VDPHL01 for Male Pattern Baldness

Recruiting at 25 trial locations

Overseen By Kate Mateja, MBA

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Veradermics, Inc.

Must not be taking: Hormone modulators, Retinoids, Corticosteroids, others

Disqualifiers: Heart conditions, Thyroid conditions, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 11

Duration: 6 months

480 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA). AGA (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablet is an investigational oral drug to treat male pattern baldness. This multi-center, double blind, study will last about 13 months and includes 11 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13).

Research Team

Reid Waldman, M.D.

Principal Investigator

Veradermics, Inc.

Timothy Durso, M.D.

Principal Investigator

Veradermics, Inc.

Eligibility Criteria

This trial is for men with Androgenetic Alopecia, also known as male pattern baldness. It's a genetic condition where too much response to hormones causes hair loss. Participants should be able to attend 11 study visits over approximately 13 months.

Inclusion Criteria

Subject agrees to have a micro dot tattoo placed on their scalp

Subject agrees to have this area photographed at study visits as indicated in the protocol.

I am a man between 18 and 65 years old.

Exclusion Criteria

Subject has used any other therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study

Subject has any other condition that, in the investigator's opinion, interfere with the study

My blood pressure is not well-controlled, or I get dizzy when standing up.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive VDPHL01 or placebo for 6 months, with visits at baseline, week 2, month 1, month 2, and month 4

6 months

5 visits (in-person)

Treatment Extension

Participants on placebo switch to VDPHL01, continuing treatment for an additional 6 months with visits at month 6, month 8, month 10, month 12, and month 13

6 months

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• VDPHL01

Trial Overview The trial is testing VDPHL01, an investigational oral tablet designed to treat male pattern baldness. Men will either receive VDPHL01 or a placebo without knowing which one they're taking (double-blind). The study aims to see if the drug is safe and effective.

Participant Groups

Group I: VDPHL01 QD and Placebo QD Experimental Treatment 1 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 BID Experimental Treatment 1 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 BID Placebo Group 1 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 QD Placebo Group 1 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.

Who Is Running the Clinical Trial?

Veradermics, Inc.

Lead Sponsor

Trials

3

Recruited

700+