Study With a Topical Gel to Treat Common Warts in Adults
Primary Purpose
Warts
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Resiquimod
Sponsored by
About this trial
This is an interventional treatment trial for Warts focused on measuring Warts, Adults, Common Warts, Resiquimod
Eligibility Criteria
Inclusion Criteria: Diagnosis of common warts Two forms of birth control Exclusion Criteria: Pregnant or breast feeding Other types of warts, ie. plantar Currently participating in another clinical study Chronic viral hepatitis B or C
Sites / Locations
- Minnesota Clinical Study Center
Outcomes
Primary Outcome Measures
Clearance of treated wart(s)
Secondary Outcome Measures
Partial clearance of treated wart(s)
Full Information
NCT ID
NCT00117871
First Posted
June 30, 2005
Last Updated
February 16, 2007
Sponsor
Graceway Pharmaceuticals, LLC
1. Study Identification
Unique Protocol Identification Number
NCT00117871
Brief Title
Study With a Topical Gel to Treat Common Warts in Adults
Official Title
A Two-Stage, Single-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 5 Times Per Week for up to 12 Weeks for the Treatment of Common Warts in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
October 2004 (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 adults of 2 different strengths of resiquimod gel applied to common wart(s) five times a week for up to 12 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
Warts, Adults, Common Warts, Resiquimod
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
48 (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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of common warts
Two forms of birth control
Exclusion Criteria:
Pregnant or breast feeding
Other types of warts, ie. plantar
Currently participating in another clinical study
Chronic viral hepatitis B or C
Facility Information:
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
12. IPD Sharing Statement
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Study With a Topical Gel to Treat Common Warts in Adults
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