Clinical Trial Evaluating Efficacy of Duct Tape for Treatment of Warts

This study has been completed.
Sponsor:
Collaborators:
Minnesota Medical Foundation
Information provided by:
Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00328991
First received: May 22, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Wart
Common Wart
Verruca Vulgaris
Verruca Plantaris
Plantar Wart
Device: duct tape occlusion therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized Control Trial To Evaluate the Efficacy of Duct Tape Versus Placebo for the Treatment of Verruca Vulgaris

Resource links provided by NLM:


Further study details as provided by Minneapolis Veterans Affairs Medical Center:

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.

Estimated Enrollment: 90
Study Start Date: October 2004
Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328991

Locations
United States, Minnesota
Minneapolis Veterans Affairs Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Minnesota Medical Foundation
Investigators
Principal Investigator: Erin M. Warshaw, MD Minneapolis Veterans Affairs Medical Center
  More Information

No publications provided by Minneapolis Veterans Affairs Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00328991     History of Changes
Other Study ID Numbers: 3482-A
Study First Received: May 22, 2006
Last Updated: May 22, 2006
Health Authority: United States: Federal Government

Keywords provided by Minneapolis Veterans Affairs Medical Center:
wart
common wart
verruca vulgaris
verruca plantaris
plantar wart
duct tape
occlusion therapy

Additional relevant MeSH terms:
Warts
Foot Diseases
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 23, 2014