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Clinical Trial Evaluating Efficacy of Duct Tape for Treatment of Warts

Primary Purpose

Wart, Common Wart, Verruca Vulgaris

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
duct tape occlusion therapy
Sponsored by
Minneapolis Veterans Affairs Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wart focused on measuring wart, common wart, verruca vulgaris, verruca plantaris, plantar wart, duct tape, occlusion therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:1) ability to comprehend and provide informed consent; 2) age greater than 18 years old; and 3) at least one common wart, measuring 2-15 millimeters in diameter. Exclusion Criteria: 1) pregnant or lactating females; 2) treatment of the target wart within the past four weeks by any modality; 3) immunodeficiency state (cancer chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.); 4) genital wart only; 5) a history of hypersensitivity or allergy to adhesive tape; 6) documented allergy to latex; and/or 7) participation in another interventional study or use of any investigational drug within 30 days prior to enrollment. -

Sites / Locations

  • Minneapolis Veterans Affairs Medical Center

Outcomes

Primary Outcome Measures

100% resolution of target wart

Secondary Outcome Measures

Change in size of target wart and recurrence of target wart at 6 months.

Full Information

First Posted
May 22, 2006
Last Updated
May 22, 2006
Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
Minnesota Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00328991
Brief Title
Clinical Trial Evaluating Efficacy of Duct Tape for Treatment of Warts
Official Title
Double-Blind, Randomized Control Trial To Evaluate the Efficacy of Duct Tape Versus Placebo for the Treatment of Verruca Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
Minnesota Medical Foundation

4. Oversight

5. Study Description

Brief Summary
This study is a double-blinded, controlled clinical intervention trial to evaluate the efficacy of duct tape occlusions therapy for the treatment of common warts. 80 patients completed this study, and were randomized 1:1 to receive pads which contained either moleskin+transparent duct tape or moleskin alone. The patients wore the pad over the target wart for 7 days at a time, removed the pad on the evening of the 7th day, and replaced the pad on the 8th day. This cycle was repeated for 8 weeks or until the wart resolved. The hypothesis was that duct tape occlusion therapy would be more therapeutic than moleskin for the treatment of the common wart. However, in our study there was only 21% resolution rate in the duct tape arm vs. 22% in the control group.
Detailed Description
ABSTRACT (233 word count) Objective: To evaluate the efficacy of duct tape occlusion therapy for the treatment of common warts. Design: A double-blinded, controlled, clinical intervention trial. Setting: Veterans Affairs Medical Center. Participants: A total of 90 immunocompetent adult volunteers with at least one wart measuring between 2-15 mm were enrolled in this study between October 2004 and July 2005; 80 patients completed the study. Intervention: Patients were randomized using a computer-generated code to receive either pads consisting of moleskin with transparent duct tape (active) or moleskin alone (control). Patients were instructed to wear the pads for 7 consecutive days and leave the pad off on the 7th evening. This process was repeated for 2 months or until the wart resolved, whichever occurred first. Follow-up visits occurred at 1 and 2 months. Main Outcome Measure: 100% resolution of the wart. Secondary outcomes included change in size of the target wart and recurrence rates at 6 months for warts with complete resolution. Results: There were no statistically significant differences in the proportions of patients with resolution of the target wart (duct tape=8/39, 21% vs. control=9/41, 22%). Of patients with complete resolution, 75% (6/8) in the duct tape group and 33% (3/9) of those in the control group had recurrence of the target wart by the sixth month. Conclusions: Occlusive therapy with transparent duct tape is not significantly better than moleskin alone for treatment of common warts in adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wart, Common Wart, Verruca Vulgaris, Verruca Plantaris, Plantar Wart
Keywords
wart, common wart, verruca vulgaris, verruca plantaris, plantar wart, duct tape, occlusion therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
90 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
duct tape occlusion therapy
Primary Outcome Measure Information:
Title
100% resolution of target wart
Secondary Outcome Measure Information:
Title
Change in size of target wart and recurrence of target wart at 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:1) ability to comprehend and provide informed consent; 2) age greater than 18 years old; and 3) at least one common wart, measuring 2-15 millimeters in diameter. Exclusion Criteria: 1) pregnant or lactating females; 2) treatment of the target wart within the past four weeks by any modality; 3) immunodeficiency state (cancer chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.); 4) genital wart only; 5) a history of hypersensitivity or allergy to adhesive tape; 6) documented allergy to latex; and/or 7) participation in another interventional study or use of any investigational drug within 30 days prior to enrollment. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin M. Warshaw, MD
Organizational Affiliation
Minneapolis Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis Veterans Affairs Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17372095
Citation
Wenner R, Askari SK, Cham PM, Kedrowski DA, Liu A, Warshaw EM. Duct tape for the treatment of common warts in adults: a double-blind randomized controlled trial. Arch Dermatol. 2007 Mar;143(3):309-13. doi: 10.1001/archderm.143.3.309.
Results Reference
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Clinical Trial Evaluating Efficacy of Duct Tape for Treatment of Warts

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