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

Warts Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05799157
• Other study ID #: 250-12951-201
• Status: Recruiting
• Phase: Phase 2
• Start date: February 28, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Veradermics, Inc.
• Contact: Katie Mateja, MBA
• Phone: 448-949-1411
• Email: kmateja[@]therapeuticsinc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subject is a male or non-pregnant female, 12 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 has received a Human Papilloma Virus (HPV) vaccine within 24 weeks of Baseline.

• 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.

Related Conditions & MeSH terms

• Common Wart
• Verruca Vulgaris
• Warts

Intervention

Drug:
• VDMN-21 Patch Low Dose
Microneedle patch containing 125 mcg of active drug
• VDMN-21 Patch High Dose
Microneedle patch containing 250 mcg of active drug
• Vehicle Patch
Placebo microneedle patch containing no active drug (i.e., placebo)

Locations

Country	Name	City	State
United States	Site 01	Anderson	South Carolina
United States	Site 03	Arlington	Texas
United States	Site 04	Austin	Texas
United States	Site 15	Baton Rouge	Louisiana
United States	Site 10	College Station	Texas
United States	Site 07	Fort Smith	Arkansas
United States	Site 06	Greenville	South Carolina
United States	Site 12	Houston	Texas
United States	Site 11	Knoxville	Tennessee
United States	Site 13	Louisville	Kentucky
United States	Site 09	New Brighton	Minnesota
United States	Site 14	Norfolk	Virginia
United States	Site 05	Pflugerville	Texas
United States	Site 02	Plainfield	Indiana
United States	Site 16	San Diego	California
United States	Site 08	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Veradermics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of subjects with complete clinical resolution of Target Lesion by visit		Days 22, 43, 64, 85, 106, and 134
Other	Proportion of subjects with complete clinical resolution of all the Non-Target Lesion(s) by visit		Days 22, 43, 64, 85, 106, and 134
Primary	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