NCT06362941

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Nutraceutical Wellness Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hair Thinning

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutrafol Women's Hair Growth Supplemnt	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.
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 Men's Hair Growth Supplement	Hair growth supplement for men ages 25 - 50.

Timeline

• Start date: 2024-05-20
• Primary completion: 2025-02-18
• Completion: 2025-02-18
• First posted: 2024-04-12
• Last updated: 2025-03-11

Locations

1 site across 1 country: United States