Bowens DiseasePhase 2/3NCT00384124
Topical Imiquimod for Bowen's Disease of the Head and Neck
A Phase 2/3 study testing Imiquimod in people with Bowens Disease, run by Brooke Army Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowens Disease
- What is being tested?
- Imiquimod
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Nov 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center Department of Dermatology
Fort Sam Houston, Texas, 78234
About this study
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.
- 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.
Read the 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
- Conditions
- Bowens Disease
- Being tested
- Imiquimod
- Keywords
- Bowens disease, Squamous cell carcinoma in situ of the skin, imiquimod
- Medical subject headings
- Bowen's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImiquimodDrug
Also called Aldara
Imiquimod application M-F for six weeks (total of 30 applications) followed by surgical excision of site
What is being measured
The primary outcome is the main question the study is designed to answer.
histologic clearance of Bowens disease in treated versus placebo group
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowens DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- Nicole M Owens, MD, Principal investigator, Brooke Army Medical Center Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384124
- Sponsor's protocol ID
- C.2005.087
- Status last verified
- Mar 2008
- First submitted
- 4 Oct 2006
- Last updated
- 26 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00384124
- Acronym / sponsor ID
- C.2005.087
- Conditions
- Bowens Disease
- Keywords
- Bowens disease, Squamous cell carcinoma in situ of the skin, imiquimod
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Nov 2006
- Primary completion
- Nov 2008 (estimated)
- First posted
- 5 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImiquimodAlso: AldaraImiquimod application M-F for six weeks (total of 30 applications) followed by surgical excision of site | Drug | – |
Primary outcome
histologic clearance of Bowens disease in treated versus placebo group
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2008.
Related trials for Bowens Disease
Not yet recruiting
High Intensity Focused Ultrasound vs. Cryotherapy in the Treatment of Basal Cell Carcinomas and Bowen's Disease in Adults
Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole M Owens, MD principal investigator
Brooke Army Medical Center Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Imiquimod in people with Bowens Disease, run by Brooke Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
histologic clearance of Bowens disease in treated versus placebo group (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2008.