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

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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.

Brief 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 Summary:

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

Sponsor: Brooke Army Medical Center

Current Primary Outcome: histologic clearance of Bowens disease in treated versus placebo group [ Time Frame: 14 weeks ]

Original Primary Outcome: histologic clearance of Bowens disease in treated versus placebo group

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Brooke Army Medical Center

Dates:
Date Received: October 4, 2006
Date Started: November 2006
Date Completion:
Last Updated: March 25, 2008
Last Verified: March 2008