NCT00384124

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

Phase III Trial of 6 Weeks of Imiquimod for the Treatment of Bowens Disease of the Head and Neck. Outcome is Histologic Clearance at 14 Weeks.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Brooke Army Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Interventional study Enrolling Inclusion criteria: Military beneficiaries with histologically proven Bowens disease, located on the head and neck, defined as any area superior to the clavicle and anterior to the posterior triangle of the neck Exclusion Criteria: * Previous treatment of biopsied lesion Recurrent lesions from previous biopsy-proven Bowen's disease * Patients younger than 18 years of age * Pregnancy * Immunosuppression, including HIV, transplant patients on immune suppressive medications, cancer patients on chemotherapy, and hematologic malignancies (e.g., lymphoma, leukemia) * Mucous membrane involvement * Lesions larger than 2 cm * Methods: Pts randomized to treatment group (6 weeks of Mon-Friday Imiquimod to Bowens site) or vehicle group (same treatment regimen). All patients undergo surgical excision (Mohs or simple excision) of site where disease is either visible or was present and tissue examined for histologic evidence of residual Bowens disease

Conditions

• Bowens Disease

Interventions

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

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-11-01
• First posted: 2006-10-05
• Last updated: 2008-03-26

Locations

1 site across 1 country: United States