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Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00116675
Recruitment Status : Completed
First Posted : July 1, 2005
Last Update Posted : February 19, 2007
Information provided by:
Graceway Pharmaceuticals, LLC

Brief Summary:

The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of three different strengths of resiquimod gel applied to common wart(s) three times a week for four weeks.

A second purpose is to evaluate the safety of the drug.

Condition or disease Intervention/treatment Phase
Warts Drug: Resiquimod Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 84 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Single-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 3 Times Per Week for 4 Weeks for the Treatment of Common Warts in Pediatric Subjects
Study Start Date : March 2005
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Primary Outcome Measures :
  1. Clearance of treated wart(s)

Secondary Outcome Measures :
  1. Partial clearance of treated wart(s)
  2. Wart recurrence

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of common warts
  • Ages between 3 to 11

Exclusion Criteria:

  • Other types of wart(s), ie. plantar
  • Currently participating in another clinical study
  • Chronic viral hepatitis B or C

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00116675

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United States, Arkansas
Children's Clinic of Jonesboro, PA
Jonesboro, Arkansas, United States, 72401
United States, California
University of California - San Francisco
San Francisco, California, United States, 94143
United States, Colorado
Longmont Clinic/Longmont Medical Research Network
Longmont, Colorado, United States, 80501
United States, Missouri
Mercy Health Research
St. Louis, Missouri, United States, 63141
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, Rhode Island
Rhode Island Hospital - Jane Brown Building
Providence, Rhode Island, United States, 02903
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
United States, Utah
Alpine Pediatrics
Pleasant Grove, Utah, United States, 84062
United States, Washington
Walla Walla Clinic
Walla Walla, Washington, United States, 99362
United States, Wisconsin
Advanced Healthcare
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
Graceway Pharmaceuticals, LLC

Layout table for additonal information Identifier: NCT00116675     History of Changes
Other Study ID Numbers: 1535-RESI
First Posted: July 1, 2005    Key Record Dates
Last Update Posted: February 19, 2007
Last Verified: June 2006
Keywords provided by Graceway Pharmaceuticals, LLC:
Common Wart(s)
3M Pharmaceuticals
Additional relevant MeSH terms:
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Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases