NCT00116675

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

February 19, 2007

Status Verified

June 1, 2006

First QC Date

June 30, 2005

Last Update Submit

February 16, 2007

Conditions

Keywords

Common Wart(s)PediatricWart(s)Children3M PharmaceuticalsResiquimod

Outcome Measures

Primary Outcomes (1)

  • Clearance of treated wart(s)

Secondary Outcomes (2)

  • Partial clearance of treated wart(s)

  • Wart recurrence

Interventions

Eligibility Criteria

Age3 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of common warts
  • Ages between 3 to 11

You may not qualify if:

  • Other types of wart(s), ie. plantar
  • Currently participating in another clinical study
  • Chronic viral hepatitis B or C

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Children's Clinic of Jonesboro, PA

Jonesboro, Arkansas, 72401, United States

Location

University of California - San Francisco

San Francisco, California, 94143, United States

Location

Longmont Clinic/Longmont Medical Research Network

Longmont, Colorado, 80501, United States

Location

Mercy Health Research

St Louis, Missouri, 63141, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Rhode Island Hospital - Jane Brown Building

Providence, Rhode Island, 02903, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Alpine Pediatrics

Pleasant Grove, Utah, 84062, United States

Location

Walla Walla Clinic

Walla Walla, Washington, 99362, United States

Location

Advanced Healthcare

Milwaukee, Wisconsin, 53209, United States

Location

MeSH Terms

Conditions

Warts

Interventions

resiquimod

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 1, 2005

Study Start

March 1, 2005

Study Completion

April 1, 2006

Last Updated

February 19, 2007

Record last verified: 2006-06

Locations