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

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

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 up to twelve weeks.

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

Condition Intervention Phase
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 up to 12 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 common wart(s)

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

Estimated Enrollment: 84
Study Start Date: March 2005

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

Inclusion Criteria:

  • Diagnosis of common wart(s)
  • 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 identifier: NCT00116662

United States, Arkansas
Fayetteville, Arkansas, United States, 72703
Little Rock, Arkansas, United States, 72205
United States, Georgia
Newnan, Georgia, United States, 30263
United States, Illinois
Buffalo Grove, Illinois, United States, 60089
United States, Indiana
Lafayette, Indiana, United States, 47904
United States, Kansas
Wichita, Kansas, United States, 67207
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, Utah
Layton, Utah, United States, 84041
United States, Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
  More Information

No publications provided Identifier: NCT00116662     History of Changes
Other Study ID Numbers: 1534-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)
3M Pharmaceuticals

Additional relevant MeSH terms:
DNA Virus Infections
Papillomavirus Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Tumor Virus Infections
Virus Diseases processed this record on November 27, 2015