Evaluation of an Oral Hair Supplement to Improve Hair Strength and Support Growth in Women and Men

Hair Thinning Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06362941
• Other study ID #: NW-HGN-01
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: May 2024
• Source: Nutraceutical Wellness Inc.
• Contact: Emily Hu
• Phone: 1-888-508-3471
• Email: emily.hu[@]nutrafol.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 30, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Female or male subjects with concerns and/or signs of hair thinning.

2. The subjects must meet the age characteristics based on their supplement group assignment.

3. Subjects are Fitzpatrick Skin Types I to VI.

4. Subjects must be in good general health.

5. Subjects must be classified with thinning hair by the study dermatologist.

6. 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.

7. 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).

8. Willing and able to adhere to the same dietary lifestyles for the duration of the study

9. Subjects must express willingness to cooperate with the investigator and comply to study requirements.

10. Subjects must demonstrate the ability to read and understand all the items in the informed consent document.

11. Subjects must agree not to use any other hair supplements or start a new vitamin supplement during the study.

12. Subject has signed an Informed Consent Form in compliance with 21CFR Part 50:

"Protection of Human Subjects."

13. Subject is dependable and able to follow directions and is willing to comply with the schedule of visits.

Exclusion Criteria:

1. 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.

2. Subjects possessing signs of severe female or male pattern hair loss or alopecia (including androgenetic and traction alopecia) as determined by the study dermatologist.

3. Scalp hair loss on the treatment area, due to disease, injury, or medical therapy

4. Subjects who are not willing to use only the assigned oral study supplement and no new oral supplements during the study.

5. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study product.

6. Subjects, who are pregnant, breast feeding, or planning a pregnancy.

7. Subjects with clinically significant unstable medical disorders.

8. Subjects who are unwilling or unable to comply with the requirements of the protocol.

9. 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.

10. Subjects with any planned surgeries and/or invasive medical procedures during the course of the study.

11. History of surgical correction of hair loss on the scalp (i.e., hair transplant).

12. 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.

13. 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

14. 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).

15. History of burning, flaking, itching, and stinging of the scalp.

16. Utilization of low-level lasers for hair growth in the last three months.

17. 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.

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Hair Thinning
• Hypotrichosis

Intervention

Dietary Supplement:
• Nutrafol Women's Hair Growth Supplemnt
Hair growth supplement for women ages 18 - 44.
• Nutrafol Women's Balance Hair Growth Supplement
Hair growth supplement for women ages 45 - 70.
• 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.
• 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.
• Nutrafol Men's Hair Growth Supplement
Hair growth supplement for men ages 25 - 50.

Locations

Country	Name	City	State
United States	Dermatology Consulting Services	High Point	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Nutraceutical Wellness Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	180 days
Secondary	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.	90 days
Secondary	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.	180 Days
Secondary	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.	90 Days
Secondary	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.	180 Days
Secondary	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.	90 Days
Secondary	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.	180 Days
Secondary	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.	90 Days