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

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Bowens Disease

Intervention / Treatment
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* Drug: Imiquimod


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Imiquimod|Imiquimod application M-F for six weeks (total of 30 applications) followed by surgical excision of site|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histologic clearance of Bowens disease in treated versus placebo group |  | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowens disease, Squamous cell carcinoma in situ of the skin, imiquimod