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Study With a Topical Gel to Treat Common Warts in Adults
This study has been completed.
Sponsored by: Graceway Pharmaceuticals, LLC
Information provided by: Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00117923
  Purpose

The primary purpose of this study is to evaluate the effectiveness in adults of four different strengths of resiquimod gel applied to common wart(s) five 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
Drug Information available for: Resiquimod
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title: A Three-Stage, Modified-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 5 Times Per Week for 4 Weeks for the Treatment of Common Warts in Adults

Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Clearance of treated wart(s)

Secondary Outcome Measures:
  • Partial clearance of treated wart(s)
  • Wart recurrence

Estimated Enrollment: 88
Study Start Date: August 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117923

Locations
United States, Oregon
Oregon Medical Research Center
Portland, Oregon, United States, 97223
Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
  More Information

Study ID Numbers: 1514-RESI
Study First Received: June 30, 2005
Last Updated: February 16, 2007
ClinicalTrials.gov Identifier: NCT00117923  
Health Authority: United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:
Warts
Adults
Common Warts
Resiquimod

Study placed in the following topic categories:
Virus Diseases
Skin Diseases, Infectious
Warts
Skin Diseases
DNA Virus Infections
Papillomavirus Infections

Additional relevant MeSH terms:
Skin Diseases, Viral
Neoplasms
Tumor Virus Infections

ClinicalTrials.gov processed this record on January 14, 2009