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

Status unconfirmed · Phase 2/Phase 3

Conditions studied: Bowens Disease

In brief

* 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.

Key facts

Study ID

NCT00384124

Run by

Brooke Army Medical Center

People needed

50

Starts

2006-11-01

Last updated by the study team

2008-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Brooke Army Medical Center Department of Dermatology — Fort Sam Houston, Texas, United States

Full record on ClinicalTrials.gov

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