Androgenetic AlopeciaPhase 2NCT06527365
Safety and Efficacy of VDPHL01 in Males and Females With AGA
A Phase 2 study testing VDPHL01 in people with Androgenetic Alopecia and AGA, run by Veradermics, Inc. at 4 sites in United States.
Trial summary
This study will evaluate the safety and efficacy of VDPHL01 in male and female subjects with Androgenetic Alopecia (AGA). AGA (or pattern of hair loss) 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
- 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?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Jul 2024to Aug 2026
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is male or non-pregnant female 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 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;
- Subject has symptoms or history of certain heart or thyroid conditions;
- Subject has a history of cardiac and/or thyroid diseases;
- Subject has received an organ transplant;
- Subject has a history of prescription drug abuse or illicit drug use within 6 months of screening; history of alcohol abuse within 6 months prior to screening;
- Subject has a current or recent history of dietary or weight changes;
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- Subject has been diagnosed with COVID-19 within 16 weeks of baseline;
- Subject has used any topical scalp treatments for hair growth within 4 weeks prior to screening;
- Subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, etc. within 6 months prior to screening;
- Subject has had previous radiation of the scalp;
- Subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12 weeks prior to screening;
- Subject has used systemic beta blockers within 12 weeks prior to screening;
- Subject is currently enrolled in an investigational drug, biologic, or device study or has used an investigational treatment within 30 days 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
03
Hackensack, New Jersey, 07601
04
New Albany, Indiana, 47150
01
San Diego, California, 92123
02
South Jordan, Utah, 84095
About this study
Official title: An Open-Label Multi-Dose Study to Evaluate the Safety and Efficacy of VDPHL01 in Male and Female Subjects With Androgenetic Alopecia
This study will evaluate the safety and efficacy of VDPHL01 in male and female subjects with Androgenetic Alopecia (AGA).
AGA (or pattern of hair loss) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablets for males and VDPHL01 4.5 mg Tablets for females are an investigational oral drug to treat male and female pattern baldness.
This multiple center, open-label, 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). Male subjects that meet the study eligibility criteria will be administered VDPHL01 once daily for 12 months. Female subjects that meet the study eligibility criteria will be administered VDPHL01 either once or twice daily for 12 months.
- Conditions
- Androgenetic Alopecia, AGA, Male Pattern Baldness
- Being tested
- VDPHL01
- Keywords
- Hair Loss, Male Hair Loss, Female 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
| Study group | Role | What they receive |
|---|---|---|
| VDPHL01 Tablet | Experimental | Not described Receives: Drug: VDPHL01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in non-vellus Total Area Hair Count (TAHC)
Change from baseline in non-vellus TAHC using digital image analysis at Month 12.
Measured: Month 12
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 12.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start8 Jul 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Males will not be randomized. Females will be assigned once a day or twice a day treatment in an alternating fashion at each site.
- Masking
- None (open label)
- Enrolment
- 70 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 director, Veradermics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527365
- Sponsor's protocol ID
- 250-13951-207
- Status last verified
- Nov 2025
- First submitted
- 25 Jul 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
- An Open-Label Multi-Dose Study to Evaluate the Safety and Efficacy of VDPHL01 in Male and Female Subjects With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT06527365
- Acronym / sponsor ID
- 250-13951-207
- Conditions
- Androgenetic Alopecia, AGA, Male Pattern Baldness
- Keywords
- Hair Loss, Male Hair Loss, Female Hair Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Veradermics, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 30 Jul 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 and female subjects with Androgenetic Alopecia (AGA).
AGA (or pattern of hair loss) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablets for males and VDPHL01 4.5 mg Tablets for females are an investigational oral drug to treat male and female pattern baldness.
This multiple center, open-label, 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). Male subjects that meet the study eligibility criteria will be administered VDPHL01 once daily for 12 months. Female subjects that meet the study eligibility criteria will be administered VDPHL01 either once or twice daily for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Males will not be randomized. Females will be assigned once a day or twice a day treatment in an alternating fashion at each site.
| Arm | Type | Receives |
|---|---|---|
| VDPHL01 Tablet | Experimental | Drug: VDPHL01 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is male or non-pregnant female 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 (14 listed)
- Subject has uncontrolled blood pressure;
- Subject has symptoms or history of certain heart or thyroid conditions;
- Subject has a history of cardiac and/or thyroid diseases;
- Subject has received an organ transplant;
- Subject has a history of prescription drug abuse or illicit drug use within 6 months of screening; history of alcohol abuse within 6 months prior to 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 | VDPHL01 Tablet |
Primary outcome
Changes in non-vellus Total Area Hair Count (TAHC)
Time frame: Month 12
Change from baseline in non-vellus TAHC using digital image analysis at Month 12.
Subjects Evaluation of Treatment Benefit
Time frame: Month 12
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 12.
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.
- Individual participant dataSharing planned: Undecided
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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 director
Veradermics, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VDPHL01 in people with Androgenetic Alopecia and AGA, run by Veradermics, Inc. at 4 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 7 inclusion and 14 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 4 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Total Area Hair Count (TAHC) (time frame: Month 12). 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.