NCT00384124

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2006

Completed
27 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Last Updated

March 26, 2008

Status Verified

March 1, 2008

Enrollment Period

2 years

First QC Date

October 4, 2006

Last Update Submit

March 25, 2008

Conditions

Bowens Disease

Keywords

Bowens diseaseSquamous cell carcinoma in situ of the skinimiquimod

Outcome Measures

Primary Outcomes (1)

  • histologic clearance of Bowens disease in treated versus placebo group

    14 weeks

Interventions

ImiquimodDRUG

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

Also known as: Aldara

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Center Department of Dermatology

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Conditions

Bowen's Disease

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Nicole M Owens, MD

    Brooke Army Medical Center Department of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

October 4, 2006

First Posted

October 5, 2006

Study Start

November 1, 2006

Primary Completion

November 1, 2008

Last Updated

March 26, 2008

Record last verified: 2008-03

Locations

US(1)