Twelve Week Safety and Efficacy 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:	NCT00114920

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 twelve 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 for the Treatment of Common Warts in Adults

Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:

Clearance of treated common wart(s)

Secondary Outcome Measures:

Partial clearance of treated common wart(s)
Wart recurrence

Estimated Enrollment:	88
Study Start Date:	March 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 wart(s), 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: NCT00114920

Locations

United States, Indiana
Welborn Clinic
Evansville, Indiana, United States, 47713

Sponsors and Collaborators

Graceway Pharmaceuticals, LLC

More Information

Study ID Numbers:	1508-RESI
Study First Received:	June 20, 2005
Last Updated:	February 16, 2007
ClinicalTrials.gov Identifier:	NCT00114920
Health Authority:	United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:

Wart(s)
Adults
Common Wart(s)

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 16, 2009