Status:
UNKNOWN
Topical Imiquimod for Bowen's Disease of the Head and Neck
Lead Sponsor:
Brooke Army Medical Center
Conditions:
Bowens Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 clear...
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 ant...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00384124
Start Date
November 1 2006
Last Update
March 26 2008
Active Locations (1)
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1
Brooke Army Medical Center Department of Dermatology
Fort Sam Houston, Texas, United States, 78234