NCT07146022 Safety and Efficacy of VDPHL01 in Females With Androgenetic Alopecia (AGA)
| NCT ID | NCT07146022 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Veradermics, Inc. |
| Condition | Androgenetic Alopecia (AGA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 552 participants |
| Start Date | 2025-07-25 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 552 participants in total. It began in 2025-07-25 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 excessive (too much) hair follicle response to androgens (hormones) that causes hair loss. VDPHL01 is an investigational oral drug to treat AGA. This multi-center, double blind, study will last about 13 months and includes 11 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13).
Eligibility 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
Contact & Investigator
Reid Waldman, M.D.
STUDY CHAIR
Veradermics, Inc.
Frequently Asked Questions
Who can join the NCT07146022 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Androgenetic Alopecia (AGA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07146022 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 552 participants.
Is NCT07146022 currently recruiting?
Yes, NCT07146022 is actively recruiting participants. Contact the research team at clinicalresearch@therapeuticsinc.com for enrollment information.
Where is the NCT07146022 trial being conducted?
This trial is being conducted at Birmingham, United States, Birmingham, United States, Phoenix, United States, Fort Smith, United States and 11 additional locations.
Who is sponsoring the NCT07146022 clinical trial?
NCT07146022 is sponsored by Veradermics, Inc.. The principal investigator is Reid Waldman, M.D. at Veradermics, Inc.. The trial plans to enroll 552 participants.