Safety and Efficacy of VDMN-21 Patch in Subjects With Common Warts
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
1 other identifier
interventional
153
1 country
16
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2023
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2023
CompletedFirst Submitted
Initial submission to the registry
March 22, 2023
CompletedFirst Posted
Study publicly available on registry
April 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2025
CompletedMay 8, 2025
May 1, 2025
2 years
March 22, 2023
May 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline up to Day 134
Other Outcomes (2)
Proportion of subjects with complete clinical resolution of Target Lesion by visit
Days 22, 43, 64, 85, 106, and 134
Proportion of subjects with complete clinical resolution of all the Non-Target Lesion(s) by visit
Days 22, 43, 64, 85, 106, and 134
Study Arms (3)
Treatment Group A (Low Dose)
EXPERIMENTALLow 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)
EXPERIMENTALHigh 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 COMPARATORVehicle 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).
Interventions
Microneedle patch containing 125 mcg of active drug
Microneedle patch containing 250 mcg of active drug
Placebo microneedle patch containing no active drug (i.e., placebo)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Site 07
Fort Smith, Arkansas, 72916, United States
Site 16
San Diego, California, 92123, United States
Site 02
Plainfield, Indiana, 46168, United States
Site 13
Louisville, Kentucky, 40241, United States
Site 15
Baton Rouge, Louisiana, 70809, United States
Site 09
New Brighton, Minnesota, 55112, United States
Site 01
Anderson, South Carolina, 29621, United States
Site 06
Greenville, South Carolina, 29615, United States
Site 11
Knoxville, Tennessee, 37909, United States
Site 03
Arlington, Texas, 76011, United States
Site 04
Austin, Texas, 78759, United States
Site 10
College Station, Texas, 77845, United States
Site 12
Houston, Texas, 77056, United States
Site 05
Pflugerville, Texas, 78660, United States
Site 14
Norfolk, Virginia, 23502, United States
Site 08
Spokane, Washington, 99202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2023
First Posted
April 5, 2023
Study Start
February 28, 2023
Primary Completion
February 25, 2025
Study Completion
February 25, 2025
Last Updated
May 8, 2025
Record last verified: 2025-05