Evaluation of an Oral Hair Supplement to Improve Hair Strength and Support Growth in Women and Men
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
1 other identifier
interventional
250
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2024
CompletedFirst Posted
Study publicly available on registry
April 12, 2024
CompletedStudy Start
First participant enrolled
May 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2025
CompletedMarch 11, 2025
September 1, 2024
9 months
April 8, 2024
March 6, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
90 days
Secondary Outcomes (8)
Change in broken hairs recovered from the hair pull test compared to baseline at Day 180
180 days
Change in broken hairs recovered from the hair pull test compared to baseline at Day 90
90 days
Change in hair breakage during the hair pull test compared to baseline at Day 180
180 Days
Change in hair breakage during the hair pull test compared to baseline at Day 90
90 Days
Change in the number of hairs recovered from the hair pull test compared to baseline at Day 180
180 Days
- +3 more secondary outcomes
Study Arms (1)
Nutrafol Hair Growth Supplement
EXPERIMENTAL5 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.
Interventions
Hair growth supplement for women ages 18 - 44.
Hair growth supplement for women ages 45 - 70.
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.
Hair growth supplement for women ages 18 - 44. This product will be studied in the general women population and not postpartum women.
Hair growth supplement for men ages 25 - 50.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dermatology Consulting Services
High Point, North Carolina, 27262, United States
Related Publications (1)
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). 2025 Oct 31. doi: 10.1007/s13555-025-01582-0. Online ahead of print.
PMID: 41171588DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2024
First Posted
April 12, 2024
Study Start
May 20, 2024
Primary Completion
February 18, 2025
Study Completion
February 18, 2025
Last Updated
March 11, 2025
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share