Exploratory study of imiquimod topical therapy for Bowen's disease
- Conditions
- Bowen disease
- Registration Number
- JPRN-jRCTs041230132
- Lead Sponsor
- Yoshikawa Shusuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 12
(1) Histopathologically diagnosed Bowen's disease on biopsy
(2) Tumor lesion size of 10 mm or greater on the trunk and extremities, excluding lesions on the head and neck, fingernail area, external genitalia, and perianal area.
(3) Obvious neoplastic lesion on pre-registration CT.
(4) Over 18 years old
(5) Written consent to participate in the study has been obtained from the patient
(6) ECOG PS 0-2
(1) Previous topical treatment, cryotherapy, radiation therapy, or post-surgical treatment for Bowen's disease
(2) Multiple Bowen lesions
(3) Strong inflammatory findings
(4) Systemic infection
(5) Difficulty in performing topical treatment as prescribed
(6) Psychiatric illness or psychiatric symptoms that interfere with daily life
(7) On continuous administration of steroids or other immunosuppressive drugs
(8) Patients with a history of hypersensitivity to imiquimod
(9) Patients who are judged to be inappropriate for this study by the treating physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <Efficacy><br>Tumor shrinkage rate at the end of protocol treatment
- Secondary Outcome Measures
Name Time Method <Efficacy><br>Lesion disappearance rate at the end of protocol treatment<br>Local recurrence rate 6 months after completion of protocol treatment<br><Safety><br>Adverse event rate (local skin reaction) up to 6 months after completion of protocol treatment