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


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Warts

Plantar Warts


Clinical Trial: Four Week Safety and Efficacy Study with a Topical Gel to Treat Common Warts in Pediatric Subjects

This study is currently recruiting patients.

Sponsored by: 3M Pharmaceuticals
Information provided by: 3M Pharmaceuticals

Purpose

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.

Condition Intervention Phase
Warts
 Drug: Resiquimod
Phase II

MedlinePlus related topics:  Warts

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: Clearance of treated wart(s)
Secondary Outcomes: Partial clearance of treated wart(s); Wart recurrence
Expected Total Enrollment:  84

Study start: March 2005;  Expected completion: December 2006
Last follow-up: May 2006;  Data entry closure: July 2006

Eligibility

Ages Eligible for Study:  3 Years   -   11 Years,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00116675

Praxis      1-800-606-9278    www.SunshineStudy.com

Missouri
      Mercy Health Research, St. Louis,  Missouri,  63141,  United States; Recruiting
Elaine C. Siegfried, MD  314-251-8890 
Leah McQuality, RN  314-251-8890    mcqulk@stlo.mercy.net 

Study chairs or principal investigators

Elaine C. Siegfried, MD,  Principal Investigator,  Mercy Health Research   

More Information

Study ID Numbers:  1535-RESI
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 30, 2005
ClinicalTrials.gov Identifier:  NCT00116675
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05


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October 7, 2008



Page Updated: May 11, 2006
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