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

Primary Purpose

Verruca Vulgaris, Warts, Common Wart

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VDMN-21 Patch Low Dose
VDMN-21 Patch High Dose
Vehicle Patch
Sponsored by
Veradermics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Verruca Vulgaris

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject is a male or non-pregnant female, 18 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 LASER, light or other energy-based therapy (e.g., intense pulsed light [IPL], PDT; 12 weeks Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester [SADBE], etc.), retinoids, hydrogen peroxide; 12 weeks 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 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.

Sites / Locations

  • Site 02Recruiting
  • Site 01Recruiting
  • Site 06
  • Site 03
  • Site 04Recruiting
  • Site 05Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Treatment Group A (Low Dose)

Treatment Group B (High Dose)

Treatment Group C (Vehicle)

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 22, 2023
Last Updated
March 22, 2023
Sponsor
Veradermics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05799157
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veradermics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Verruca Vulgaris, Warts, Common Wart

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group A (Low Dose)
Arm Type
Experimental
Arm Description
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).
Arm Title
Treatment Group B (High Dose)
Arm Type
Experimental
Arm Description
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).
Arm Title
Treatment Group C (Vehicle)
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
VDMN-21 Patch Low Dose
Intervention Description
Microneedle patch containing 125 mcg of active drug
Intervention Type
Drug
Intervention Name(s)
VDMN-21 Patch High Dose
Intervention Description
Microneedle patch containing 250 mcg of active drug
Intervention Type
Drug
Intervention Name(s)
Vehicle Patch
Intervention Description
Placebo microneedle patch containing no active drug (i.e., placebo)
Primary Outcome Measure Information:
Title
Proportion of subjects with complete clinical resolution of the Target Lesion at end of treatment period
Description
Complete clinical resolution is defined as the target lesion with area = 0.
Time Frame
Baseline up to Day 134
Other Pre-specified Outcome Measures:
Title
Proportion of subjects with complete clinical resolution of Target Lesion by visit
Time Frame
Days 22, 43, 64, 85, 106, and 134
Title
Proportion of subjects with complete clinical resolution of all the Non-Target Lesion(s) by visit
Time Frame
Days 22, 43, 64, 85, 106, and 134

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is a male or non-pregnant female, 18 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 LASER, light or other energy-based therapy (e.g., intense pulsed light [IPL], PDT; 12 weeks Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester [SADBE], etc.), retinoids, hydrogen peroxide; 12 weeks 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Weaver, MSCRM
Phone
520-965-7545
Email
eweaver@therapeuticsinc.com
Facility Information:
Facility Name
Site 02
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 01
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 06
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Site 03
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Site 04
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 05
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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