Topical TDM-105795 for Male Pattern Baldness

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

71 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called TDM-105795 to see if it can help men with a common type of hair loss. The study will compare different doses of the treatment over several months.

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.

What data supports the effectiveness of the drug 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 baldness, with significant changes in hair counts and cosmetically acceptable results in some patients. ^{1 2 3 4 5}

Research Team

Daniel J. Piacquadio, M.D.

Principal Investigator

Therapeutics Incorporated

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

New topical agents for hair growth. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Topical minoxidil therapy in hereditary androgenetic alopecia. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Dutasteride improves male pattern hair loss in a randomized study in identical twins. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Androgenetic alopecia treated with topical minoxidil. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Emerging Therapies for Androgenetic Alopecia. [2015]