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.

First Received: June 30, 2005 Last Updated: February 16, 2007 History of Changes

Sponsored by:	Graceway Pharmaceuticals, LLC
Information provided by:	Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:	NCT00116662

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 up to twelve weeks.

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

Condition	Intervention	Phase
Warts	Drug: Resiquimod	Phase II

MedlinePlus related topics: Warts

Drug Information available for: Resiquimod

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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

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

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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116662

Locations

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

Sponsors and Collaborators

Graceway Pharmaceuticals, LLC

More Information

No publications provided

Study ID Numbers:	1534-RESI
Study First Received:	June 30, 2005
Last Updated:	February 16, 2007
ClinicalTrials.gov Identifier:	NCT00116662 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:

Wart(s)
Common Wart(s)
Children

Pediatric
3M Pharmaceuticals
Resiquimod

Study placed in the following topic categories:

Virus Diseases
Skin Diseases, Infectious
Warts

Skin Diseases
DNA Virus Infections
Papillomavirus Infections

Additional relevant MeSH terms:

Skin Diseases, Viral
Virus Diseases
Skin Diseases, Infectious
Neoplasms
Warts

Skin Diseases
Tumor Virus Infections
DNA Virus Infections
Papillomavirus Infections

ClinicalTrials.gov processed this record on May 07, 2009