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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00384124 |
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Date of registration:
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04/10/2006 |
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Primary sponsor: |
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Public title:
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Topical Imiquimod for Bowen's Disease of the Head and Neck
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Scientific title:
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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. |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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50 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT00384124 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Nicole M Owens, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Brooke Army Medical Center Department of Dermatology |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bowens Disease
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Intervention(s)
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Drug: Imiquimod
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Primary Outcome(s)
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histologic clearance of Bowens disease in treated versus placebo group
[Time Frame: 14 weeks]
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Secondary ID(s)
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C.2005.087
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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