Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Prevention, Treatment Enrolling by invitation 18 and over Other C.2005.087 NCT00384124

Trial Description

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.

Further Study Information

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

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Brooke Army Medical Center

Nicole M Owens, MD

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00384124
Information obtained from ClinicalTrials.gov on July 16, 2008