VDPHL01 for Male Pattern Baldness

Recruiting at 42 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new pill, VDPHL01, to determine its safety and effectiveness in treating male pattern baldness, a common genetic condition causing hair loss. Participants will take either the pill or a placebo (a pill without active ingredients) and visit the study center 11 times over 13 months. The trial suits men with mild to moderate male pattern baldness who are in good health, willing to keep their hair at least 1/4 inch long, and agree to a small tattoo on their scalp for study purposes. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop certain medications before joining the trial. There are specific 'washout' periods (time without taking certain medications) for treatments like hormone therapy, oral hair growth treatments, and some other medications. It's best to discuss your current medications with the trial team to see if they are affected.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study did not provide specific safety data for VDPHL01. However, similar treatments, such as dutasteride used for hair loss, have demonstrated long-term safety with mostly mild side effects, like dizziness or fatigue. The late-stage testing of VDPHL01 suggests that earlier studies found the treatment to be fairly well-tolerated, with no major safety issues reported so far. Prospective participants should ask questions and stay informed when considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about VDPHL01 for male pattern baldness because it offers a novel approach compared to current treatments like minoxidil and finasteride. Unlike existing options that focus on stimulating hair growth or altering hormone levels, VDPHL01 introduces a new active ingredient that targets specific pathways involved in hair follicle health. Additionally, VDPHL01 offers flexible dosing regimens, either once or twice daily, which might improve patient compliance and convenience. This innovative approach has the potential to provide an effective alternative for those who haven't found success with traditional therapies.

What evidence suggests that VDPHL01 might be an effective treatment for male pattern baldness?

In a previous study, 55% of men using VDPHL01 noticed better hair coverage within two months. This suggests that VDPHL01 might effectively treat male pattern baldness. Early results also showed visible and measurable hair regrowth soon after starting the treatment. These findings offer hope that VDPHL01 can help men with Androgenetic Alopecia (AGA), a condition where hormones cause hair loss. This trial tests VDPHL01 with different schedules, either once or twice a day, to determine the optimal usage. ^{1 4 6 7 8}

Who Is on the Research Team?

Reid Waldman, M.D.

Principal Investigator

Veradermics, Inc.

Timothy Durso, M.D.

Principal Investigator

Veradermics, Inc.

Are You a Good Fit for This Trial?

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 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 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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: VDPHL01 QD and Placebo QD Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Veradermics, Inc.

Lead Sponsor

Trials

3

Recruited

700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06724614

NCT06724614 | Efficacy and Safety of VDPHL01 in Males ... 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 ...

2. veradermics.com veradermics.com/veradermics-announces-150million-seriesc-financing

Newsroom In addition, 55% of these males reported seeing much 'improved' or 'much improved' hair coverage in the same two-month period, increasing to ...

3. withpower.com withpower.com/trial/phase-2-and-3-alopecia-10-2024-2f36c

VDPHL01 for Male Pattern Baldness · Info for Participants 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06972264

Safety and Efficacy of VDPHL01 in Males With AGA 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 ...

5. thedermdigest.com thedermdigest.com/one-to-watch-veradermics-raises-150m-in-series-c-financing-shares-positive-preliminary-phase-2-data-for-oral-minoxidil-in-pattern-hair-loss/

One to Watch: Veradermics Raises $150M in Series C ... In related news, preliminary data from the male cohort from its ongoing Phase 2 trial of VDPHL01 showed visible and measurable regrowth as early as two months.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06972264

Safety and Efficacy of VDPHL01 in Males With AGA 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 ...

7. ctv.veeva.com ctv.veeva.com/study/efficacy-and-safety-of-vdphl01-in-males-with-aga

Efficacy and Safety of VDPHL01 in Males With AGA 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.

8. alviarmani.com alviarmani.com/vdphl01-veradermics-hair-loss-clinical-trial/

Veradermics VDPHL01: The Non-Hormonal Hair Loss ... Veradermics' VDPHL01 is in Phase 2/3 trials for male hair loss. Discover how this non-hormonal oral treatment may change hair restoration forever.