Expired Study
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Portland, Oregon 97223


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.


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


Study is Available At:


Original ID:

1514-RESI


NCT ID:

NCT00117923


Secondary ID:


Study Acronym:


Brief Title:

Study With a Topical Gel to Treat Common Warts in Adults


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Graceway Pharmaceuticals, LLC


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

88


Enrollment Type:


Study Dates

Start Date:August 2004
Verification Date:November 2006
Last Changed Date:February 16, 2007
First Received Date:June 30, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Wart recurrence
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Partial clearance of treated wart(s)
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Clearance of treated wart(s)
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Resiquimod

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Graceway Pharmaceuticals, LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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