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NCT00114920 Clinical Trial

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

Warts Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00114920
Other study ID # 1508-RESI
Secondary ID
Status Completed
Phase Phase 2
First received June 20, 2005
Last updated February 16, 2007
Start date March 2004

Study information
Verified date November 2006
Source Graceway Pharmaceuticals, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Resiquimod

Locations
Country Name City State
United States Welborn Clinic Evansville Indiana

Sponsors (1)
Lead Sponsor Collaborator
Graceway Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clearance of treated common wart(s)
Secondary Partial clearance of treated common wart(s)
Secondary Wart recurrence
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