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.”

- 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: November 2008

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

Intervention(s) in this Clinical Trial

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

Primary Measures

• histologic clearance of Bowens disease in treated versus placebo group
  • Time Frame: 14 weeks
    Safety Issue?: 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
• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Brooke Army Medical Center

Overall Clinical Trial Officials and Contacts

Nicole M Owens, MD Principal Investigator Brooke Army Medical Center Department of Dermatology  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00384124

Study ID Number: C.2005.087

ClinicalTrials.gov Identifier: NCT00384124

Health Authority: United States: Federal Government