TH07 topical treatment for male pattern hair loss
Phase III, Parallel Design, Triple-Blind, Randomized, Multicenter Clinical Trial to Evaluate Safety & Efficacy of TH07 Topical Treatment in Male Patients With Androgenic Alopecia.
This trial will test whether a new daily topical spray called TH07 helps men aged 18–49 with male pattern hair loss grow more hair than standard minoxidil or a placebo over 24 weeks.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Male |
| Sponsor | Triple Hair Inc Industry-sponsored |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT07435012 on ClinicalTrials.gov |
What this trial studies
This Phase 3, randomized trial will enroll up to 420 men with androgenic alopecia (Hamilton-Norwood III vertex to V) across clinical sites, with participants assigned to one of four arms: TH07 once daily, TH07 twice daily, standard 5% minoxidil, or placebo. TH07 is a combined topical spray containing minoxidil 5%, finasteride 0.1%, and latanoprost 0.03%. Participants will apply the assigned product for 24 weeks while being monitored for hair count changes and safety outcomes. The primary comparison is change in hair count between groups at the end of treatment, with regular clinic visits to document efficacy and adverse events.
Who should consider this trial
Good fit: Men aged 18–49 with androgenic alopecia classified as Hamilton-Norwood III vertex to V, BMI 19–35 kg/m2, not having used systemic or topical AGA treatments in the prior 90 days, and willing to follow study restrictions are eligible.
Not a fit: Women, men outside the 18–49 age range, those with other forms of hair loss or very advanced baldness outside Norwood III–V, or recent users of hair-loss treatments are unlikely to qualify or benefit from this study.
Why it matters
Potential benefit: If successful, TH07 could produce greater hair regrowth than standard minoxidil alone while delivering treatment topically to limit systemic exposure.
How similar studies have performed: Previous trials of topical minoxidil combined with topical finasteride have shown positive effects on hair growth, but the three-way combination including latanoprost is relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Males, 18 to 49 years of age on the date of enrollment.
* Presenting with androgenic alopecia measured as III vertex to V on Hamilton Norwood Scale.
* Body Mass Index (BMI) in the range of 19 to 35 kg/m2.
* Not administered any systemic or topical treatment for AGA during the last 90 days.
* Willing to comply with the following restrictions for the duration of trial participation:
1. Any systemic or topical treatment of any system of medicine (other than trial treatment) for AGA.
2. Hair dyes, hair texturizers, relaxers etc.
3. Any new vitamins or nutritional supplements that are currently not being administered.
4. Tattooing in the trial target area.
5. Blood donations.
6. OTC hair restorers.
7. Do not expose your pregnant partner to your hands/skin where the drug might be present.
8. Participation in any other drug or device trials during the course of this trial.
Note: However, the following shall be permissible:
9. Non-medicated \& anti-dandruff shampoos, scalp/hair applications including styling gels, sprays, mousse (styling gels, sprays, mousse etc. not to be used on the days of trial visits to the clinic.
10. Current regimen (if any) of vitamins and nutritional supplements.
* Willing and able to provide written informed consent for participation in the trial and to comply with all trial requirements.
* Availability of and usage familiarity with a personal mobile phone (Android or iOS) with internet connectivity and a personal email address.
Exclusion Criteria:
* History of scalp treatment including though not limited to any of the following:
1. Hair transplant or extension surgery.
2. Hair weaving.
3. Laser or light therapy on the scalp in the last 6 months.
4. Micro-needling or intradermal therapy (mesotherapy) on the scalp including PRP in the last 6 months.
5-Any other surgical treatment for hair loss
* Any of the following hair styles:
1.Shaved scalp. 2-Use of occlusive wig, hair extensions, non- breathable wigs.
* Known or presumed hypersensitivity to any trial treatment medication; history of anaphylaxis to drugs or allergic reactions in general, which in the opinion of investigator may affect the outcome of trial.
* Any other significant abnormalities indicating of severe, acute or chronic medical condition(s) that may lead to hair loss or otherwise interfere with the interpretation of trial results.
* History or likelihood of use of any of the specified medicines.
* History or clinical diagnosis of any of the specified medical conditions.
* Participation in any investigational or marketed drug or device trial in the last 90 days prior to screening for this trial.
* Any other condition that in the opinion of the investigator makes the patient unsuitable for inclusion in the trial.
Where this trial is running
Vancouver, British Columbia
- YVR Aesthetic Training and Study Centre. — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Edouard AL-Chami
- Email: ealchami@triplehair.ca
- Phone: 647-453-3253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.