Bowens Disease Clinical Trial
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.
- 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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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