NCT00116662

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 up to twelve weeks. A second purpose is to evaluate the safety of the drug.

Trial Health

80
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

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

Click on a node to explore related trials.

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
Last Updated

February 19, 2007

Status Verified

November 1, 2006

First QC Date

June 30, 2005

Last Update Submit

February 16, 2007

Conditions

Keywords

Wart(s)Common Wart(s)ChildrenPediatric3M PharmaceuticalsResiquimod

Outcome Measures

Primary Outcomes (1)

  • Clearance of treated common wart(s)

Secondary Outcomes (2)

  • Partial clearance of treated common 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 wart(s)
  • 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)

Arkansas

Fayetteville, Arkansas, 72703, United States

Location

Arkansas

Little Rock, Arkansas, 72205, United States

Location

Georgia

Newnan, Georgia, 30263, United States

Location

Illinois

Buffalo Grove, Illinois, 60089, United States

Location

Indiana

Lafayette, Indiana, 47904, United States

Location

Kansas

Wichita, Kansas, 67207, United States

Location

Massachusetts

Boston, Massachusetts, 02114, United States

Location

Missouri

St Louis, Missouri, 63110, United States

Location

Utah

Layton, Utah, 84041, United States

Location

Vermont

Burlington, Vermont, 05401, 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

Last Updated

February 19, 2007

Record last verified: 2006-11

Locations