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
  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:


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 April 16, 2014