Four 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 Applied 3 Times Per Week for 4 Weeks for the Treatment of Common Warts in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115141
• Other study ID #: 1513-RESI
• Status: Completed
• Phase: Phase 2
• First received: June 21, 2005
• Last updated: February 16, 2007
• Start date: April 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 four weeks.

A second purpose is to evaluate the safety of the drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• 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 warts, 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

• Warts

Intervention

Drug:
• Resiquimod

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Graceway Pharmaceuticals, LLC

Outcome

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