Androgenetic AlopeciaPhase 2/3NCT06724614
Efficacy and Safety of VDPHL01 in Males With AGA
A Phase 2/3 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
- 6 Nov 2024to Sep 2026
- Phase
- Phase 2/3
- 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 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.
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 43
Atlanta, Georgia, 30329
Site 17
Aventura, Florida, 33180
Site 41
Baton Rouge, Louisiana, 70809
Site 40
Bellaire, Texas, 77401
Site 36
Birmingham, Alabama, 35203
Site 39
Boardman, Ohio, 44512
Site 31
Boise, Idaho, 83704
Site 25
Brandon, Florida, 33511
Site 22
Brighton, Massachusetts, 02135
Site 08
Broomall, Pennsylvania, 19073
Site 05
Castle Rock, Colorado, 80109
Site 26
Clarkston, Michigan, 48346
Site 11
Columbus, Ohio, 43215
Site 13
Covington, Louisiana, 70433
Site 44
Dallas, Texas, 75231
Site 24
Englewood, Colorado, 80111
Site 30
Fort Smith, Arkansas, 72916
Site 07
Fountain Valley, California, 92728
Site 02
Fremont, California, 94538
Site 20
Greensville, South Carolina, 29615
Site 18
Hackensack, New Jersey, 07601
Site 42
Hollywood, Florida, 33021
Site 14
Houston, Texas, 77056
Site 15
Indianapolis, Indiana, 46250
Site 37
Kew Gardens, New York, 11415
Site 09
Knoxville, Tennessee, 37909
Site 29
Lynchburg, Virginia, 24501
Site 12
Metairie, Louisiana, 70006
Site 16
Murfreesboro, Tennessee, 37130
Site 04
Nashville, Tennessee, 37215
Site 32
New Albany, Indiana, 47150
Site 06
New Brighton, Minnesota, 55112
Site 38
New York, New York, 10075
Site 28
Phoenix, Arizona, 85018
Site 10
Plymouth Meeting, Pennsylvania, 19462
Site 35
Rogers, Arkansas, 72758
Site 23
Rolling Meadows, Illinois, 60008
Site 33
Seattle, Washington, 98168
Site 34
Sherman Oaks, California, 91403
Site 01
Spokane, Washington, 99202
Site 03
Tampa, Florida, 33613
Site 21
Vista, California, 92083
Site 19
West Jordan, Utah, 84095
Site 27
West Lafayette, Indiana, 47906
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.
Read more
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.
- 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 posted9 Dec 2024
- Study start6 Nov 2024
- Primary completionFeb 2026 (estimated)
- Study completionSep 2026 (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 2/3
- 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
- NCT06724614
- Sponsor's protocol ID
- 250-13951-302
- Status last verified
- Nov 2025
- First submitted
- 4 Dec 2024
- Last updated
- 6 Nov 2025
- 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 6 Nov 2025. 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
- NCT06724614
- Acronym / sponsor ID
- 250-13951-302
- Conditions
- Androgenetic Alopecia, AGA, Male Pattern Baldness
- Keywords
- Hair Loss, Male Hair Loss
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Veradermics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 9 Dec 2024 (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).
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.
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 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;
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 6 Nov 2025.
- 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 2/3 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 6 Nov 2025. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 6 Nov 2025.