Topical Imiquimod for Bowen's Disease of the Head and Neck
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|ClinicalTrials.gov Identifier: NCT00384124|
Recruitment Status : Unknown
Verified March 2008 by Brooke Army Medical Center.
Recruitment status was: Enrolling by invitation
First Posted : October 5, 2006
Last Update Posted : March 26, 2008
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Bowens Disease||Drug: Imiquimod||Phase 2 Phase 3|
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
- Previous treatment of biopsied lesion Recurrent lesions from previous biopsy-proven Bowen's disease
- Patients younger than 18 years of age
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||November 2006|
|Estimated Primary Completion Date :||November 2008|
- Drug: Imiquimod
Imiquimod application M-F for six weeks (total of 30 applications) followed by surgical excision of siteOther Name: Aldara
- histologic clearance of Bowens disease in treated versus placebo group [ Time Frame: 14 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384124
|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|