Topical 5% Imiquimod cream for vulvar Paget's disease: clinical efficacy, safety and immunological response

Completed

Conditions: vulvar extramammary paget's disease
vulvar paget's disease
10047789

Registration Number: NL-OMON42251

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

- Non invasive vulvar Paget's disease, primary or recurrence after previous surgery
- Age 18 and older

Exclusion Criteria

- invasive vulvar Paget's disease
- underlying adenocarcinoma
- previous treatment of the vulva with 5% imiquimod cream during the last 6 months
- patients with autoimmune disorders
- immune compromised patients
- pregnant women
- lactating women

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome is the clinical response to treatment with topical 5%<br /><br>imiquimod cream, defined as a complete remission, partial remission or no<br /><br>remission. Complete remission is defined as disappearance of the lesion and<br /><br>histological confirmation of disappearance. Partial remission is defined as<br /><br>decrease by *50% of total lesion size. No response is defined as <50% decrease<br /><br>of total lesion size.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome is the safety of topical 5% imiquimod cream, assessed by<br /><br>recording all adverse events; immunological response will be assessed by<br /><br>different immunological markers (which are currently studied in a pilot trial)<br /><br>and the quality of life during treatment will be assessed by 3 questionnaires,<br /><br>EQ5D, DLQI and (if applicable) FSDS. </p><br>