Topical Imiquimod for Bowen's Disease of the Head and Neck | NCT00384124

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

NCT00384124

Sponsor

Brooke Army Medical Center

Status

Unknown status

Last Update Posted

Mar 26, 2008Estimated

Enrollment

50Estimated

Phase

Phase 2Phase 3

Conditions

Bowens Disease

Interventions

Imiquimod

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Nov 2008Estimated

Completion Date

Not provided

First Submitted Date

Oct 4, 2006

First Submission Date that Met QC Criteria

Oct 4, 2006

First Posted Date

Oct 5, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2008

Last Update Posted Date

Mar 26, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imiquimod	Drug	Imiquimod application M-F for six weeks (total of 30 applications) followed by surgical excision of site		Aldara

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
histologic clearance of Bowens disease in treated versus placebo group		14 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicole M Owens, MD	Brooke Army Medical Center Department of Dermatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brooke Army Medical Center Department of Dermatology		Fort Sam Houston	Texas	78234	United States

Condition Browse Module

MeSH Terms

ID	Term
D001913	Bowen's Disease

Ancestor Terms

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077271	Imiquimod

Ancestor Terms

ID	Term
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided