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Recruiting Phase 3 NCT07435012

NCT07435012 Androgenic Alopecia TH07 Clinical Trial

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Clinical Trial Summary
NCT ID NCT07435012
Status Recruiting
Phase Phase 3
Sponsor Triple Hair Inc
Condition Androgenic Alopecia
Study Type INTERVENTIONAL
Enrollment 420 participants
Start Date 2026-04
Primary Completion 2027-12

Eligibility & Interventions

Sex Male only
Min Age 18 Years
Max Age 49 Years
Study Type INTERVENTIONAL
Interventions
TH07TH07Minoxidil 5% Topical Solution

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 420 participants in total. It began in 2026-04 with a primary completion date of 2027-12.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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.

Eligibility 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.

Contact & Investigator

Central Contact

Edouard AL-Chami

✉ ealchami@triplehair.ca

📞 647-453-3253

Frequently Asked Questions

Who can join the NCT07435012 clinical trial?

This trial is open to male participants only, aged 18 Years or older, up to 49 Years, studying Androgenic Alopecia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT07435012 trial and what does that mean for participants?

Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 420 participants.

Is NCT07435012 currently recruiting?

Yes, NCT07435012 is actively recruiting participants. Contact the research team at ealchami@triplehair.ca for enrollment information.

Where is the NCT07435012 trial being conducted?

This trial is being conducted at Vancouver, Canada.

Who is sponsoring the NCT07435012 clinical trial?

NCT07435012 is sponsored by Triple Hair Inc. The trial plans to enroll 420 participants.

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