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An up to Twelve 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 Wart(s), Common Wart(s), Children, Pediatric, 3M Pharmaceuticals, Resiquimod

Eligibility Criteria

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

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

Sites / Locations

  • Arkansas
  • Arkansas
  • Georgia
  • Illinois
  • Indiana
  • Kansas
  • Massachusetts
  • Missouri
  • Utah
  • Vermont

Outcomes

Primary Outcome Measures

Clearance of treated common wart(s)

Secondary Outcome Measures

Partial clearance of treated common wart(s)
Wart recurrence

Full Information

First Posted
June 30, 2005
Last Updated
February 16, 2007
Sponsor
Graceway Pharmaceuticals, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00116662
Brief Title
An up to Twelve 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 up to 12 Weeks for the Treatment of Common Warts in Pediatric Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (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 up to twelve 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
Wart(s), Common Wart(s), Children, Pediatric, 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 common wart(s)
Secondary Outcome Measure Information:
Title
Partial clearance of treated common 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 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
Facility Information:
Facility Name
Arkansas
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Georgia
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Illinois
City
Buffalo Grove
State/Province
Illinois
ZIP/Postal Code
60089
Country
United States
Facility Name
Indiana
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47904
Country
United States
Facility Name
Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Massachusetts
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Missouri
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Utah
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

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

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