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 range40 Years – 65 Years
SexMALE
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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.
✓. 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.
What they're measuring
1
Hair Growth Global Improvement Scale rating at 6 months
✕. 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.