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Anti-androgen

VDPHL01 for Male Pattern Baldness

Phase 2 & 3

Recruiting

Research Sponsored by Veradermics, Inc.

Eligibility Criteria Checklist

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

Must have

Subject is male aged 18-65 years old

Be older than 18 years old

Must not have

Subject has uncontrolled blood pressure

Subject has symptoms or history of certain heart or thyroid conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6

Summary

This trial will test a new drug, VDPHL01, to treat male pattern baldness. The study will last 13 months and involve 11 visits. Participants will receive either the investigational

Who is the study for?

This trial is for males with Androgenetic Alopecia (male pattern baldness), which is hair loss due to a strong response of hair follicles to hormones. Participants must meet certain health criteria and be available for 11 study visits over approximately 13 months.

What is being tested?

The trial tests VDPHL01, an oral medication aimed at treating male pattern baldness. It's a double-blind study, meaning neither the researchers nor participants know who gets the real drug or placebo during the first part of the trial.

What are the potential side effects?

Since this summary does not provide specific side effects of VDPHL01, it can be assumed that potential side effects will be monitored and reported as part of evaluating the safety and efficacy of the drug.

Eligibility Criteria

Inclusion Criteria

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

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I am a man between 18 and 65 years old.

Exclusion Criteria

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

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My blood pressure is not under control.

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I have a history of heart or thyroid issues.

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I have a history of heart or thyroid disease.

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I have received an organ transplant.

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I have had radiation treatment on my scalp.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Changes in non-vellus Target Area Hair Counts (TAHC)

Subjects Evaluation of Treatment Benefit

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: VDPHL01 QD and Placebo QDExperimental Treatment1 Intervention

Placebo will be taken orally once a day in the AM. VDPHL01 will be taken orally once a day in the PM.

Group II: VDHPL01 BIDExperimental Treatment1 Intervention

VDPHL01 will be taken orally twice a day, once in the AM and once in the PM.

Group III: Placebo BID with treatment extension to VDPHL01 BIDPlacebo Group1 Intervention

Placebo will be taken orally twice a day, once in the AM and once in the PM for the first 6 months of the study. After month 6, VDPHL01 will be taken orally twice a day, once in the AM and once in the PM.

Group IV: Placebo BID with treatment extension to VDPHL01 QD and Placebo QDPlacebo Group1 Intervention

Placebo will be taken orally twice a day, once in the AM and once in the PM for the first 6 months of the study. After month 6, placebo will be taken orally once a day in the AM. VDPHL01 will be taken orally once a day in the PM.

0 / 6Eligibility criteria met