Topical Imiquimod for Bowen's Disease of the Head and Neck - Full Text View

Sponsored by:	Brooke Army Medical Center
Information provided by:	Brooke Army Medical Center
ClinicalTrials.gov Identifier:	NCT00384124

Purpose

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.

Condition	Intervention	Phase
Bowens Disease	Drug: Imiquimod	Phase II Phase III

Drug Information available for: S 26308

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
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.

Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:

histologic clearance of Bowens disease in treated versus placebo group [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	November 2006
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384124

Locations

United States, Texas
Brooke Army Medical Center Department of Dermatology
Fort Sam Houston, Texas, United States, 78234

Sponsors and Collaborators

Brooke Army Medical Center

Investigators

Principal Investigator:

Nicole M Owens, MD

Brooke Army Medical Center Department of Dermatology

More Information

Responsible Party:	Brooke Army Medical Center Department of Dermatology ( Nicole Owens, MD )
Study ID Numbers:	C.2005.087
Study First Received:	October 4, 2006
Last Updated:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00384124
Health Authority:	United States: Federal Government

Keywords provided by Brooke Army Medical Center:

Bowens disease
Squamous cell carcinoma in situ of the skin
imiquimod

Study placed in the following topic categories:

Epidermoid carcinoma
Bowen's Disease
Squamous cell carcinoma
Carcinoma in Situ
Interferons
Bowen's disease

Carcinoma, squamous cell
Imiquimod
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Interferon Inducers
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 10, 2009