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NCT00116675 Clinical Trial

Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects

Warts Clinical Trial

Official title:
A Single-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 Pediatric Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00116675
Other study ID # 1535-RESI
Secondary ID
Status Completed
Phase Phase 2
First received June 30, 2005
Last updated February 16, 2007
Start date March 2005
Est. completion date April 2006

Study information
Verified date June 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 pediatric subjects of three 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 84
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 11 Years
Eligibility Inclusion Criteria:

- Diagnosis of common warts

- Ages between 3 to 11

Exclusion Criteria:

- 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 DermResearch, Inc. Austin Texas
United States Children's Clinic of Jonesboro, PA Jonesboro Arkansas
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Longmont Clinic/Longmont Medical Research Network Longmont Colorado
United States Advanced Healthcare Milwaukee Wisconsin
United States Alpine Pediatrics Pleasant Grove Utah
United States Rhode Island Hospital - Jane Brown Building Providence Rhode Island
United States University of California - San Francisco San Francisco California
United States Mercy Health Research St. Louis Missouri
United States Walla Walla Clinic Walla Walla Washington

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 wart(s)
Secondary Partial clearance of treated wart(s)
Secondary Wart recurrence
See also
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Completed NCT02393417 - Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris) Phase 2
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Completed NCT00116662 - An up to Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects Phase 2
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