The goal of this clinical trial is to learn whether a new topical solution, TH07, can help treat androgenic alopecia in men and to learn more about its safety. Participants will be asked to apply either the TH07 solution, a standard hair growth treatment (Minoxidil 5%), or a placebo every day for 24 weeks. At the end of the study, hair growth will be compared in each group to determine which treatment is most effective at increasing hair count.
The MATT study is a Phase III clinical trial designed to evaluate the safety and effectiveness of a new topical hair growth treatment called TH07. TH07 is a combined topical spray solution containing three active ingredients commonly used to treat hair loss: Minoxidil (5%) Finasteride (0.1%) and Latanoprost (0.03%). The study plans to enroll 420 men aged 18 to 49 years old across up to 10 clinical sites. Participants will be randomly assigned to one of four groups to receive either TH07 (once or twice daily), a standard Minoxidil solution, or a placebo. The treatment will be applied daily (once or twice) for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
420
YVR Aesthetic Training and Study Centre.
Vancouver, British Columbia, Canada
RECRUITINGNon-vellus hair count
Number of hair in the matched target area measured by phototrichogram
Time frame: Baseline and week 24
Hair diameter and cumulative hair thickness
hair thickness is defined as average hair diameter \* hair count in the matched target area / size of matched target area (mm/cm2)
Time frame: Baseline and week 24
Subject-reported improvement
self-assessment questionnaire
Time frame: week 24
Non-vellus hair count
in the matched target area by phototrichogram between TH07 twice daily, TH07 once daily, and placebo
Time frame: Baseline and week 24
Incidence of treatment related adverse events.
reporting of adverse events and serious adverse events
Time frame: through study completion, average 28 weeks
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Placebo; topical solution; twice a day