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

Information source: Brooke Army Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bowens Disease

Intervention: Imiquimod (Drug)

Phase: Phase 2/Phase 3

Status: Enrolling by invitation

Sponsored by: Brooke Army Medical Center

Official(s) and/or principal investigator(s):
Nicole M Owens, MD, Principal Investigator, Affiliation: Brooke Army Medical Center Department of Dermatology

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.

Clinical Details

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

Primary outcome: histologic clearance of Bowens disease in treated versus placebo group

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Brooke Army Medical Center Department of Dermatology, Fort Sam Houston, Texas 78234, United States
Additional Information

Starting date: November 2006
Last updated: March 25, 2008

Page last updated: August 23, 2015

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