Exploratory study of imiquimod topical therapy for Bowen's disease

JRCT ID: jRCTs041230132

Registered date:01/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Bowen disease
• Date of first enrollment: 06/11/2024
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Patients with Bowen's disease will be treated with imiquimod 5% applied to the target site 3 times a week before bedtime. Three courses of 3 weekly applications will be repeated for 4 weeks, followed by a 4-week rest period. 4 weeks of application followed by a 4-week rest period will constitute a course of 3 courses.

Outcome(s)

Primary Outcome

<Efficacy>
Tumor shrinkage rate at the end of protocol treatment

Secondary Outcome

<Efficacy>
Lesion disappearance rate at the end of protocol treatment
Local recurrence rate 6 months after completion of protocol treatment
<Safety>
Adverse event rate (local skin reaction) up to 6 months after completion of protocol treatment

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(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

Exclude criteria

(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.

Related Information

• Primary Sponsor: Yoshikawa Shusuke