A Safety and Efficacy Study of a Nutraceutical in Aging Males With Thinning Hair (NCT06854575) | Clinical Trial Compass
TerminatedNot Applicable
A Safety and Efficacy Study of a Nutraceutical in Aging Males With Thinning Hair
Stopped: Sponsor Business Decision
United States155 participantsStarted 2025-03-10
Plain-language summary
A study to assess the safety and efficacy of a dietary supplement when used over the course of 9 months by men with self-perceived hair thinning.
Who can participate
Age range
40 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male, 40 to 65 years of age.
. In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.
. Having Fitzpatrick skin type I-IV.
. Having overall hair thinning (diffuse thinning of the top of the crown or at temples and/or widening part or receding hair line) confirmed by the study dermatologist at baseline (grade III, IIIa, III vertex, IV, or IVa on the Hamilton-Norwood scale).
. With self-perceived thinning hair on the scalp.
. Willing to participate in the Hair Pull Test, in which a trained practitioner will grasp a 4-6mm bundle of hair near the scalp and firmly tug the hair.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hair Growth Global Improvement Scale rating at 6 months
. Having a regular mild, non-medicated shampoo and conditioner (if used) and willing to bring the product(s) in to the first clinic visit for documentation and to continue using the product(s) for the duration of the study.
. Willing to continue using regularly used hair styling products (mousse, hairspray) if used, and not start using any new hair products for the duration of the study.
Exclusion criteria
. Having a pregnant partner or a partner that is planning to become pregnant during the study.
. Having a known allergy to any ingredients in the test products.
. Having a history of skin cancer within the past 5 years.
. Having hair extensions, hair weave, tight braids, crew cut, or very short hair (less than 1.5 inches in length).
. Having started any new vitamin, mineral, or herbal supplement within 30 days prior to baseline.
. Smokers with usage \>20 cigarettes/day.
. Who have been diagnosed with hair loss disorders such as alopecia areata, scarring alopecia, traction alopecia, chemical alopecia, trichotillomania or trichorrhexis nodosa, or suffering from moderate to severe hair loss disorder (grade V-VII on the Hamilton-Norwood scale) confirmed by the investigator.
. Having hair loss due to disease, injury, or medical therapy.