Prospective Study of Nutraceutical Supplements to Support Hair Growth in Females

NCT06376409 | Completed

• 1 other identifier: NW-HGN-02
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

Brief Summary

A single site open label interventional study evaluating currently marketed hair supplements targeting the underlying root causes of thinning hair.

Conditions

Hair Thinning

Outcome Measures

Primary Outcomes (1)

• 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.

  180 days

Secondary Outcomes (15)

• The percent change in hair growth rate at Day 90 relative to baseline (Day 0)

  90 Days

• The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 90 days

  90 days

• The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 180 days

  180 days

• The change in terminal to vellus ratio

  90 Days

• The change in terminal to vellus ratio

  180 Days

Study Arms (1)

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.

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

Interventions

Nutrafol Women's Hair Growth Supplement DIETARY_SUPPLEMENT

Hair growth supplement for women ages 18 - 44

Nutrafol Hair Growth Supplement

Nutrafol Women's Balance Hair Growth Supplement DIETARY_SUPPLEMENT

Hair growth supplement for women ages 45 - 70

Nutrafol Hair Growth Supplement

Nutrafol Women's Vegan Hair Growth Supplement DIETARY_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 Hair Growth Supplement

Nutrafol Women's Postpartum Hair Growth Supplement DIETARY_SUPPLEMENT

Hair growth supplement for women ages 18 - 44. This product will be studied in the general women population and not postpartum women.

Nutrafol Hair Growth Supplement

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Nutraceutical Wellness Inc.: lead

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment 6-month, single-center, prospective interventional study

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 19, 2024
• Study Start: May 6, 2024
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)