Safety and Efficacy of VDMN-21 Patch in Subjects With Common Warts

NCT ID: NCT05799157

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2025-02-25

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment Group A (Low Dose)

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).

Group Type: EXPERIMENTAL

VDMN-21 Patch Low Dose

Intervention Type: DRUG

Microneedle patch containing 125 mcg of active drug

Treatment Group B (High Dose)

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).

Group Type: EXPERIMENTAL

VDMN-21 Patch High Dose

Intervention Type: DRUG

Microneedle patch containing 250 mcg of active drug

Treatment Group C (Vehicle)

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).

Group Type: PLACEBO_COMPARATOR

Vehicle Patch

Intervention Type: DRUG

Placebo microneedle patch containing no active drug (i.e., placebo)

Interventions

VDMN-21 Patch Low Dose

Microneedle patch containing 125 mcg of active drug

Intervention Type: DRUG

VDMN-21 Patch High Dose

Microneedle patch containing 250 mcg of active drug

Intervention Type: DRUG

Vehicle Patch

Placebo microneedle patch containing no active drug (i.e., placebo)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

1. LASER, light or other energy-based therapy (e.g., intense pulsed light [IPL], PDT; 12 weeks

2. Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester [SADBE], etc.), retinoids, hydrogen peroxide; 12 weeks

3. 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

4. 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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Veradermics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Site 07

Fort Smith, Arkansas, United States

Site 16

San Diego, California, United States

Site 02

Plainfield, Indiana, United States

Site 13

Louisville, Kentucky, United States

Site 15

Baton Rouge, Louisiana, United States

Site 09

New Brighton, Minnesota, United States

Site 01

Anderson, South Carolina, United States

Site 06

Greenville, South Carolina, United States

Site 11

Knoxville, Tennessee, United States

Site 03

Arlington, Texas, United States

Site 04

Austin, Texas, United States

Site 10

College Station, Texas, United States

Site 12

Houston, Texas, United States

Site 05

Pflugerville, Texas, United States

Site 14

Norfolk, Virginia, United States

Site 08

Spokane, Washington, United States

Countries

United States

Other Identifiers

250-12951-201

Identifier Type: -

Identifier Source: org_study_id