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Sponsored by: |
Brooke Army Medical Center |
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Information provided by: | Brooke Army Medical Center |
ClinicalTrials.gov Identifier: | NCT00384124 |
Condition | Intervention | Phase |
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Bowens Disease |
Drug: Imiquimod |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
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. |
Estimated Enrollment: | 50 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
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:
Lesions larger than 2 cm
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Exclusion Criteria:
United States, Texas | |
Brooke Army Medical Center Department of Dermatology | |
Fort Sam Houston, Texas, United States, 78234 |
Principal Investigator: | Nicole M Owens, MD | Brooke Army Medical Center Department of Dermatology |
Responsible Party: | Brooke Army Medical Center Department of Dermatology ( Nicole Owens, MD ) |
Study ID Numbers: | C.2005.087 |
Study First Received: | October 4, 2006 |
Last Updated: | March 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00384124 History of Changes |
Health Authority: | United States: Federal Government |
Bowens disease Squamous cell carcinoma in situ of the skin imiquimod |
Bowen's Disease Immunologic Factors Carcinoma in Situ Interferons Epidermoid Carcinoma Adjuvants, Immunologic |
Imiquimod Neoplasms, Squamous Cell Squamous Cell Carcinoma Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |
Interferon Inducers Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Adjuvants, Immunologic Imiquimod Pharmacologic Actions |
Carcinoma Bowen's Disease Neoplasms Therapeutic Uses Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |