Topical 5% Imiquimod Cream for Vulvar Paget's Disease: Clinical Efficacy, Safety and Immunological Response
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 7
- 主要终点
- Clinical response
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and immunological response of topical 5% imiquimod cream for non-invasive vulvar Paget's disease.
详细描述
Vulvar Paget's disease is a rare skin tumour and generally seen in postmenopausal, Caucasian women as an erythematous, eczematous, scaling or ulcerating plaque. Initial symptoms are irritation, burning, pain and a skin lesion. The origin of vulvar Paget's disease is not yet entirely understood. The treatment of choice is surgical excision, despite high recurrence rates. The mutilating consequences of surgery can lead to impressive morbidity to address this, several series report the use of topical 5% imiquimod cream for vulvar Paget's disease.
The objective of this study is to assess the efficacy, evaluate the safety, immunological effect of topical 5% imiquimod cream for vulvar Paget's disease and the quality of life during treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Non-invasive vulvar Paget's disease, primary or recurrence after earlier surgery;
- •Willing and able to comply with the protocol and to provide informed consent in accordance with institutional and regulatory guidelines.
排除标准
- •Invasive vulvar Paget's disease;
- •Underlying adenocarcinoma;
- •Treatment of the vulva with topical 5% imiquimod cream during the last 6 months;
- •Participation in a study with another investigational product within 30 days prior to enrolment in this study;
- •Hypersensitivity to any component of topical 5% imiquimod cream (methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cetylalcohol, atearylalcohol);
- •Patients with autoimmune disorders;
- •Immune compromised patients (e.g. HIV patients, patients with a history of transplantation);
- •Insufficient understanding of the Dutch or English language;
- •Pregnant women;
- •Lactating women.
研究组 & 干预措施
Imiquimod
Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks.
干预措施: Imiquimod (Drug)
Imiquimod
Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks.
干预措施: paracetamol (Drug)
Imiquimod
Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks.
干预措施: lidocaine in Vaseline ointment (Drug)
结局指标
主要结局
Clinical response
时间窗: 12 weeks after the end of treatment
Clinical response will be assessed by vulvar examination and measurement and is defined as complete remission, partial remission (decrease by ≥50% of total lesion size) or no remission.
次要结局
- Tolerability questionnaire(4, 10 and 16 weeks after the start of treatment)
- Adverse events(4, 10 and 16 weeks after the start of treatment)
- Immunological response(Baseline, 4 and 28 weeks after start of treatment)
- Quality of life: general.(Baseline, 4 and 28 weeks after start of treatment.)
- Quality of life: sexuality.(Baseline, 4 and 28 weeks after start of treatment.)
- Quality of life: dermatology specific.(Baseline, 4 and 28 weeks after start of treatment.)
研究者
Joanne A. de Hullu, MD, PhD
MD PhD
University Medical Center Nijmegen