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Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Adults

This study has been completed.
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00115141
First received: June 21, 2005
Last updated: February 16, 2007
Last verified: November 2006
History of Changes
  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) 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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Three-Stage, Modified-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 Adults

Resource links provided by NLM:

MedlinePlus related topics: Warts
U.S. FDA Resources

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: April 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
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00115141     History of Changes
Other Study ID Numbers: 1513-RESI
Study First Received: June 21, 2005
Last Updated: February 16, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:
Wart(s)
Adults
Common Wart(s)

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
 Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on June 17, 2013