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.
18 Years
N/A
Both
Bowens Disease
Trial Information
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.
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
histologic clearance of Bowens disease in treated versus placebo group
Outcome Time Frame:
14 weeks
Safety Issue:
No
Principal Investigator
Nicole M Owens, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Brooke Army Medical Center Department of Dermatology
Authority:
United States: Federal Government
Study ID:
C.2005.087
NCT ID:
NCT00384124
Start Date:
November 2006
Completion Date:
Related Keywords:
- Bowens Disease
- Bowens disease
- Squamous cell carcinoma in situ of the skin
- imiquimod
- Bowen's Disease
Name | Location |
|---|---|
| Brooke Army Medical Center Department of Dermatology | Fort Sam Houston, Texas 78234 |
