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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

October 4, 2006
March 25, 2008
November 2006
November 2008   (final data collection date for primary outcome measure)
histologic clearance of Bowens disease in treated versus placebo group [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
histologic clearance of Bowens disease in treated versus placebo group
Complete list of historical versions of study NCT00384124 on ClinicalTrials.gov Archive Site
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Topical Imiquimod for Bowen's Disease of the Head and Neck
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.
  • 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.

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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bowens Disease
Drug: Imiquimod
Imiquimod application M-F for six weeks (total of 30 applications) followed by surgical excision of site
Other Name: Aldara
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
Not Provided
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00384124
C.2005.087
Yes
Nicole Owens, MD, Brooke Army Medical Center Department of Dermatology
Brooke Army Medical Center
Not Provided
Principal Investigator: Nicole M Owens, MD Brooke Army Medical Center Department of Dermatology
Brooke Army Medical Center
March 2008

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