Prospective Study of Nutraceutical Supplements to Support Hair Growth in Females

July 7, 2025 updated by: Nutraceutical Wellness Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
181

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95815
        • Integrative Skin Science and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Females of all Fitzpatrick skin, and hair types between 18-70 years of age with self-perceived thinning, confirmed by a dermatologist.
  2. Willing and able to adhere to the same dietary lifestyles for the duration of the study.
  3. Able to understand and sign an informed consent agreement and photo release form approved by the Institutional Review Board
  4. General good health, as determined by the Investigator or qualified sub-investigator.
  5. Willing and able to attend all study visits and comply with the test product daily instructions.
  6. 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).
  7. Willing and able to cooperate with the requirements of the study.
  8. Able to complete and understand the various questionnaires.

Exclusion Criteria:

  1. Individuals who are pregnant, planning a pregnancy, nursing, or within 1-year post-partum.
  2. Individuals who have experienced serious complications due to COVID-19 previously or during the study as determined by the investigator.
  3. Clinical diagnosis of hair loss disorder such as alopecia areata, or scarring forms of alopecia.
  4. Individuals who have had a history of any acute or chronic disease that could interfere with or increase the risk on study participation.
  5. 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.
  6. Scalp hair loss on the treatment area, due to disease, injury, or medical therapy.
  7. 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.
  8. History of surgical correction of hair loss on the scalp (i.e., hair transplant).
  9. 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.
  10. 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).
  11. History of malignancy (except cutaneous squamous cell carcinoma and basal cell carcinoma) or currently undergoing chemotherapy or radiation treatments.
  12. 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.
  13. 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.
  14. A known allergy to any of the ingredients in the investigational product.
  15. Utilization of low-level lasers for hair growth in the last three months.
  16. Any condition that the Investigator thinks may put the subject at risk or interfere with their participation in the study or study results.
  17. 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.
  18. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nutrafol Hair Growth Supplement
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.
Dietary supplement: Nutrafol Women's Postpartum Hair Growth Supplement
Hair growth supplement for women ages 18 - 44. This product will be studied in the general women population and not postpartum women.
Dietary supplement: Nutrafol Women's Hair Growth Supplement
Hair growth supplement for women ages 18 - 44
Dietary supplement: Nutrafol Women's Balance Hair Growth Supplement
Hair growth supplement for women ages 45 - 70
Dietary supplement: Nutrafol Women's Vegan Hair Growth 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
180 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The percent change in hair growth rate at Day 90 relative to baseline (Day 0)
Time Frame: 90 Days
The percent change in hair growth rate at Day 90 relative to baseline (Day 0) as measured by the Canfield HairMetrix®.
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 90 days as measured by the Canfield HairMetrix® compared to baseline.
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 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.
180 days
The change in terminal to vellus ratio
Time Frame: 90 Days
The change in terminal to vellus ratio as measured by the Canfield HairMetrix® at 90 days compared to baseline.
90 Days
The change in terminal to vellus ratio
Time Frame: 180 Days
The change in terminal to vellus ratio as measured by the Canfield HairMetrix® at 180 days compared to baseline.
180 Days
The change in anagen to telogen ratio
Time Frame: 90 Days
The change in terminal to vellus ratio per cm2 as measured by the Canfield HairMetrix® at 90 days compared to baseline.
90 Days
The change in anagen to telogen ratio
Time Frame: 180 Days
The change in terminal to vellus ratio per cm2 as measured by the Canfield HairMetrix® at 180 days compared to baseline.
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 as measured by the Canfield HairMetrix® at 90 days compared to baseline.
90 Days
The change in average number of hairs per follicular unit
Time Frame: 180 Days
The change in average number of hairs per follicular unit as measured by the Canfield HairMetrix® at 180 days compared to baseline.
180 Days
The change in total hair width per cm2
Time Frame: 90 Days
The change in total hair width per cm2 as measured by the Canfield HairMetrix® at 90 days compared to baseline.
90 Days
The change in total hair width per cm2
Time Frame: 180 Days
The change in total hair width per cm2 as measured by the Canfield HairMetrix® at 180 days compared to baseline.
180 Days
The change in mean inter-follicular distance
Time Frame: 90 Days
The change in mean inter-follicular distance as measured by the Canfield HairMetrix® at 90 days compared to baseline.
90 Days
The change in mean inter-follicular distance
Time Frame: 180 Days
The change in mean inter-follicular distance as measured by the Canfield HairMetrix® at 180 days compared to baseline.
180 Days
Subjective assessments of change measured with Consumer Perception Questionnaire at 90 days
Time Frame: 90 Days
Subjective assessments of change in hair growth and appearance measured with Consumer Perception Questionnaire at 90 days
90 Days
Subjective assessments of change measured with Consumer Perception Questionnaire at 180 days
Time Frame: 180 Days
Subjective assessments of change in hair growth and appearance measured with Consumer Perception Questionnaire at 180 days
180 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nutraceutical Wellness Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 18, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NW-HGN-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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