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

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ClinicalTrials.gov Identifier: NCT00384124
Recruitment Status : Unknown
Verified March 2008 by Brooke Army Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : October 5, 2006
Last Update Posted : March 26, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Bowens Disease Drug: Imiquimod Phase 2 Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2006
Estimated Primary Completion Date : November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Imiquimod
    Imiquimod application M-F for six weeks (total of 30 applications) followed by surgical excision of site
    Other Name: Aldara

Outcome Measures

Primary Outcome Measures :
  1. histologic clearance of Bowens disease in treated versus placebo group [ Time Frame: 14 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Nicole Owens, MD, Brooke Army Medical Center Department of Dermatology
ClinicalTrials.gov Identifier: NCT00384124     History of Changes
Other Study ID Numbers: C.2005.087
First Posted: October 5, 2006    Key Record Dates
Last Update Posted: March 26, 2008
Last Verified: March 2008

Keywords provided by Brooke Army Medical Center:
Bowens disease
Squamous cell carcinoma in situ of the skin
imiquimod

Additional relevant MeSH terms:
Bowen's Disease
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers