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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brooke Army Medical Center
• Treatments: Imiquimod

Criteria

Inclusion Criteria:

• Histologic diagnosis of Bowen's disease (squamous cell carcinoma in situ), defined as full-thickness keratinocyte atypia and architectural disorder limited to the epidermis, with or without involvement of the follicular unit

• Located on the head and neck, defined as any area superior to the clavicle and anterior to the posterior triangle of the neck

• Primary Bowen's disease (first diagnosis)

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