420 Participants NeededMy employer runs this trial

TH07 + Minoxidil for Male Pattern Baldness

(MATT Trial)

EA
LH
Overseen ByLori Hebert
Age: 18 - 65
Sex: Male
Trial Phase: Phase 3
Sponsor: Triple Hair Inc
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new topical solution called TH07 to determine its effectiveness for male pattern baldness, also known as androgenic alopecia. Participants will use either the TH07 solution, a standard hair growth treatment called Minoxidil 5%, or a placebo (a treatment with no active drug) for 24 weeks. The goal is to identify which treatment most effectively promotes hair growth. Men experiencing male pattern baldness who have not used hair loss treatments in the last 90 days may be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to the potential availability of a new treatment.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop any systemic or topical treatments for hair loss that you are currently using, as well as avoid starting any new vitamins or supplements during the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that TH07 is effective and safe in animals and early human studies for treating androgenic alopecia, a type of hair loss. Participants in these studies generally tolerated the treatment well. Reports indicate that the solution works, and patients are satisfied with the results and the treatment's gentle impact on the body. However, while early results are promising, researchers are still gathering information about long-term safety. Although short-term safety appears favorable, more data is needed to fully understand any long-term effects. Prospective participants can consider this information to feel more confident about the safety of trying TH07.12345

Why do researchers think this study treatment might be promising for male pattern baldness?

Researchers are excited about TH07 for male pattern baldness because it offers a new approach compared to traditional treatments like Minoxidil. Unlike Minoxidil, which stimulates hair growth through vasodilation, TH07 may work through a different mechanism, potentially targeting hair follicles more directly or effectively. This could mean better results for those who haven't seen success with current options. Additionally, the trial explores different application frequencies, which might provide flexibility and improved outcomes for users.

What evidence suggests that this trial's treatments could be effective for male pattern baldness?

Research has shown that TH07, which participants in this trial may receive, may help treat male pattern baldness. In earlier studies, about 82% of people using TH07 experienced positive results, surpassing the typical outcomes seen with minoxidil alone. Many participants expressed satisfaction with their hair's appearance while using TH07. This trial will compare TH07 with minoxidil, another treatment option in this study. These studies have not reported serious side effects from TH07.13467

Are You a Good Fit for This Trial?

This trial is for men aged 18-49 with male pattern baldness (Hamilton Norwood III vertex to V), a BMI between 19 and 35, who haven't used hair loss treatments in the past 90 days. Participants must be willing to follow study rules and have no recent scalp surgeries or severe medical conditions.

Inclusion Criteria

I am a male between 18 and 49 years old.
I have moderate to severe male pattern baldness.
Body Mass Index (BMI) in the range of 19 to 35 kg/m2
See 4 more

Exclusion Criteria

I have used or am likely to use certain specified medicines.
I have been diagnosed with certain medical conditions.
Presence of specific hair styles such as shaved scalp, use of occlusive wig, hair extensions, non-breathable wigs
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply the assigned topical solution daily for 24 weeks

24 weeks
Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • TH07

Trial Overview

The study compares a new topical solution (TH07) with standard Minoxidil 5% and a placebo. Participants apply one of these daily for 24 weeks to see which works best at increasing hair growth.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Arm BExperimental Treatment1 Intervention
Group II: Arm AExperimental Treatment1 Intervention
Group III: Arm CActive Control1 Intervention
Group IV: Arm DPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Triple Hair Inc

Lead Sponsor

Citations

TH07 – A New Novel Topical Treatment for Androgenic Alopecia

However, the efficiency of finasteride was found to vary from 31% to 66% and minoxidil averaged only 38% effectiveness for hair re-growth.[34,36] In addition, ...

TH07-A New Novel Topical Treatment for Androgenic ...

Most of the patients treated with TH07 were satisfied with their hair appearance in comparison to the other treatments. No systemic adverse ...

Triple Hair Doses First Patient in Phase III Clinical Trial ...

The Phase III clinical trial (NCT07435012) is designed to evaluate the safety and efficacy of TH07 in men with androgenic alopecia. TH07 is ...

TH07 Clinical Study Featured in Peer-Reviewed Scientific ...

Most of the patients treated with TH07 were satisfied with their hair appearance in comparison to the other treatments. No systemic adverse ...

Triple Hair Initiates Phase III Trial for TH07 Triple-Combination ...

TH07Search drug has demonstrated encouraging results in earlier clinical studies, with 82% of participants experiencing positive outcomes ...

TH07 Hair Loss Treatment: Research, Side Effects & ...

Longer safety data across a broader population is still needed. ... TH07 is an exciting investigational treatment for male pattern hair loss ...

Androgenic Alopecia TH07 Clinical Trial - ClinicalTrials.Veeva

The MATT study is a Phase III clinical trial designed to evaluate the safety and effectiveness of a new topical hair growth treatment called ...