Clinical Trial Evaluating Efficacy of Duct Tape for Treatment of Warts

Double-Blind, Randomized Control Trial To Evaluate the Efficacy of Duct Tape Versus Placebo for the Treatment of Verruca Vulgaris

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.

Study Overview

• Status: Completed
• Conditions: Plantar Wart; Wart; Common Wart; Verruca Vulgaris; Verruca Plantaris
• Intervention / Treatment: Device: duct tape occlusion therapy

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.

• Study Type: Interventional
• Enrollment: 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis Veterans Affairs Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
100% resolution of target wart

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Minneapolis Veterans Affairs Medical Center
• Collaborators: Minnesota Medical Foundation
• Investigators: Principal Investigator: Erin M. Warshaw, MD, Minneapolis Veterans Affairs Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion: December 7, 2022
• Study Completion: December 1, 2005

Study Registration Dates

• First Submitted: May 22, 2006
• First Submitted That Met QC Criteria: May 22, 2006
• First Posted (Estimate): May 24, 2006

Study Record Updates

• Last Update Posted (Estimate): May 24, 2006
• Last Update Submitted That Met QC Criteria: May 22, 2006
• Last Verified: January 1, 2006

More Information

Terms related to this study

• Keywords: wart; common wart; verruca vulgaris; verruca plantaris; plantar wart; duct tape; occlusion therapy
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts
• Other Study ID Numbers: 3482-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No