Androgenetic AlopeciaPhase 3NCT06972264
Safety and Efficacy of VDPHL01 in Males With AGA
A Phase 3 study testing VDPHL01 in people with Androgenetic Alopecia and AGA, run by Veradermics, Inc. at 44 sites in United States.
Trial summary
This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA). 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Androgenetic Alopecia, AGA, Male Pattern Baldness
- What is being tested?
- VDPHL01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 44 sitesUnited States
- Study dates
- 11 Mar 2025to Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is male 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 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.
Who cannot join
- 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 screening;
- Subject has had previous radiation of the scalp;
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- 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
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Site 60
Anderson, South Carolina, 29625
Site 76
Austin, Texas, 78746
Site 51
Austin, Texas, 78759
Site 73
Birmingham, Alabama, 35209
Site 89
Birmingham, Alabama, 35244
Site 71
Boca Raton, Florida, 33486
Site 80
Chestnut Hill, Massachusetts, 02467
Site 61
Chicago, Illinois, 60611
Site 72
Cincinnati, Ohio, 45236
Site 53
Clarksville, Indiana, 47129
Site 68
Clinton Township, Michigan, 48038
Site 74
College Station, Texas, 77845
Site 86
Coral Gables, Florida, 33134
Site 62
Coral Gables, Florida, 33146
Site 67
Dallas, Texas, 75230
Site 81
East Greenwich, Rhode Island, 02818
Site 69
Encino, California, 91436
Site 84
Glenn Dale, Maryland, 20769
Site 95
Hermitage, Tennessee, 37076
Site 82
Hickory, North Carolina, 28602
Site 92
Huntersville, North Carolina, 28078
Site 79
Leawood, Kansas, 66211
Site 52
Louisville, Kentucky, 40241
Site 64
Manhattan Beach, California, 90266
Site 99
Miami, Florida, 33173
Site 70
Mill Creek, Washington, 98012
Site 75
New Orleans, Louisiana, 70124
Site 63
Norfolk, Virginia, 23502
Site 85
Norfolk, Virginia, 23502
Site 93
Northridge, California, 91324
Site 54
Ocala, Florida, 34470
Site 77
Phoenix, Arizona, 85006
Site 55
Plainfield, Indiana, 46168
Site 78
Plano, Texas, 75024
Site 57
Portland, Oregon, 97210
Site 59
Quincy, Massachusetts, 02169
Site 87
Rockville, Maryland, 20850
Site 88
San Antonio, Texas, 78218
Site 90
Sandy Springs, Georgia, 30328
Site 66
Santa Monica, California, 90404
Site 91
Sugarland, Texas, 77479
Site 96
Tamarac, Florida, 33321
Site 94
Thousand Oaks, California, 91320
Site 83
Troy, Michigan, 48084
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-dose Study to Evaluate the Efficacy and Safety of VDPHL01 in Male Subjects With Androgenetic Alopecia
This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA).
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).
- Conditions
- Androgenetic Alopecia, AGA, Male Pattern Baldness
- Being tested
- VDPHL01, Placebo
- Keywords
- Hair Loss, Male Hair Loss
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VDPHL01Drug
VDPHL01 Extended Release (ER) Tablet
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| VDHPL01 BID | Experimental | VDPHL01 will be taken orally twice a day, once in the AM and once in the PM. Receives: Drug: VDPHL01 |
| VDPHL01 QD and Placebo QD | Experimental | 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. Receives: Drug: VDPHL01 |
| Placebo BID with treatment extension to VDPHL01 BID | Placebo comparator | 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. Receives: Drug: Placebo |
| Placebo BID with treatment extension to VDPHL01 QD and Placebo QD | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in non-vellus Target Area Hair Counts (TAHC)
Change from baseline in non-vellus TAHC using digital image analysis at Month 6.
Measured: Month 6
Subjects Evaluation of Treatment Benefit
Subjects will rate their treatment benefit by responding to a hair assessment scale. The proportion of subjects by each response category will be reported at Month 6.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start11 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Veradermics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reid Waldman, M.D., Study chair, Veradermics, Inc.Timothy Durso, M.D., Study chair, Veradermics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972264
- Sponsor's protocol ID
- 250-13951-304
- Status last verified
- Feb 2026
- First submitted
- 6 May 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-dose Study to Evaluate the Efficacy and Safety of VDPHL01 in Male Subjects With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT06972264
- Acronym / sponsor ID
- 250-13951-304
- Conditions
- Androgenetic Alopecia, AGA, Male Pattern Baldness
- Keywords
- Hair Loss, Male Hair Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Veradermics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA).
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VDHPL01 BID | Experimental | Drug: VDPHL01VDPHL01 will be taken orally twice a day, once in the AM and once in the PM. |
| VDPHL01 QD and Placebo QD | Experimental | Drug: VDPHL01Placebo 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 BID with treatment extension to VDPHL01 BID | Placebo comparator | Drug: PlaceboPlacebo 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 BID with treatment extension to VDPHL01 QD and Placebo QD | Placebo comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is male 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 read, understand, and complete required questionnaires in English;
Key exclusion criteria (15 listed)
- 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 screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VDPHL01VDPHL01 Extended Release (ER) Tablet | Drug | VDHPL01 BID, VDPHL01 QD and Placebo QD |
| PlaceboPlacebo | Drug | Placebo BID with treatment extension to VDPHL01 BID, Placebo BID with treatment extension to VDPHL01 QD and Placebo QD |
Primary outcome
Changes in non-vellus Target Area Hair Counts (TAHC)
Time frame: Month 6
Change from baseline in non-vellus TAHC using digital image analysis at Month 6.
Subjects Evaluation of Treatment Benefit
Time frame: Month 6
Subjects will rate their treatment benefit by responding to a hair assessment scale. The proportion of subjects by each response category will be reported at Month 6.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Androgenetic Alopecia
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Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
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Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
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Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reid Waldman, M.D. study chair
Veradermics, Inc.
Timothy Durso, M.D. study chair
Veradermics, Inc.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VDPHL01 in people with Androgenetic Alopecia and AGA, run by Veradermics, Inc. at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in non-vellus Target Area Hair Counts (TAHC) (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.