Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
480 participants
INTERVENTIONAL
2025-03-11
2027-07-31
Brief Summary
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AGA (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablet is an investigational oral drug to treat male pattern baldness.
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).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VDHPL01 BID
VDPHL01 will be taken orally twice a day, once in the AM and once in the PM.
VDPHL01
VDPHL01 Extended Release (ER) Tablet
VDPHL01 QD and Placebo QD
Placebo will be taken orally once a day in the AM or PM. VDPHL01 will be taken orally once a day in the AM or PM.
VDPHL01
VDPHL01 Extended Release (ER) Tablet
Placebo BID with treatment extension to VDPHL01 BID
Placebo will be taken orally twice a day, once in the AM and once in the PM for the first 6 months of the study. After month 6, VDPHL01 will be taken orally twice a day, once in the AM and once in the PM.
Placebo
Placebo
Placebo BID with treatment extension to VDPHL01 QD and Placebo QD
Placebo will be taken orally twice a day, once in the AM and once in the PM for the first 6 months of the study. After month 6, placebo will be taken orally once a day in the AM or PM. VDPHL01 will be taken orally once a day in the AM or PM.
Placebo
Placebo
Interventions
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VDPHL01
VDPHL01 Extended Release (ER) Tablet
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 read, understand, and complete 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 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 screening;
* 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
18 Years
65 Years
MALE
No
Sponsors
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Veradermics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Reid Waldman, M.D.
Role: STUDY_CHAIR
Veradermics, Inc.
Timothy Durso, M.D.
Role: STUDY_CHAIR
Veradermics, Inc.
Locations
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Site 73
Birmingham, Alabama, United States
Site 89
Birmingham, Alabama, United States
Site 77
Phoenix, Arizona, United States
Site 69
Encino, California, United States
Site 64
Manhattan Beach, California, United States
Site 93
Northridge, California, United States
Site 66
Santa Monica, California, United States
Site 94
Thousand Oaks, California, United States
Site 71
Boca Raton, Florida, United States
Site 86
Coral Gables, Florida, United States
Site 62
Coral Gables, Florida, United States
Site 99
Miami, Florida, United States
Site 54
Ocala, Florida, United States
Site 96
Tamarac, Florida, United States
Site 90
Sandy Springs, Georgia, United States
Site 61
Chicago, Illinois, United States
Site 53
Clarksville, Indiana, United States
Site 55
Plainfield, Indiana, United States
Site 79
Leawood, Kansas, United States
Site 52
Louisville, Kentucky, United States
Site 75
New Orleans, Louisiana, United States
Site 84
Glenn Dale, Maryland, United States
Site 87
Rockville, Maryland, United States
Site 80
Chestnut Hill, Massachusetts, United States
Site 59
Quincy, Massachusetts, United States
Site 68
Clinton Township, Michigan, United States
Site 83
Troy, Michigan, United States
Site 82
Hickory, North Carolina, United States
Site 92
Huntersville, North Carolina, United States
Site 72
Cincinnati, Ohio, United States
Site 57
Portland, Oregon, United States
Site 81
East Greenwich, Rhode Island, United States
Site 60
Anderson, South Carolina, United States
Site 95
Hermitage, Tennessee, United States
Site 76
Austin, Texas, United States
Site 51
Austin, Texas, United States
Site 74
College Station, Texas, United States
Site 67
Dallas, Texas, United States
Site 78
Plano, Texas, United States
Site 88
San Antonio, Texas, United States
Site 91
Sugarland, Texas, United States
Site 63
Norfolk, Virginia, United States
Site 85
Norfolk, Virginia, United States
Site 70
Mill Creek, Washington, United States
Countries
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Central Contacts
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Related Links
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Related Info
Other Identifiers
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250-13951-304
Identifier Type: -
Identifier Source: org_study_id