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

February 16, 2007 updated by: Graceway Pharmaceuticals, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clearance of treated wart(s)

Secondary Outcome Measures

Outcome Measure
Partial clearance of treated wart(s)
Wart recurrence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Graceway Pharmaceuticals, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion

April 1, 2006

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

June 30, 2005

First Posted (Estimate)

July 1, 2005

Study Record Updates

Last Update Posted (Estimate)

February 19, 2007

Last Update Submitted That Met QC Criteria

February 16, 2007

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1535-RESI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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