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Study With a Topical Gel to Treat Common Warts in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00117871
Recruitment Status : Completed
First Posted : July 11, 2005
Last Update Posted : February 19, 2007
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC

Tracking Information
First Submitted Date  ICMJE June 30, 2005
First Posted Date  ICMJE July 11, 2005
Last Update Posted Date February 19, 2007
Study Start Date  ICMJE October 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2005)
Clearance of treated wart(s)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00117871 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2005)
Partial clearance of treated wart(s)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study With a Topical Gel to Treat Common Warts in Adults
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Warts
Intervention  ICMJE Drug: Resiquimod
Study Arms  ICMJE 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
 (submitted: June 30, 2005)
48
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00117871
Other Study ID Numbers  ICMJE 1515-RESI
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Graceway Pharmaceuticals, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account 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