search
Back to results

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

Primary Purpose

Warts

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Resiquimod
Sponsored by
Graceway Pharmaceuticals, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Warts focused on measuring Common Wart(s), Pediatric, Wart(s), Children, 3M Pharmaceuticals, Resiquimod

Eligibility Criteria

3 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Clinic of Jonesboro, PA
  • University of California - San Francisco
  • Longmont Clinic/Longmont Medical Research Network
  • Mercy Health Research
  • Dartmouth-Hitchcock Medical Center
  • Rhode Island Hospital - Jane Brown Building
  • DermResearch, Inc.
  • Alpine Pediatrics
  • Walla Walla Clinic
  • Advanced Healthcare

Outcomes

Primary Outcome Measures

Clearance of treated wart(s)

Secondary Outcome Measures

Partial clearance of treated wart(s)
Wart recurrence

Full Information

First Posted
June 30, 2005
Last Updated
February 16, 2007
Sponsor
Graceway Pharmaceuticals, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT00116675
Brief Title
Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Graceway Pharmaceuticals, LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warts
Keywords
Common Wart(s), Pediatric, Wart(s), Children, 3M Pharmaceuticals, Resiquimod

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
84 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Resiquimod
Primary Outcome Measure Information:
Title
Clearance of treated wart(s)
Secondary Outcome Measure Information:
Title
Partial clearance of treated wart(s)
Title
Wart recurrence

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Children's Clinic of Jonesboro, PA
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
University of California - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Longmont Clinic/Longmont Medical Research Network
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Mercy Health Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Rhode Island Hospital - Jane Brown Building
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Alpine Pediatrics
City
Pleasant Grove
State/Province
Utah
ZIP/Postal Code
84062
Country
United States
Facility Name
Walla Walla Clinic
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Advanced Healthcare
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs