Back to results

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

Primary Purpose

Warts

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Resiquimod

About this trial

This is an interventional treatment trial for Warts focused on measuring Wart(s), Adults, Common Wart(s)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Welborn Clinic

Outcomes

Primary Outcome Measures

Clearance of treated common wart(s)

Secondary Outcome Measures

Partial clearance of treated common wart(s)

Wart recurrence

Full Information

NCT ID

NCT00114920

First Posted

June 20, 2005

Last Updated

February 16, 2007

Sponsor

Graceway Pharmaceuticals, LLC

1. Study Identification

Unique Protocol Identification Number

NCT00114920

Brief Title

Twelve Week Safety and Efficacy 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 for the Treatment of Common Warts in Adults

Study Type

Interventional

2. Study Status

Record Verification Date

November 2006

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Graceway Pharmaceuticals, LLC

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Warts

Keywords

Wart(s), Adults, Common Wart(s)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Single

Allocation

Non-Randomized

Enrollment

88 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Resiquimod

Primary Outcome Measure Information:

Title

Clearance of treated common wart(s)

Secondary Outcome Measure Information:

Title

Partial clearance of treated common wart(s)

Title

Wart recurrence

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Welborn Clinic

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47713

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs