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.

Sponsor:

Information provided by:

Graceway Pharmaceuticals, LLC

ClinicalTrials.gov Identifier:

NCT00116662

First received: June 30, 2005

Last updated: February 16, 2007

Last verified: November 2006

History of Changes

Tracking Information
First Received Date ^ICMJE	June 30, 2005
Last Updated Date	February 16, 2007
Start Date ^ICMJE	March 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 30, 2005)	Clearance of treated common wart(s)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00116662 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 30, 2005)	Partial clearance of treated common wart(s) Wart recurrence
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	An up to Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment
Condition ^ICMJE	Warts
Intervention ^ICMJE	Drug: Resiquimod
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	84
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	3 Years to 11 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00116662
Other Study ID Numbers ^ICMJE	1534-RESI
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Graceway Pharmaceuticals, LLC
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Graceway Pharmaceuticals, LLC
Verification Date	November 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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