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

Brooke Army Medical Center

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Bowens Disease

Treatments

Drug: Imiquimod

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00384124

C.2005.087

Details and patient eligibility

About

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.

Full 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

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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