TDM-105795 for Male Pattern Baldness

No longer recruiting at 1 trial location

Overseen By Zengquan Wang, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Technoderma Medicines Inc.

Must not be taking: CYP3A4 inhibitors, Systemic medications

Disqualifiers: Scalp disorders, Malignancy, HIV, others

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new topical solution, TDM-105795, for its potential to treat male pattern baldness, also known as Androgenetic Alopecia (AGA). The study aims to determine if the treatment can safely and effectively promote hair growth in men with moderate to severe thinning on the top of their heads. Participants will receive either the actual treatment or a placebo (a substance with no active treatment) to compare results. Ideal candidates are men with noticeable hair loss at the temples and crown, without scalp conditions like infections or eczema. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications before joining the trial. Specifically, you must stop using systemic prescription medications, herbal supplements, and over-the-counter medications within 14 days before the trial starts, except for acetaminophen at less than 3g/day, which is allowed until 24 hours before the trial begins.

Is there any evidence suggesting that TDM-105795 is likely to be safe for humans?

Research has shown that TDM-105795 has been safe for people in studies so far. Earlier research tested different strengths of the TDM-105795 cream. Participants handled these strengths well, and researchers found no major safety issues. This indicates that the treatment did not cause any serious side effects or problems for those in the studies. While the current trial remains in its early stages, existing evidence suggests that TDM-105795 is likely safe for people based on previous trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for androgenetic alopecia, which often include oral medications like finasteride or topical minoxidil, TDM-105795 is a topical solution that acts directly on the affected area. Researchers are particularly excited because TDM-105795 offers a new formulation that targets the hair follicles with varying concentrations, from 0.0025% to 0.02%, potentially increasing its effectiveness. Moreover, as a topical solution, it might minimize systemic side effects that can occur with oral treatments. This approach could provide a more targeted and safer option for individuals experiencing hair loss.

What evidence suggests that TDM-105795 might be an effective treatment for Androgenetic Alopecia?

Research shows that TDM-105795, which participants in this trial may receive, may help treat androgenetic alopecia (AGA), a common type of hair loss. In earlier studies, this topical solution increased the number of thicker, more visible hairs by an average of 24.3 in the treated area. Tests on mice also showed that higher doses of TDM-105795 led to more hair growth. Importantly, the treatment showed little to no absorption into the body, suggesting fewer side effects. These findings indicate that TDM-105795 could be a promising option for those experiencing pattern baldness. ^{2 3 5 6 7}

Who Is on the Research Team?

Daniel Piacquadio, M.D.

Principal Investigator

Therapeutics Incorporated

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject is a non-smoker, defined as not having smoked or used any form of tobacco or non-tobacco products containing nicotine in more than 6 months before Visit 2/Baseline.

Subject has provided written informed consent.

Subject has a clinical diagnosis of moderate to severe AGA in temple and vertex region, III to VI on the Modified Norwood-Hamilton Scale (i.e., III, IV, V, and VI).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive multiple dose administration of TDM-105795 or placebo applied daily to the scalp

6 weeks

4 visits (in-person) on days 1, 8, 15, and 28

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• TDM-105795

How Is the Trial Designed?

Group I: MAD Cohorts 1-4 TDM-105795 topical solution Experimental Treatment 1 Intervention

Multiple dose administration of TDM-105795 Topical Solution, 0.0025% or 0.005% or 0.01% or 0.02%

Group II: Placebo for TDM-105795 topical solution Placebo Group 1 Intervention

Multiple dose administration of Placebo forTDM-105795 Topical Solution

Who Is Running the Clinical Trial?

Technoderma Medicines Inc.

Lead Sponsor

Trials

5

Recruited

220+

Therapeutics, Inc.

Industry Sponsor

Trials

31

Recruited

3,900+

Citations

1.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/technoderma-androgenetic-alopecia-trial/

Technoderma reports data from androgenetic alopecia ...

The results indicated that TDM-105795 led to a mean increase in non-vellus Target Area Hair Count (TAHC) of 24.3 hairs with the high label ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05802173

NCT05802173 | Study of TDM-105795 Following Topical ...

Protocol 239-11651-203 is a Phase 2 study entitled "A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Multi-Dose Study to Evaluate the Efficacy ...

3.

biospace.com

biospace.com/technoderma-medicines-phase-2-clinical-trial-of-tdm-105795-demonstrates-hair-growth-in-androgenetic-alopecia

Technoderma Medicines Phase 2 Clinical Trial of TDM- ...

Moreover, in vivo efficacy studies in C3H mice showed that TDM-105795 was able to potently stimulate hair growth in a dose-dependent manner when ...

4.

synapse.patsnap.com

synapse.patsnap.com/blog/technodermas-tdm-105795-stage-2-trial-shows-positive-hair-regrowth-in-pattern-baldness

Technoderma's TDM-105795 Stage 2 Trial Shows Positive ...

The Stage 2 trial for Technoderma's drug, TDM-105795, reveals positive outcomes for hair regeneration in individuals with pattern baldness.

5.

dermnppa.org

dermnppa.org/novel-topical-shows-promise-for-androgenetic-alopecia-in-phase-2a/

Novel Topical Shows Promise for Androgenetic Alopecia in ...

TDM-105795 was applied once-daily. Bioanalytical results show extremely low to no systemic exposure. Technoderma says it looks forward to moving ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04913519

A Phase 1 Study of TDM-105795 Topical Solution in Male ...

Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... Single dose administration of TDM-105795 Topical Solution, 0.0025% or 0.005% or 0.01%.

7.

firstwordpharma.com

firstwordpharma.com/story/5729288

Technoderma Medicines Initiates TDM-105795 ...

Study objectives are to evaluate efficacy, safety and pharmacokinetics of topical TDM-105795. Approximately 12 U.S. clinical sites are currently ...