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

Bowens Disease Clinical Trial

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00384124
• Other study ID #: C.2005.087
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: October 4, 2006
• Last updated: March 25, 2008
• Start date: November 2006

Study information

• Verified date: March 2008
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bowen's Disease
• Bowens Disease

Intervention

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

Locations

Country	Name	City	State
United States	Brooke Army Medical Center Department of Dermatology	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	histologic clearance of Bowens disease in treated versus placebo group		14 weeks	No