An Interventional, Phase II, Non Randomized, Mono-centric Study on the Clinical Efficacy and Safety of the Medical Device PAGETEX® as a Photodynamic Therapy Device in the Treatment of Extra-Mammary Paget's Disease of the Vulva (EMPV)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- disease control rate in 30% of patients included
研究概览
简要总结
Vulvar Paget's disease is a rare skin tumour which affect Caucasian post-menopausal women. The disease is revealed by erythematous, eczematous, pruritus and vulvar burns. The diagnosis is often late (from a few months to several years) because the symptoms are neglected by patients or misinterpreted by doctors. The reference treatment is based on surgical excision but unfortunately local recurrences are very frequent (17 to 38% of cases).
Photodynamic therapy (PDT) is already used in some dermatological pathologies and could therefore be an alternative treatment.
The objective of this study is to assess the efficacy and evaluate the safety of the new PDT device "PAGETEX" for the treatment of vulvar Paget's disease.
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
- 否
入选标准
- •Non-invasive, primary or recurrent vulvar Paget's disease after surgical resection
- •Ability to give informed consent.
- •Ability to adhere to the study protocol
- •Patients must have biopsy (< 1year) proven recurrent extra mammary Paget's disease
- •Effective contraception for Women of childbearing potential
排除标准
- •Invasive vulvar Paget's Disease
- •Underlying adenocarcinoma
- •Subject to photosensitive disorders / reactions
- •Treatment with Imiquimod / Aldara 5% cream in the last 3 months
- •Photodynamic therapy used to treat MPV lesions in the last 3 months
- •Use of photosensitive agents in the last 3 months
- •Treatment with an experimental drug in the 30 days prior to the start of the study,
- •Allergic or hypersensitivity to methyl aminolevulinate or any of the other ingredients of this medication (propyl p-hydroxybenzoate, cetostearyl alcohol, methyl p-hydroxybenzoate)
- •Allergic or hypersensitivity to peanut or soya due to the presence of peanut oil in Metvixia®
- •Patient with Porphyria
- •Patient already treated with topical corticosteroids on the injured area in the last 3 months
- •Patients with immunity disorders (HIV, transplantation)
- •Clinical follow-up impossible for psychological, family, social or geographical reasons,
- •Legal incapacity
- •Pregnant or lactating woman
- •Refuse to participate in or sign the consent of the study
研究组 & 干预措施
Pagetex PDT
PAGETEX medical device for photodynamic therapy (PDT). Composed of the association: "Laser source + optical fiber + diffuser support incorporating luminous textiles + drug photosensitizer (Metvixia®)"
干预措施: pagetex PDT (Device)
结局指标
主要结局
disease control rate in 30% of patients included
时间窗: At 3 months
Clinical response will be assessed by vulvar examination by the investigator and independent medical committee. Measurement is defined as complete remission, partial remission (decrease by \>50% of total lesion size), stability ( decrease by \<50% of total lesion size )or progression of the disease
次要结局
- Presence/absence of Paget cells in vulvar biopsy.(at 3 months, at 6 months)
- Change in SF 36(at 3 months, at 6 months)
- number of Adverse Events(during the study period, an average 6 months)
- Presence or absence of fluorescence on the Dermoscope Fotofinder® photographs(at 6 months)
- Subject discomfort measured during each treatment using a Visual Analogic Scale Evaluation of pain(At session 1 and session 2, spaced 15 day; and at session 3 and session 4 spaced 15 days (sessions 3 ; 4 in case of persistent lesions))
- Clinical Evolution measured using an erythema 4 points scale and Chroma meter CR400 measures(at 3 months, at 6 months)
- Change in The Female Sexual Function Index (FSFI)(at 3 months, at 6 months)
- disease control rate in 30% of patients included(at 6 months)
- Change in Hospital Anxiety and Depression Scale. (HADS)(at 3 months, at 6 months)
- Change in score Dermatology Life Quality Index (DLQI)(at 3 months, at 6 months)