Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of VDPHL01 in Females With Androgenetic Alopecia
Led by Veradermics, Inc. · Updated on 2025-11-24
552
Participants Needed
71
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of VDPHL01, an investigational oral drug, in female subjects with Androgenetic Alopecia AGA, a genetic condition causing hair loss due to an excessive response to hormones called androgens. This Phase 3, multi-center, double-blind study aims to better understand treatment outcomes for women aged 18 to 65 with mild to moderate AGA. The study is sponsored by Veradermics, Inc. and includes about 13 months of participation with 11 scheduled visits. Participants will be randomly assigned to one of several groups receiving different regimens of VDPHL01 or placebo. Some groups take VDPHL01 twice daily BID for the entire 12 months, while others begin with placebo or a combination of VDPHL01 once daily QD and placebo before switching treatments after 6 months. The study maintains a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo during the first 6 months. Throughout the study, participants will attend visits for screening, baseline assessment, and follow-ups at weeks 2, months 1, 2, 4, 6, 8, 10, 12, and 13. Researchers will evaluate hair counts in target areas at 6 months and participants own assessment of treatment benefit. Participants agree to maintain consistent hair length, style, and color, and will have a small tattoo placed on their scalp for photographic monitoring. Safety and treatment effects will be carefully monitored during the study period.
CONDITIONS
Brief Title
Safety and Efficacy of VDPHL01 in Females With Androgenetic Alopecia (AGA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 65 years
- Clinical diagnosis of mild to moderate Androgenetic Alopecia
- Good general health with adequate kidney and liver function
- Willing to maintain at least 1/4 inch hair length and consistent hairstyle, length, and color throughout the study
- Willing to keep consistent hair care products and routines during the study
- Able and willing to take the study drug as directed and complete questionnaires in English
- Able and willing to swallow the study drug whole
- Agree to have a small tattoo placed on the scalp
- Agree to have the tattooed area photographed at study visits
You will not qualify if you...
- Uncontrolled high blood pressure or orthostatic hypotension
- History or symptoms of certain heart or thyroid problems
- Hair loss caused by conditions other than Androgenetic Alopecia
- Recent or current dietary or weight changes, including use of GLP-1 agonists
- Diagnosis of COVID-19 within 16 weeks before baseline
- Previous radiation treatment to the scalp
- Recent use of hormone replacement therapy or hormonal modulators within 6 months
- Recent use of oral hair growth treatments or systemic retinoids within 6 months
- Recent use of systemic calcium channel blockers or beta blockers within 12 weeks
- Recent use of systemic cimetidine, ketoconazole, diazoxide, or corticosteroids within 12 weeks
- Recent scalp procedures including surgery, laser, light, micro-needling, injections, or platelet-rich plasma within 6 months
- Recent use of topical scalp treatments for hair growth within 12 weeks
- Use of any other medication or therapy that might interfere with the study
- Any other condition that may interfere with participation, as judged by the investigator
Research Team
A
AGA Study Manager
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