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

NCT ID: NCT00384124

Last Updated: 2008-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Brief Summary

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* 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

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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

Conditions

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Bowens Disease

Keywords

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Bowens disease Squamous cell carcinoma in situ of the skin imiquimod

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Imiquimod

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

Intervention Type DRUG

Other Intervention Names

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Aldara

Eligibility 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brooke Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Brooke Army Medical Center Department of Dermatology

Principal Investigators

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Nicole M Owens, MD

Role: PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center Department of Dermatology

Locations

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Brooke Army Medical Center Department of Dermatology

Fort Sam Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C.2005.087

Identifier Type: -

Identifier Source: org_study_id