Clinical trial NCT00384124: Topical Imiquimod for Bowen's Disease of the Head and Neck
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Bowens Disease
Keywords: Bowens disease
Squamous cell carcinoma in situ of the skin
imiquimod
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2006-10-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: histologic clearance of Bowens disease in treated versus placebo group
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center Department of Dermatology
state: Texas
Study officials:
affiliation: Brooke Army Medical Center Department of Dermatology
name: Nicole M Owens, MD
role: PRINCIPAL_INVESTIGATOR
References: