance as measured by the Canfield HairMetrix® at 180 days compared to baseline.
Measured: 180 Days
Subjective assessments of change measured with Consumer Perception Questionnaire at 90 days
Subjective assessments of change in hair growth and appearance measured with Consumer Perception Questionnaire at 90 days
Measured: 90 Days
Subjective assessments of change measured with Consumer Perception Questionnaire at 180 days
Subjective assessments of change in hair growth and appearance measured with Consumer Perception Questionnaire at 180 days
Measured: 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start6 May 2024
- Primary completion18 Jun 2025
- Study completion18 Jun 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
- 181 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
- NCT06376409
- Sponsor's protocol ID
- NW-HGN-02
- Status last verified
- Jul 2025
- First submitted
- 11 Apr 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dang R, Sivamani RK, Hazan A, Raymond I. A 6-Month Prospective, Open-Label, Randomized Study Showing Increased Hair Growth Rate in Women Using Multi-Targeting Hair Growth Nutraceuticals. Dermatol Ther (Heidelb). 2026 Jul 14. doi: 10.1007/s13555-026-01866-z. Online ahead of print.
PubMed 42449043
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective Study of Nutraceutical Supplements to Support Hair Growth in Females With Self-Perceived Thinning Hair
- ClinicalTrials.gov ID
- NCT06376409
- Acronym / sponsor ID
- NW-HGN-02
- Conditions
- Hair Thinning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Nutraceutical Wellness Inc.Industry (pharma, biotech, devices)
- Study start
- 6 May 2024 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 19 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 site open label interventional study evaluating currently marketed hair supplements targeting the underlying root causes of thinning hair.
Detailed description
A single site open label interventional study evaluating currently marketed hair supplements targeting the underlying root causes of thinning hair. All treatment regimens are commercially available nutraceutical hair growth supplements. 45 subjects will be enrolled into each of the 4 supplement groups. Subjects will undergo a baseline, baseline + 48 hours, 90 day, 90 day + 48 hours, 180 day and 180 day + 48 hours visit and will have compliance phone calls at Days 45 and 135. All subject data will be compared to baseline in paired comparison for each subject using a historical control.
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 Supplement, 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 Supplement4 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
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Females of all Fitzpatrick skin, and hair types between 18-70 years of age with self-perceived thinning, confirmed by a dermatologist.
- Willing and able to adhere to the same dietary lifestyles for the duration of the study.
- Able to understand and sign an informed consent agreement and photo release form approved by the Institutional Review Board
- General good health, as determined by the Investigator or qualified sub-investigator.
- Willing and able to attend all study visits and comply with the test product daily instructions.
Key exclusion criteria (18 listed)
- Individuals who are pregnant, planning a pregnancy, nursing, or within 1-year post-partum.
- Individuals who have experienced serious complications due to COVID-19 previously or during the study as determined by the investigator.
- Clinical diagnosis of hair loss disorder such as alopecia areata, or scarring forms of alopecia.
- Individuals who have had a history of any acute or chronic disease that could interfere with or increase the risk on study participation.
- Individuals who have had a history of any acute or chronic medical or hair condition that could affect study results, such as a history of disordered eating.
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 SupplementHair 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 |
Primary outcome
The percent change in hair growth rate at Day 180 relative to baseline (Day 0)
Time frame: 180 days
The percent change in hair growth rate at Day 180 relative to baseline (Day 0) using Canfield HairMetrix® non-invasive device.
15 secondary outcomes
The percent change in hair growth rate at Day 90 relative to baseline (Day 0)
Time frame: 90 Days
The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 90 days
Time frame: 90 days
The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 180 days
Time frame: 180 days
The change in terminal to vellus ratio
Time frame: 90 Days
The change in terminal to vellus ratio
Time frame: 180 Days
The change in anagen to telogen ratio
Time frame: 90 Days
The change in anagen to telogen ratio
Time frame: 180 Days
The change in average number of hairs per follicular unit
Time frame: 90 Days
The change in average number of hairs per follicular unit
Time frame: 180 Days
The change in total hair width per cm2
Time frame: 90 Days
The change in total hair width per cm2
Time frame: 180 Days
The change in mean inter-follicular distance
Time frame: 90 Days
The change in mean inter-follicular distance
Time frame: 180 Days
Subjective assessments of change measured with Consumer Perception Questionnaire at 90 days
Time frame: 90 Days
Subjective assessments of change measured with Consumer Perception Questionnaire at 180 days
Time frame: 180 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 9 Jul 2025.
- Derived from this study: PubMed 42449043Dang R, Sivamani RK, Hazan A, Raymond I. A 6-Month Prospective, Open-Label, Randomized Study Showing Increased Hair Growth Rate in Women Using Multi-Targeting Hair Growth Nutraceuticals. Dermatol Ther (Heidelb). 2026 Jul 14. doi: 10.1007/s13555-026-01866-z. Online ahead of print.
- 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 Supplement, 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 8 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 9 Jul 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?
The percent change in hair growth rate at Day 180 relative to baseline (Day 0) (time frame: 180 days). 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 NCT06376409, 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 9 Jul 2025.