What side effects are associated with this type of intervention?

The most common treatments for male pattern baldness include minoxidil, finasteride, and dutasteride. Minoxidil, a topical treatment, can cause side effects such as scalp irritation, itching, and unwanted facial hair growth. Finasteride and dutasteride, both oral medications, may lead to sexual side effects like decreased libido, erectile dysfunction, and ejaculation disorders. Additionally, finasteride has been associated with a risk of depression. These treatments aim to promote hair growth or prevent further hair loss.

What other types of research exist?

Promising novel alternatives to TDM-105795 for male pattern baldness include: 1) Oral minoxidil, which has shown efficacy in combination with tofacitinib for severe alopecia areata. 2) Janus kinase (JAK) inhibitors like ruxolitinib and tofacitinib, which have demonstrated hair regrowth in alopecia areata patients. 3) Platelet-rich plasma (PRP) therapy, which has been reviewed for its potential in treating alopecia areata. 4) 308-nm excimer laser therapy, which has been effective in treating alopecia areata in both adults and children.

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Topical TDM-105795 for Male Pattern Baldness

Q: What prior FDA approvals exist?

The FDA has approved two primary treatments for male pattern baldness: minoxidil and finasteride. Minoxidil is a topical solution that promotes hair growth and is available over-the-counter in 2% and 5% formulations. Finasteride is an oral medication that prevents hair loss by inhibiting the conversion of testosterone to dihydrotestosterone (DHT), a hormone linked to hair loss. Both treatments aim to promote hair growth or prevent further hair loss, similar to the objectives of the trial TDM-105795.

Phase 2

Waitlist Available

Research Sponsored by Technoderma Medicines Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 Norwood-Hamilton Scale

Subject is male, 18-55 years old

Must not have

Subject has history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA

Subject has had radiation of the scalp at any point

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of TDM-105795 are not specified here but could include skin irritation or allergic reactions at the site of application given it's a topical medication being tested on individuals with alopecia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am a man aged between 18 and 55.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have received radiation treatment on my scalp.

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I have cancer, but it's not skin cancer in the area being treated.

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I haven't used any experimental treatments in the last 30 days or 5 half-lives.

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I have used chemotherapy or similar treatments within the last year.

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I do not have any skin conditions on my scalp that could affect the study.

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I have had PRP treatments on my scalp.

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I have been treated with the investigational product before.

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I have had scalp surgery, significant head injury, hair transplants, or weaves.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in non-vellus target area hair count (TAHC)

Evaluation of treatment benefit

Secondary study objectives

Change in non-vellus target area hair darkness (TAHD)

Change in non-vellus target area hair width (TAHW)

Evaluation of investigator's global assessment (IGA) grade

+1 more

Other study objectives

Incidence (severity and causality) of any local and systemic adverse events (AEs)

Number of participants with abnormal BMI

Number of participants with abnormal ECG readings

+11 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: TDM-105795 topical solution, 0.02%Experimental Treatment1 Intervention

Daily dose of 0.02% of TDM-105795 topical solution

Group II: TDM-105795 topical solution, 0.0025%Experimental Treatment1 Intervention

Daily dose of 0.0025% of TDM-105795 topical solution

Group III: TDM-105795 topical vehicle solutionPlacebo Group1 Intervention

Daily dose of placebo for TDM-105795 topical solution

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TDM-105795, 0.0025%

2023

Completed Phase 2

~80

TDM-105795, 0.02%

2023

Completed Phase 2

~80

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Male Pattern Baldness (MPB) include minoxidil and finasteride. Minoxidil is a topical treatment that promotes hair growth by prolonging the anagen phase of hair follicles. Finasteride is an oral medication that prevents hair loss by inhibiting the enzyme 5-alpha reductase, which reduces the levels of dihydrotestosterone (DHT) responsible for hair follicle miniaturization. Emerging treatments like TDM-105795 are being studied for their potential to promote hair growth through novel mechanisms. Understanding these mechanisms is crucial for MPB patients as it helps them make informed decisions about their treatment options, potentially leading to more effective management of their condition.

Platelet-rich plasma for androgenetic alopecia: a pilot study.Efficacy and safety of finasteride therapy for androgenetic alopecia: a systematic review.