Topical Imiquimod for Bowen's Disease of the Head and Neck

Phase 2

• Conditions: Bowens Disease

• Registration Number: NCT00384124
• Lead Sponsor: Brooke Army Medical Center

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 clearance rates of patients with head or neck Bowens treated with imiquimod versus placebo.

* Outcome: Histologic clearance of Bowens disease at T=14 weeks.

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 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

Study Timeline

• Study First Submitted: 2006-10-04
• Study First Submitted QC: 2006-10-04
• Study First Posted: 2006-10-05
• Study Start: 2006-11
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-25
• Last Update Posted: 2008-03-26
• Primary Completion: 2008-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
histologic clearance of Bowens disease in treated versus placebo group	14 weeks

Trial Locations

Locations (1)

Brooke Army Medical Center Department of Dermatology; 🇺🇸 Fort Sam Houston, Texas, United States