Clinical trial NCT05799157: Safety and Efficacy of VDMN-21 Patch in Subjects With Common Warts
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Verruca Vulgaris
Warts
Common Wart
Lead sponsor: Veradermics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-05
Enrollment: 153
Sex: ALL
Minimum age (years): 9
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Proportion of subjects with complete clinical resolution of the Target Lesion at end of treatment period
timeFrame: Baseline up to Day 134
Secondary outcomes:
Other outcomes:
measure: Proportion of subjects with complete clinical resolution of Target Lesion by visit
timeFrame: Days 22, 43, 64, 85, 106, and 134
measure: Proportion of subjects with complete clinical resolution of all the Non-Target Lesion(s) by visit
timeFrame: Days 22, 43, 64, 85, 106, and 134
Locations:
city: Fort Smith
country: United States
facility: Site 07
state: Arkansas
city: San Diego
country: United States
facility: Site 16
state: California
city: Plainfield
country: United States
facility: Site 02
state: Indiana
city: Louisville
country: United States
facility: Site 13
state: Kentucky
city: Baton Rouge
country: United States
facility: Site 15
state: Louisiana
city: New Brighton
country: United States
facility: Site 09
state: Minnesota
city: Anderson
country: United States
facility: Site 01
state: South Carolina
city: Greenville
country: United States
facility: Site 06
state: South Carolina
city: Knoxville
country: United States
facility: Site 11
state: Tennessee
city: Arlington
country: United States
facility: Site 03
state: Texas
city: Austin
country: United States
facility: Site 04
state: Texas
city: College Station
country: United States
facility: Site 10
state: Texas
city: Houston
country: United States
facility: Site 12
state: Texas
city: Pflugerville
country: United States
facility: Site 05
state: Texas
city: Norfolk
country: United States
facility: Site 14
state: Virginia
city: Spokane
country: United States
facility: Site 08
state: Washington
Study officials:
References: