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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

Brooke Army Medical Center

ClinicalTrials.gov Identifier:

NCT00384124

First received: October 4, 2006

Last updated: March 25, 2008

Last verified: March 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

October 4, 2006

Last Updated Date

March 25, 2008

Start Date ^ICMJE

November 2006

Estimated Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

histologic clearance of Bowens disease in treated versus placebo group

Change History

Complete list of historical versions of study NCT00384124 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Bowens Disease

Intervention ^ICMJE

Drug: Imiquimod

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

Other Name: Aldara

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00384124

Other Study ID Numbers ^ICMJE

C.2005.087

Has Data Monitoring Committee

Yes

Responsible Party

Nicole Owens, MD, Brooke Army Medical Center Department of Dermatology

Study Sponsor ^ICMJE

Brooke Army Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Nicole M Owens, MD

Brooke Army Medical Center Department of Dermatology

Information Provided By

Brooke Army Medical Center

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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