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


N/A
18 Years
N/A
Not Enrolling
Both
Wart, Common Wart, Verruca Vulgaris, Verruca Plantaris, Plantar Wart

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Trial Information

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


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.


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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Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

100% resolution of target wart

Principal Investigator

Erin M. Warshaw, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Minneapolis Veterans Affairs Medical Center

Authority:

United States: Federal Government

Study ID:

3482-A

NCT ID:

NCT00328991

Start Date:

October 2004

Completion Date:

December 2005

Related Keywords:

  • Wart
  • Common Wart
  • Verruca Vulgaris
  • Verruca Plantaris
  • Plantar Wart
  • wart
  • common wart
  • verruca vulgaris
  • verruca plantaris
  • plantar wart
  • duct tape
  • occlusion therapy
  • Warts
  • Foot Diseases

Name

Location

Minneapolis Veterans Affairs Medical Center Minneapolis, Minnesota  55417