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:
NCT00117923
First received: June 30, 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) 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 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 5 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: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on October 21, 2014