Phase III, Parallel Design, Triple-Blind, Randomized, Multicenter Clinical Trial to Evaluate Safety & Efficacy of TH07 Topical Treatment in Male Patients With Androgenic Alopecia.
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.
• 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.
‣ 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.