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

NCT ID: NCT00116675

Last Updated: 2007-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Warts

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Resiquimod

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Graceway Pharmaceuticals, LLC

INDUSTRY

Sponsor Role lead

Locations

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Children's Clinic of Jonesboro, PA

Jonesboro, Arkansas, United States

Site Status

University of California - San Francisco

San Francisco, California, United States

Site Status

Longmont Clinic/Longmont Medical Research Network

Longmont, Colorado, United States

Site Status

Mercy Health Research

St Louis, Missouri, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Rhode Island Hospital - Jane Brown Building

Providence, Rhode Island, United States

Site Status

DermResearch, Inc.

Austin, Texas, United States

Site Status

Alpine Pediatrics

Pleasant Grove, Utah, United States

Site Status

Walla Walla Clinic

Walla Walla, Washington, United States

Site Status

Advanced Healthcare

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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1535-RESI

Identifier Type: -

Identifier Source: org_study_id

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