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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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
480 participants
INTERVENTIONAL
2024-11-06
2026-09-30
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).
The first 7 visits will be part of the placebo-controlled period. The next 3 visits will be part of the treatment extension phase. All subjects will receive active drug in the treatment extension phase.
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 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 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 36
Birmingham, Alabama, United States
Site 28
Phoenix, Arizona, United States
Site 30
Fort Smith, Arkansas, United States
Site 35
Rogers, Arkansas, United States
Site 07
Fountain Valley, California, United States
Site 02
Fremont, California, United States
Site 34
Sherman Oaks, California, United States
Site 21
Vista, California, United States
Site 05
Castle Rock, Colorado, United States
Site 24
Englewood, Colorado, United States
Site 17
Aventura, Florida, United States
Site 25
Brandon, Florida, United States
Site 42
Hollywood, Florida, United States
Site 03
Tampa, Florida, United States
Site 43
Atlanta, Georgia, United States
Site 31
Boise, Idaho, United States
Site 23
Rolling Meadows, Illinois, United States
Site 15
Indianapolis, Indiana, United States
Site 32
New Albany, Indiana, United States
Site 27
West Lafayette, Indiana, United States
Site 41
Baton Rouge, Louisiana, United States
Site 13
Covington, Louisiana, United States
Site 12
Metairie, Louisiana, United States
Site 22
Brighton, Massachusetts, United States
Site 26
Clarkston, Michigan, United States
Site 06
New Brighton, Minnesota, United States
Site 18
Hackensack, New Jersey, United States
Site 37
Kew Gardens, New York, United States
Site 38
New York, New York, United States
Site 39
Boardman, Ohio, United States
Site 11
Columbus, Ohio, United States
Site 08
Broomall, Pennsylvania, United States
Site 10
Plymouth Meeting, Pennsylvania, United States
Site 20
Greensville, South Carolina, United States
Site 09
Knoxville, Tennessee, United States
Site 16
Murfreesboro, Tennessee, United States
Site 04
Nashville, Tennessee, United States
Site 40
Bellaire, Texas, United States
Site 44
Dallas, Texas, United States
Site 14
Houston, Texas, United States
Site 19
West Jordan, Utah, United States
Site 29
Lynchburg, Virginia, United States
Site 33
Seattle, Washington, United States
Site 01
Spokane, Washington, United States
Countries
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Related Links
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Related Info
Other Identifiers
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250-13951-302
Identifier Type: -
Identifier Source: org_study_id