Evaluating a new oral treatment for hair loss in men and women

An Open-Label Multi-Dose Study to Evaluate the Safety and Efficacy of VDPHL01 in Male and Female Subjects with Androgenetic Alopecia

This study is testing a new oral medication for hair loss in men and women to see if it helps them regrow hair.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Veradermics, Inc. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 4 sites (San Diego, California and 3 other locations)
• Trial ID: NCT06527365 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the safety and efficacy of VDPHL01, an investigational oral medication, in treating Androgenetic Alopecia (AGA) in both male and female participants. The study is designed as a multi-center, open-label trial lasting approximately 13 months, with participants attending 11 scheduled visits for monitoring and assessments. Male subjects will take VDPHL01 once daily, while female subjects may take it once or twice daily, depending on their eligibility. Participants must maintain specific hair conditions throughout the study to ensure consistent results.

Who should consider this trial

Good fit: Ideal candidates are healthy males and non-pregnant females aged 18-65 with mild to moderate AGA.

Not a fit: Patients with uncontrolled blood pressure or a history of certain heart or thyroid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for individuals suffering from hair loss due to AGA.

How similar studies have performed: While there have been studies on hair loss treatments, the specific approach of VDPHL01 is novel and has not been extensively tested in this manner.

Eligibility criteria

Inclusion Criteria:

* Subject is male or non-pregnant female aged 18-65 years old;
* Subject has a clinical diagnosis of mild to moderate AGA;
* Subject is in good general health and has normal renal and hepatic function;
* Subject is willing to maintain at least 1/4 inch length hair during the study with the same hairstyle, hair length, and hair color throughout the study; maintain consistent use of general hair care products and regimen through the entire study;
* Subject is willing and able to administer the test article as directed read, understand, and complete required questionnaires in English;
* 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.

Exclusion Criteria:

* Subject has uncontrolled blood pressure;
* Subject has symptoms or history of certain heart or thyroid conditions;
* Subject has a history of cardiac and/or thyroid diseases;
* Subject has received an organ transplant;
* Subject has a history of prescription drug abuse or illicit drug use within 6 months of screening; history of alcohol abuse within 6 months prior to screening;
* Subject has a current or recent history of dietary or weight changes;
* Subject has been diagnosed with COVID-19 within 16 weeks of baseline;
* Subject has used any topical scalp treatments for hair growth within 4 weeks prior to screening;
* Subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, etc. within 6 months prior to screening;
* Subject has had previous radiation of the scalp;
* Subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12 weeks prior to screening;
* Subject has used systemic beta blockers within 12 weeks prior to screening;
* Subject is currently enrolled in an investigational drug, biologic, or device study or has used an investigational treatment within 30 days prior to screening;
* Subject has used any other therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study.

Where this trial is running

San Diego, California and 3 other locations

• 01 — San Diego, California, United States (Recruiting)
• 04 — New Albany, Indiana, United States (Recruiting)
• 03 — Hackensack, New Jersey, United States (Recruiting)
• 02 — South Jordan, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Jenica Lee, MPH

Conditions Androgenetic Alopecia; AGA; Male Pattern Baldness; Hair Loss; Male Hair Loss; Female Hair Loss