Androgenic Alopecia TH07 Clinical Trial

NCT07435012 | Recruiting Phase 3

• 1 other identifier: TH0701
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenic Alopecia

Keywords

Hair Loss; Hair growth; Androgenic Alopecia; Balding

Outcome Measures

Primary Outcomes (1)

• Non-vellus hair count

  Number of hair in the matched target area measured by phototrichogram

  Baseline and week 24

Secondary Outcomes (4)

• Hair diameter and cumulative hair thickness

  Baseline and week 24

• Subject-reported improvement

  week 24

• Non-vellus hair count

  Baseline and week 24

• Incidence of treatment related adverse events.

  through study completion, average 28 weeks

Study Arms (4)

Arm A

EXPERIMENTAL

All participants in Arm A will apply TH07 topical solution twice a day for 24 weeks

Drug: TH07

Arm B

EXPERIMENTAL

All participants in Arm B will apply TH07 topical solution once a day and Placebo topical solution once a day for 24 weeks

Drug: TH07

Arm C

ACTIVE COMPARATOR

All participants in Arm C will apply Minoxidil 5% topical solution twice a day for 24 weeks

Drug: Minoxidil 5% Topical Solution

Arm D

PLACEBO COMPARATOR

All participants in Arm D will apply Placebo topical solution twice a day for 24 weeks

Other: Placebo

Interventions

TH07 DRUG

TH07 (5%Minoxidil, 0.1%Finasteride, 0.03%Latanoprost); topical solution; twice a day

Arm A

Minoxidil 5% Topical Solution DRUG

Minoxidil 5%; topical solution; twice a day

Arm C

Placebo OTHER

Placebo; topical solution; twice a day

Arm D

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Any systemic or topical treatment of any system of medicine (other than trial treatment) for AGA.
• Hair dyes, hair texturizers, relaxers etc.
• Any new vitamins or nutritional supplements that are currently not being administered.
• Tattooing in the trial target area.
• Blood donations.
• OTC hair restorers.
• Do not expose your pregnant partner to your hands/skin where the drug might be present.
• Participation in any other drug or device trials during the course of this trial.
• Note: However, the following shall be permissible:
• 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.

You may not qualify if:

• History of scalp treatment including though not limited to any of the following:
• Hair transplant or extension surgery.
• Hair weaving.
• Laser or light therapy on the scalp in the last 6 months.
• Micro-needling or intradermal therapy (mesotherapy) on the scalp including PRP in the last 6 months.
• Any other surgical treatment for hair loss
• Any of the following hair styles:
• 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.

Sponsors & Collaborators

• Triple Hair Inc: lead

Study Sites (1)

YVR Aesthetic Training and Study Centre.

Vancouver, British Columbia, V5Z1H2, Canada

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil; Solutions

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pharmaceutical Preparations

Central Study Contacts

Edouard AL-Chami

CONTACT

647-453-3253; ealchami@triplehair.ca

Lori Hebert

CONTACT

lhebert@triplehair.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)