Verruca VulgarisPhase 2NCT05799157
Safety and Efficacy of VDMN-21 Patch in Subjects With Common Warts
A Phase 2 study testing VDMN-21 Patch Low Dose and VDMN-21 Patch High Dose in people with Verruca Vulgaris and Warts, run by Veradermics, Inc. at 16 sites in United States.
Trial summary
This Phase 2 study has been designed to determine the safety and efficacy of repeated treatment sessions of VDMN-21 patch at two dose strengths as compared to a matched vehicle control patch in subjects with verruca vulgaris Read more about this study
- Who is it for?
- Ages 9 to 65 years
- Conditions the study is for
- Verruca Vulgaris, Warts, Common Wart
- What is being tested?
- VDMN-21 Patch Low Dose and VDMN-21 Patch High Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 16 sitesUnited States
- Study dates
- 28 Feb 2023to 25 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 9 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is a male or non-pregnant female, 9 to 65 years of age.
- Subject has provided written informed consent/assent.
- Females must be post-menopausal, surgically sterile, or use an effective method of birth control. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Baseline.
- Subject has at least 1 and up to 8 common warts (verruca vulgaris),
- Subject is willing to undergo test article therapy as directed, comply with study instructions (including availability to a smart phone or equivalent device for telehealth visit requirements), and commit to all follow-up visits for the duration of the study.
- Subject is in good general health and free of any disease state or physical condition that might impair evaluation of the identified warts and/or treatment area or exposes the subject to an unacceptable risk by study participation.
Who cannot join
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject used or will use oral zinc and/or cimetidine within 30 days prior to enrollment or during the course of the study.
- Subject has received 3 or more prior treatments to the Target Lesion without resolution.
- Subject received any of the following therapies within the specified wash-out period prior to Baseline in the treatment area of the Target Lesion
- LASER, light or other energy-based therapy (e.g., intense pulsed light [IPL], PDT; 12 weeks
- Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester [SADBE], etc.), retinoids, hydrogen peroxide; 12 weeks
Show all 16Show fewer
- Cryotherapy, biopsy, electrodessication, curettage, antimetabolite therapy (e.g., 5- fluorouracil), cantharidin, or any other treatment that in the opinion of the Investigator may affect the Target Lesion; 6 weeks
- Over-the-counter (OTC) wart therapies, paring ± occlusion; 1 week
- Subject has scars, tattoos, or other features that may interfere with the evaluation of the Target Lesion, in the opinion in the investigator.
- Subject has a significant autoimmune condition or is immunocompromised based on their medical condition (e.g., HIV, malignancy, etc.), medication use, or other factors. Routine use of inhaled, intranasal or ophthalmologic corticosteroids during the study is allowed.
- Subject has received systemic immunosuppressive therapy such as steroids, methotrexate, cyclosporine, tacrolimus, chemotherapy, etc. within in 4 weeks prior to Baseline.
- Subject has any active malignancy or are undergoing treatment for any malignancy other than nonmelanoma skin cancer;
- Subject has history of significant ophthalmologic inflammatory disease, including uveitis.
- Subject is currently enrolled in an investigational drug, biologic, or device study.
- Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to Visit 1/Baseline.
- Subject has a history of allergy or sensitivity to this antigen extract or similar products.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Site 01
Anderson, South Carolina, 29621
Site 03
Arlington, Texas, 76011
Site 04
Austin, Texas, 78759
Site 15
Baton Rouge, Louisiana, 70809
Site 10
College Station, Texas, 77845
Site 07
Fort Smith, Arkansas, 72916
Site 06
Greenville, South Carolina, 29615
Site 12
Houston, Texas, 77056
Site 11
Knoxville, Tennessee, 37909
Site 13
Louisville, Kentucky, 40241
Site 09
New Brighton, Minnesota, 55112
Site 14
Norfolk, Virginia, 23502
Site 05
Pflugerville, Texas, 78660
Site 02
Plainfield, Indiana, 46168
Site 16
San Diego, California, 92123
Site 08
Spokane, Washington, 99202
About this study
Official title: Protocol 250-1951-201: A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of VDMN-21 in Subjects With Verruca Vulgaris
This Phase 2 study has been designed to determine the safety and efficacy of repeated treatment sessions of VDMN-21 patch at two dose strengths as compared to a matched vehicle control patch in subjects with verruca vulgaris
Read the detailed description
Protocol 250-12951-201 is a planned Phase 2 study entitled "A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of VDMN-21 in Subjects with Verruca Vulgaris". Eligible subjects will be randomized into one of the three treatment groups (high dose, low dose, vehicle).
- Conditions
- Verruca Vulgaris, Warts, Common Wart
- Being tested
- VDMN-21 Patch Low Dose, VDMN-21 Patch High Dose, Vehicle Patch
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VDMN-21 Patch Low DoseDrug
Microneedle patch containing 125 mcg of active drug
VDMN-21 Patch High DoseDrug
Microneedle patch containing 250 mcg of active drug
Vehicle PatchDrug
Placebo microneedle patch containing no active drug (i.e., placebo)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A (Low Dose) | Experimental | Low does patch will be applied adjacent to the target wart and remain in place for 5 minutes then removed. There may be up to 6 treatments (approximately 1 per month). Receives: Drug: VDMN-21 Patch Low Dose |
| Treatment Group B (High Dose) | Experimental | High does patch will be applied adjacent to the target wart and remain in place for 5 minutes then removed. There may be up to 6 treatments (approximately 1 per month). Receives: Drug: VDMN-21 Patch High Dose |
| Treatment Group C (Vehicle) | Placebo comparator | Vehicle patch will be applied adjacent to the target wart and remain in place for 5 minutes then removed. There may be up to 6 treatments (approximately 1 per month). Receives: Drug: Vehicle Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with complete clinical resolution of the Target Lesion at end of treatment period
Complete clinical resolution is defined as the target lesion with area = 0.
Measured: Baseline up to Day 134
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start28 Feb 2023
- Primary completion25 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Verruca VulgarisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veradermics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799157
- Sponsor's protocol ID
- 250-12951-201
- Status last verified
- May 2025
- First submitted
- 22 Mar 2023
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol 250-1951-201: A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of VDMN-21 in Subjects With Verruca Vulgaris
- ClinicalTrials.gov ID
- NCT05799157
- Acronym / sponsor ID
- 250-12951-201
- Conditions
- Verruca Vulgaris, Warts, Common Wart
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Veradermics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 5 Apr 2023 (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 Phase 2 study has been designed to determine the safety and efficacy of repeated treatment sessions of VDMN-21 patch at two dose strengths as compared to a matched vehicle control patch in subjects with verruca vulgaris
Detailed description
Protocol 250-12951-201 is a planned Phase 2 study entitled "A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of VDMN-21 in Subjects with Verruca Vulgaris". Eligible subjects will be randomized into one of the three treatment groups (high dose, low dose, vehicle).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A (Low Dose) | Experimental | Drug: VDMN-21 Patch Low DoseLow does patch will be applied adjacent to the target wart and remain in place for 5 minutes then removed. There may be up to 6 treatments (approximately 1 per month). |
| Treatment Group B (High Dose) | Experimental | Drug: VDMN-21 Patch High DoseHigh does patch will be applied adjacent to the target wart and remain in place for 5 minutes then removed. There may be up to 6 treatments (approximately 1 per month). |
| Treatment Group C (Vehicle) | Placebo comparator | Drug: Vehicle PatchVehicle patch will be applied adjacent to the target wart and remain in place for 5 minutes then removed. There may be up to 6 treatments (approximately 1 per month). |
Who may qualify
- Ages
- 9 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is a male or non-pregnant female, 9 to 65 years of age.
- Subject has provided written informed consent/assent.
- Females must be post-menopausal, surgically sterile, or use an effective method of birth control. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Baseline.
- Subject has at least 1 and up to 8 common warts (verruca vulgaris),
- Subject is willing to undergo test article therapy as directed, comply with study instructions (including availability to a smart phone or equivalent device for telehealth visit requirements), and commit to all follow-up visits for the duration of the study.
Key exclusion criteria (16 listed)
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject used or will use oral zinc and/or cimetidine within 30 days prior to enrollment or during the course of the study.
- Subject has received 3 or more prior treatments to the Target Lesion without resolution.
- Subject received any of the following therapies within the specified wash-out period prior to Baseline in the treatment area of the Target Lesion
- Subject has scars, tattoos, or other features that may interfere with the evaluation of the Target Lesion, in the opinion in the investigator.
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 |
|---|---|---|
| VDMN-21 Patch Low DoseMicroneedle patch containing 125 mcg of active drug | Drug | Treatment Group A (Low Dose) |
| VDMN-21 Patch High DoseMicroneedle patch containing 250 mcg of active drug | Drug | Treatment Group B (High Dose) |
| Vehicle PatchPlacebo microneedle patch containing no active drug (i.e., placebo) | Drug | Treatment Group C (Vehicle) |
Primary outcome
Proportion of subjects with complete clinical resolution of the Target Lesion at end of treatment period
Time frame: Baseline up to Day 134
Complete clinical resolution is defined as the target lesion with area = 0.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Verruca Vulgaris
Active, not recruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
Common Warts, Common Warts (Verruca Vulgaris)
RecruitingPhase 3
Long-Term Follow-up Study of Cantharidin (YCANTH [VP-102/TO-208]) in Patients With Common Warts (Verruca Vulgaris)
Common Warts (Verruca Vulgaris), Common Warts
Not yet recruitingPhase 2
Safety and Systemic Exposure of YCANTH (VP-102) in Subjects With Common Warts (Verruca Vulgaris) (COVE-5)
Common Warts, Common Warts (Verruca Vulgaris)
Active, not recruitingPhase 2
Intralesional Gardasil-9 for the Treatment of Recalcitrant Warts
Warts, Verruca (Warts)
RecruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-3)
Common Warts, Common Warts (Verruca Vulgaris)
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.
The record lists no contact. Use the official record to reach the sponsor.
16 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 VDMN-21 Patch Low Dose and VDMN-21 Patch High Dose in people with Verruca Vulgaris and Warts, run by Veradermics, Inc. at 16 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 6 inclusion and 16 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: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects with complete clinical resolution of the Target Lesion at end of treatment period (time frame: Baseline up to Day 134). 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 8 May 2025.