VDPHL01 oral treatment for women with androgenetic alopecia.
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Dose Study to Evaluate the Efficacy and Safety of VDPHL01 in Female Subjects With Androgenetic Alopecia
This 13-month, double-blind study will test whether taking VDPHL01 once or twice daily helps women ages 18–65 with mild-to-moderate androgenetic alopecia and is safe compared with placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 552 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Veradermics, Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 71 sites (Birmingham, Alabama and 70 other locations) |
| Trial ID | NCT07146022 on ClinicalTrials.gov |
What this trial studies
This multicenter, double-blind Phase 3 trial randomizes women with mild-to-moderate androgenetic alopecia to oral VDPHL01 once daily, VDPHL01 twice daily, or matching placebo. The study lasts about 13 months and includes 11 clinic visits, standardized scalp photography, and a microdot tattoo to mark assessment sites. Safety monitoring includes regular checks of renal and hepatic function and screening for blood pressure, heart, and thyroid conditions. Participants must maintain consistent hair length, style, and hair care regimens and be able to swallow the study medication whole.
Who should consider this trial
Good fit: Women aged 18–65 with a clinical diagnosis of mild-to-moderate androgenetic alopecia who are in good general health, can swallow pills, will maintain consistent hair length and care, and agree to scalp marking and photography are the intended participants.
Not a fit: Women with severe AGA, uncontrolled blood pressure, certain heart or thyroid conditions, or inadequate liver or kidney function may not benefit or be eligible for this intervention.
Why it matters
Potential benefit: If successful, VDPHL01 could provide an effective oral option to slow or reverse hair thinning in women with AGA.
How similar studies have performed: Oral treatments such as oral minoxidil have shown benefit for female pattern hair loss, but VDPHL01 is a novel investigational oral agent with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject is a female aged 18-65 years old; * Subject has a clinical diagnosis of mild to moderate AGA; * Subject is in good general health and has adequate 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 and can read, understand, and complete the required questionnaires in English; * Subject is willing and able to swallow study drug whole; * 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 or orthostatic hypotension; * Subject has symptoms or history of certain heart or thyroid conditions; * Subject has a history of or active hair loss due to conditions/diseases other than AGA; * Subject has a current or recent history of dietary or weight changes, including use of GLP-1 agonists; * Subject has been diagnosed with COVID-19 within 16 weeks of baseline; * Subject has had previous radiation of the scalp; * Use of any of the following treatments within the indicated washout period before screening: * Subject has used hormone replacement therapy or hormonal modulators within 6 months prior to screening * Subject has used oral treatments for hair growth or that can affect hair growth, including systemic retinoids, within 6 months of screening * Subject has used systemic calcium channel blockers or beta blockers within 12 weeks prior to screening * Subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12 weeks prior to screening * Subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, injections, platelet rich plasma within 6 months prior to screening * Subject has used any topical scalp treatments for hair growth within 12 weeks 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; * Subject has any other condition that, in the investigator's opinion, interfere with the study
Where this trial is running
Birmingham, Alabama and 70 other locations
- Site 73 — Birmingham, Alabama, United States (Recruiting)
- Site 89 — Birmingham, Alabama, United States (Recruiting)
- Site 77 — Phoenix, Arizona, United States (Recruiting)
- Site 30 — Fort Smith, Arkansas, United States (Recruiting)
- Site 69 — Encino, California, United States (Recruiting)
- Site 2 — Fremont, California, United States (Recruiting)
- Site 64 — Manhattan Beach, California, United States (Recruiting)
- Site 93 — Northridge, California, United States (Recruiting)
- Site 66 — Santa Monica, California, United States (Recruiting)
- Site 34 — Sherman Oaks, California, United States (Recruiting)
- Site 94 — Thousand Oaks, California, United States (Recruiting)
- Site 21 — Vista, California, United States (Recruiting)
- Site 5 — Castle Rock, Colorado, United States (Recruiting)
- Site 24 — Greenwood Village, Colorado, United States (Recruiting)
- Site 17 — Aventura, Florida, United States (Recruiting)
- Site 71 — Boca Raton, Florida, United States (Recruiting)
- Site 86 — Coral Gables, Florida, United States (Recruiting)
- Site 62 — Coral Gables, Florida, United States (Recruiting)
- Site 99 — Miami, Florida, United States (Recruiting)
- Site 54 — Ocala, Florida, United States (Recruiting)
- Site 43 — Atlanta, Georgia, United States (Recruiting)
- Site 90 — Sandy Springs, Georgia, United States (Recruiting)
- Site 31 — Boise, Idaho, United States (Recruiting)
- Site 61 — Chicago, Illinois, United States (Not_yet_recruiting)
- Site 53 — Clarksville, Indiana, United States (Recruiting)
- Site 15 — Indianapolis, Indiana, United States (Recruiting)
- Site 32 — New Albany, Indiana, United States (Recruiting)
- Site 55 — Plainfield, Indiana, United States (Recruiting)
- Site 27 — West Lafayette, Indiana, United States (Recruiting)
- Site 79 — Leawood, Kansas, United States (Recruiting)
- Site 52 — Louisville, Kentucky, United States (Recruiting)
- Site 41 — Baton Rouge, Louisiana, United States (Recruiting)
- Site 13 — Covington, Louisiana, United States (Recruiting)
- Site 12 — Metairie, Louisiana, United States (Recruiting)
- Site 75 — New Orleans, Louisiana, United States (Recruiting)
- Site 84 — Glenn Dale, Maryland, United States (Recruiting)
- Site 87 — Rockville, Maryland, United States (Recruiting)
- Site 22 — Brighton, Massachusetts, United States (Recruiting)
- Site 80 — Chestnut Hill, Massachusetts, United States (Recruiting)
- Site 59 — Quincy, Massachusetts, United States (Recruiting)
- Site 26 — Clarkston, Michigan, United States (Recruiting)
- Site 68 — Clinton Township, Michigan, United States (Recruiting)
- Site 83 — Southfield, Michigan, United States (Not_yet_recruiting)
- Site 98 — Medina, Minnesota, United States (Not_yet_recruiting)
- Site 56 — Minneapolis, Minnesota, United States (Recruiting)
- Site 6 — New Brighton, Minnesota, United States (Recruiting)
- Site 18 — Hackensack, New Jersey, United States (Recruiting)
- Site 37 — Kew Gardens, New York, United States (Recruiting)
- Site 97 — New York, New York, United States (Not_yet_recruiting)
- Site 82 — Hickory, North Carolina, United States (Recruiting)
+21 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: AGA Study Manager
- Email: clinicalresearch@therapeuticsinc.com
- Phone: 858-571-1800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.