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

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

Study Overview

• Status: Recruiting
• Conditions: Warts; Common Wart; Verruca Vulgaris
• Intervention / Treatment: Drug: VDMN-21 Patch Low Dose; Drug: VDMN-21 Patch High Dose; Drug: Vehicle Patch

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Katie Mateja, MBA; Phone Number: 448-949-1411; Email: kmateja@therapeuticsinc.com

Study Locations

• United States
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Recruiting
      • Site 07
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • Site 16
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Recruiting
      • Site 02
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Recruiting
      • Site 13
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Recruiting
      • Site 15
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Recruiting
      • Site 09
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Recruiting
      • Site 01
    • Greenville, South Carolina, United States, 29615
      • Recruiting
      • Site 06
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Recruiting
      • Site 11
  • Texas
    • Arlington, Texas, United States, 76011
      • Recruiting
      • Site 03
    • Austin, Texas, United States, 78759
      • Recruiting
      • Site 04
    • College Station, Texas, United States, 77845
      • Recruiting
      • Site 10
    • Houston, Texas, United States, 77056
      • Recruiting
      • Site 12
    • Pflugerville, Texas, United States, 78660
      • Recruiting
      • Site 05
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Site 14
  • Washington
    • Spokane, Washington, United States, 99202
      • Recruiting
      • Site 08

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: VDMN-21 Patch Low Dose; Microneedle patch containing 125 mcg of active drug
Experimental: 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).	Drug: VDMN-21 Patch High Dose; Microneedle patch containing 250 mcg of active drug
Placebo Comparator: 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).	Drug: Vehicle Patch; Placebo microneedle patch containing no active drug (i.e., placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Veradermics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts
• Other Study ID Numbers: 250-12951-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No