Trial Title:
Safety and Efficacy of VDMN-21 Patch in Subjects With Common Warts
NCT ID:
NCT05799157
Condition:
Verruca Vulgaris
Warts
Common Wart
Conditions: Official terms:
Warts
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
VDMN-21 Patch Low Dose
Description:
Microneedle patch containing 125 mcg of active drug
Arm group label:
Treatment Group A (Low Dose)
Intervention type:
Drug
Intervention name:
VDMN-21 Patch High Dose
Description:
Microneedle patch containing 250 mcg of active drug
Arm group label:
Treatment Group B (High Dose)
Intervention type:
Drug
Intervention name:
Vehicle Patch
Description:
Placebo microneedle patch containing no active drug (i.e., placebo)
Arm group label:
Treatment Group C (Vehicle)
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).
Criteria for 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.
Gender:
All
Minimum age:
9 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Site 07
Address:
City:
Fort Smith
Zip:
72916
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 16
Address:
City:
San Diego
Zip:
92123
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 02
Address:
City:
Plainfield
Zip:
46168
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 13
Address:
City:
Louisville
Zip:
40241
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 15
Address:
City:
Baton Rouge
Zip:
70809
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 09
Address:
City:
New Brighton
Zip:
55112
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 01
Address:
City:
Anderson
Zip:
29621
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 06
Address:
City:
Greenville
Zip:
29615
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 11
Address:
City:
Knoxville
Zip:
37909
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 03
Address:
City:
Arlington
Zip:
76011
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 04
Address:
City:
Austin
Zip:
78759
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 10
Address:
City:
College Station
Zip:
77845
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 12
Address:
City:
Houston
Zip:
77056
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 05
Address:
City:
Pflugerville
Zip:
78660
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 14
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Recruiting
Facility:
Name:
Site 08
Address:
City:
Spokane
Zip:
99202
Country:
United States
Status:
Recruiting
Start date:
February 28, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Veradermics, Inc.
Agency class:
Industry
Source:
Veradermics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05799157
