VDPHL01 for Female Pattern Hair Loss

Recruiting at 69 trial locations

Overseen By AGA Study Manager

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Veradermics, Inc.

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

Disqualifiers: Uncontrolled blood pressure, 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

552 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of a new oral drug, VDPHL01, for treating female pattern hair loss, scientifically known as Androgenetic Alopecia (AGA). AGA is a genetic condition where certain hormones cause excessive hair loss. Participants will receive either the new drug or a placebo (a harmless pill with no active drug) in different regimens over 13 months to compare results. Women diagnosed with mild to moderate AGA and who maintain stable hair care habits might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, if you are using hormone replacement therapy, oral treatments for hair growth, or certain other medications, you must stop them for a specific period before the trial starts. 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?

Research shows that VDPHL01, a new oral drug being tested for hair loss (Androgenetic Alopecia), is currently under study for safety. Although specific safety data is not yet available, the drug is now being tested in larger groups, indicating that earlier tests generally found it safe.

In past trials, participants rarely reported serious side effects. It's important to remember that the drug remains under study, and this research will further clarify its safety. For those considering joining the study, the drug's safe tolerance in earlier tests is a positive indication. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hair loss?

Most treatments for female pattern hair loss, like minoxidil or finasteride, work by stimulating hair follicles or blocking hormones that lead to hair thinning. But VDPHL01 works differently, offering a novel approach by potentially targeting different pathways to promote hair growth. Researchers are excited because it is taken orally, providing a convenient alternative to topical applications. This could mean a new, effective option for women who have seen limited success with existing treatments.

What evidence suggests that VDPHL01 might be an effective treatment for female pattern hair loss?

Studies have shown promising results for VDPHL01 in treating female pattern hair loss, also known as androgenetic alopecia (AGA). Research indicates that VDPHL01 reduces the hair follicles' strong reaction to hormones, a main cause of AGA. Previous patients experienced improvements in hair thickness and quality, suggesting the treatment's effectiveness. Early findings suggest that VDPHL01 could become a preferred option for managing hair loss in women. This investigational drug is still under study in this trial, where participants may receive VDPHL01 in different dosing regimens or a placebo, but the initial data is encouraging. ^{1 3 4 6 7}

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 women with Androgenetic Alopecia, a type of genetic hair loss. Participants should be experiencing this specific form of hair thinning and willing to attend multiple study visits over about 13 months.

Inclusion Criteria

Agrees to have the area photographed at study visits as indicated in the protocol

I am a woman aged between 18 and 65.

I have been diagnosed with mild to moderate age-related hair loss.

Exclusion Criteria

I have a history of heart or thyroid conditions.

I was diagnosed with COVID-19 within the last 16 weeks.

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

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 continue or switch to VDPHL01 for an additional 6 months, with visits at month 6, month 8, month 10, and month 12

6 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• VDPHL01

Trial Overview The trial tests VDPHL01, an oral medication taken once (QD) or twice daily (BID), against a placebo to see if it's safe and effective in treating female pattern hair loss. The study is double-blind, meaning neither the researchers nor participants know who gets the real drug or placebo.

How Is the Trial Designed?

Group I: VDPHL01 QD and Placebo QD Experimental Treatment 2 Interventions

Placebo will be taken orally once a day (QD) in the AM or PM. VDPHL01 will be taken orally once a day (QD) in the AM or PM for the first 6 months of the study. After month 6, subject will continue this same dose regimen for an additional 6 months.

Group II: VDPHL01 BID Experimental Treatment 1 Intervention

VDPHL01 will be taken orally twice a day (BID), once in the AM and once in the PM for the first 6 months of the study. After month 6, subject will continue VDPHL01 BID for an additional 6 months.

Group III: Placebo BID with treatment extension to VDPHL01 BID Placebo Group 1 Intervention

Placebo will be taken orally twice a day (BID), once in the AM and once in the PM for the first 6 months of the study. After month 6, subject will switch to VDPHL01 BID group, and take VDPHL01 orally twice a day (BID), once in the AM and once in the PM for an additional 6 months.

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 (BID), once in the AM and once in the PM for the first 6 months of the study. After month 6, subject will switch to VDPHL01 QD and Placebo QD group, and take placebo orally once a day in the AM or PM; VDPHL01 will be taken orally once a day in the AM or PM for an additional 6 months.

Who Is Running the Clinical Trial?

Veradermics, Inc.

Lead Sponsor

Trials

3

Recruited

700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07146022

NCT07146022 | Safety and Efficacy of VDPHL01 in ... This study will evaluate the safety and efficacy of VDPHL01 in female subjects with Androgenetic Alopecia (AGA).

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

Newsroom VDPHL01 is being developed to become the preferred treatment for women and men with pattern hair loss, also known as androgenetic alopecia.

3. withpower.com withpower.com/trial/phase-3-androgenetic-alopecia-aga-6-2025-1496c

VDPHL01 for Female Pattern Hair Loss This study will evaluate the safety and efficacy of VDPHL01 in female subjects with Androgenetic Alopecia (AGA). AGA is a genetic disorder caused by an ...

4. trial.medpath.com trial.medpath.com/clinical-trial/9aeb818903ed7e53/nct07146022-randomized-study-vdphl01-female-androgenetic-alopecia

Safety and Efficacy of VDPHL01 in Females With ... - MedPath This study will evaluate the safety and efficacy of VDPHL01 in female subjects with Androgenetic Alopecia (AGA). AGA is a genetic disorder caused by an ...

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 ... Veradermics is evaluating the safety and efficacy of VDPHL01 in an open-label, multi-dose Phase 2 trial of women and men with mild-to-moderate pattern hair loss ...

6. ctv.veeva.com ctv.veeva.com/study/safety-and-efficacy-of-vdphl01-in-females-with-androgenetic-alopecia-aga

Safety and Efficacy of VDPHL01 in Females With ... This study will evaluate the safety and efficacy of VDPHL01 in female subjects with Androgenetic Alopecia (AGA).

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06527365

NCT06527365 | Safety and Efficacy of VDPHL01 in Males ... This study will evaluate the safety and efficacy of VDPHL01 in male and female subjects with Androgenetic Alopecia (AGA).