Actively Recruiting
Phase III Randomized, Triple-Blind Trial Evaluating TH07 Topical Treatment for Male Androgenic Alopecia
Led by Triple Hair Inc · Updated on 2026-03-16
420
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new topical solution called TH07 for treating androgenic alopecia, or male pattern hair loss, in men aged 18 to 49 years. This Phase III clinical trial aims to assess the safety and effectiveness of TH07, which combines three active ingredients commonly used for hair growth: Minoxidil, Finasteride, and Latanoprost. The study plans to enroll 420 men and compare TH07 to a standard treatment and a placebo over 24 weeks. Participants will be randomly assigned to one of four groups: applying TH07 twice daily, TH07 once daily plus placebo once daily, Minoxidil 5% solution twice daily, or placebo twice daily. All treatments are topical solutions applied daily for 24 weeks. The trial uses a triple-blind, randomized design with multiple sites involved. During the study, participants will have their hair growth measured by counting non-vellus hairs at the start and after 24 weeks. Additional assessments include hair thickness, participant-reported improvement, and monitoring for treatment-related side effects throughout the roughly 28-week study period. Participants must comply with several restrictions and will be monitored regularly to evaluate the treatments' effects on hair growth and safety.
CONDITIONS
Brief Title
Androgenic Alopecia TH07 Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, 18 to 49 years old at enrollment
- Diagnosed with androgenic alopecia rated III vertex to V on Hamilton Norwood Scale
- Body Mass Index between 19 and 35 kg/m2
- No systemic or topical treatment for androgenic alopecia in the last 90 days
- Willing to avoid other hair loss treatments, hair dyes, new vitamins, tattooing in target area, blood donations, and OTC hair restorers during trial
- Willing and able to provide written informed consent
- Has and is familiar with a personal mobile phone with internet and email access
You will not qualify if you...
- History of scalp treatments like hair transplant, hair weaving, laser/light therapy, microneedling, PRP, or other surgical hair loss treatments within last 6 months
- Hair styles including shaved scalp or use of occlusive wigs or hair extensions
- Known or suspected allergy to study medications or history of severe allergic reactions
- Severe, acute, or chronic medical conditions affecting hair loss or study results
- Use or history of specified medicines or medical conditions that may interfere with study
- Participation in other drug or device trials within 90 days prior to screening
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants apply a topical hair growth treatment once or twice daily for androgenic alopecia for 24 weeks.
Regular visits during treatment as scheduled by the study team
Duration - Up to 4 weeks
Participants are monitored for treatment-related adverse events and hair growth outcomes after completing treatment.
1 final visit (in-person) after treatment completion
Trial Site Locations
Total: 1 location
1
YVR Aesthetic Training and Study Centre.
Vancouver, British Columbia, Canada, V5Z1H2
Actively Recruiting
Research Team
E
Edouard AL-Chami
L
Lori Hebert
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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