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Topical Imiquimod for Bowen's Disease of the Head and Neck

NCT00384124 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2008-03-26

No results posted yet for this study

Summary

* Double blinded, randomized, placebo controlled trial of imiquimod for the treatment of histologically proven Bowens disease of the head and neck.
* Null hypothesis: No difference in histologic clearance rates of patients with head or neck Bowens treated with imiquimod versus placebo.
* Outcome: Histologic clearance of Bowens disease at T=14 weeks.

Conditions

  • Bowens Disease

Interventions

DRUG

Imiquimod

Imiquimod application M-F for six weeks (total of 30 applications) followed by surgical excision of site

Sponsors & Collaborators

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Nicole M Owens, MD · Brooke Army Medical Center Department of Dermatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2008-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00384124 on ClinicalTrials.gov