Topical TDM-105795 for Male Pattern Baldness

No longer recruiting at 15 trial locations

Overseen By Zengquan Wang, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Phase 2

Sponsor: Technoderma Medicines Inc.

Must not be taking: Minoxidil, Finasteride, Corticosteroids, others

Disqualifiers: Scalp disorders, HIV, Hepatitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 16 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, to determine its effectiveness for male pattern baldness, specifically in men with mild to moderate hair thinning on the temples and crown. The study compares two strengths of the solution against a placebo (a substance with no active drug) to assess its efficacy and safety. Ideal participants are men who have noticed hair thinning in these areas and have not recently used other hair growth treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications that affect hair growth, like minoxidil, hormone therapy, and some others, for a specific period before starting the study. If you're taking any medications that might affect hair growth, you should discuss them with the study team to see if they need to be stopped.

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

Previous studies have shown promising safety results for TDM-105795. Research indicates that participants tolerated both lower and higher doses of this skin solution well. No major safety concerns were reported, meaning users did not experience serious side effects. TDM-105795 acts like thyroid hormones and can aid hair growth, potentially offering advantages over other treatments. Notably, this treatment has already been tested in humans, providing some reassurance about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for male pattern baldness, which often involve oral medications like finasteride or topical solutions such as minoxidil, TDM-105795 is a new topical solution that researchers are excited about because it offers a potentially novel mechanism of action. Its unique formulation, available in different concentrations (0.0025% and 0.02%), might target hair growth pathways in ways existing treatments do not. This could mean a reduced risk of systemic side effects associated with oral medications and possibly more effective results for patients who haven't responded well to current options.

What evidence suggests that TDM-105795 might be an effective treatment for male pattern baldness?

Research shows that TDM-105795 has promising results for treating male pattern baldness, also known as androgenetic alopecia. Earlier studies found that people using a higher dose of TDM-105795 grew an average of 24.3 more hairs in the treated area. This suggests the treatment might help hair regrow in areas with hair loss. In this trial, participants will receive either a 0.0025% or 0.02% dose of TDM-105795 topical solution, or a placebo. TDM-105795 is a small drug applied directly to the scalp to encourage hair growth. While current results are encouraging, more research is needed to confirm its long-term safety and effectiveness. ^{3 4 6 7 8}

Who Is on the Research Team?

Daniel J. Piacquadio, M.D.

Principal Investigator

Therapeutics Incorporated

Are You a Good Fit for This Trial?

This trial is for males aged 18-55 with mild to moderate male pattern baldness, specifically in the temple and vertex regions. Participants must be in good health with normal kidney, thyroid, and liver function. They should not smoke or use nicotine products and agree to maintain their hair style and color throughout the study. Sexually active participants must use birth control.

Inclusion Criteria

I have mild to moderate hair loss on the top and sides of my head.

My kidney, liver, and thyroid functions are normal according to my recent tests.

Subjects who are sexually active with a female partner and are not surgically sterile (vasectomy performed at least 6 months prior to treatment) must agree to refrain from sperm donation for at least 90 days after administration of their last dose of IP and inform their non-pregnant female sexual partner to use a highly effective form of birth control as described in the informed consent form. Note: Female partner must be confirmed according to subject to be non-pregnant at Visit 1/Screening and Visit 2/Baseline or at the visit when a subject identifies a new sexual partner

Exclusion Criteria

Subject has a history of prescription drug abuse, or illicit drug use within 6 months prior to Visit 1/Screening

I haven't used any hair growth products like Aminexil or Nioxin in the last 4 weeks.

I have experienced hair loss due to conditions other than male/female pattern baldness.

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 daily doses of TDM-105795 or placebo for 16 weeks

16 weeks

6 visits (in-person) at day 1, week 2, week 4, week 8, week 12, and week 16

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• TDM-105795

Trial Overview The study tests TDM-105795 at different concentrations (0.0025%, 0.02%) against a placebo solution for treating male pattern baldness. It's randomized, meaning subjects are assigned treatment by chance; double-blind, so neither researchers nor participants know who gets what; vehicle-controlled comparing an inactive substance; parallel group where each group receives one treatment.

How Is the Trial Designed?

Group I: TDM-105795 topical solution, 0.02% Experimental Treatment 1 Intervention

Daily dose of 0.02% of TDM-105795 topical solution

Group II: TDM-105795 topical solution, 0.0025% Experimental Treatment 1 Intervention

Daily dose of 0.0025% of TDM-105795 topical solution

Group III: TDM-105795 topical vehicle solution Placebo Group 1 Intervention

Daily dose of placebo for TDM-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+

Published Research Related to This Trial

In a randomized double-blind trial involving 56 patients with hereditary male pattern baldness, topical minoxidil therapy resulted in cosmetically acceptable hair growth in 32% of participants.

The study found that factors such as the initial number of indeterminate hairs, the duration of baldness, and the size of the balding area were significant indicators of hair regrowth, with no serious side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical minoxidil therapy in hereditary androgenetic alopecia. De Villez, RL.[2019]

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 ... Subject has a clinical diagnosis of mild to moderate androgenetic alopecia (AGA) in temple and vertex region with a score of IIIv, IV, or V on the Modified ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12026576/

Recent Advances in Drug Development for Hair Loss - PMC A Phase 2a clinical trial involving mild to moderate AGA proved efficacy of TDM-105795.

4. 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- ... TDM-105795 is a small molecule drug candidate being developed as a topical drug for treatment of Androgenetic Alopecia.

5. withpower.com withpower.com/trial/phase-2-alopecia-3-2023-6dc2e

Topical TDM-105795 for Male Pattern Baldness While there is no direct data on TDM-105795, similar treatments like topical minoxidil have shown effectiveness in promoting hair growth in male pattern ...

6. firstwordpharma.com firstwordpharma.com/story/5729288

Technoderma Medicines Initiates TDM-105795 ... As a potent thyromimetic, it may offer significant advantages regarding efficacy and safety compared to existing treatments.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04913519

A Phase 1 Study of TDM-105795 Topical Solution in Male ... The assigned test article will be applied once onto the scalp in the hair loss area (e.g., top of head and temple areas). All subjects will be treated with 1 mL ...

8. synapse.patsnap.com synapse.patsnap.com/article/tdm-105795-phase-2-success-stimulates-hair-growth-in-pattern-baldness

TDM-105795 Phase 2 Success: Stimulates Hair Growth in ... Both strengths were found to be well-tolerated, with no significant safety concerns. Dr. Arthur P. Bertolino, Technoderma's Chief Medical ...