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

This study has been completed.
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00116675
First received: June 30, 2005
Last updated: February 16, 2007
Last verified: June 2006
  Purpose

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 Intervention Phase
Warts
Drug: Resiquimod
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Clearance of treated wart(s)

Secondary Outcome Measures:
  • Partial clearance of treated wart(s)
  • Wart recurrence

Estimated Enrollment: 84
Study Start Date: March 2005
Estimated Study Completion Date: April 2006
  Eligibility

Ages Eligible for Study:   3 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116675

Locations
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00116675     History of Changes
Other Study ID Numbers: 1535-RESI
Study First Received: June 30, 2005
Last Updated: February 16, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:
Common Wart(s)
Pediatric
Wart(s)
Children
3M Pharmaceuticals
Resiquimod

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

ClinicalTrials.gov processed this record on August 21, 2014