Меню
Идёт набор NCT03713203

PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).

Без фазы С лечением Paget Disease of the Vulva Paget Disease, Extramammary

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: pagetex PDT.
Кому может быть актуально
Состояния в реестре: Paget Disease of the Vulva, Paget Disease, Extramammary. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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)

Обзор

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.

Вмешательства

  • Устройство pagetex PDT
    2 to 4 sessions of PDT treatment during 2.5 hours after application of Metvixia and incubation under occlusive coat.

Первичные конечные точки

  • disease control rate in 30% of patients included [Срок оценки: At 3 months]
Вторичные конечные точки (10)
  • disease control rate in 30% of patients included [Срок оценки: at 6 months]
  • Subject discomfort measured during each treatment using a Visual Analogic Scale Evaluation of pain [Срок оценки: 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 [Срок оценки: at 3 months, at 6 months]
  • Presence/absence of Paget cells in vulvar biopsy. [Срок оценки: at 3 months, at 6 months]
  • Change in score Dermatology Life Quality Index (DLQI) [Срок оценки: at 3 months, at 6 months]
  • Change in SF 36 [Срок оценки: at 3 months, at 6 months]
  • Change in Hospital Anxiety and Depression Scale. (HADS) [Срок оценки: at 3 months, at 6 months]
  • Change in The Female Sexual Function Index (FSFI) [Срок оценки: at 3 months, at 6 months]
  • Presence or absence of fluorescence on the Dermoscope Fotofinder® photographs [Срок оценки: at 6 months]
  • number of Adverse Events [Срок оценки: during the study period, an average 6 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Франция · 1 центр
  • Hôpital Claude Huriez, CHU — Lille

Публикации

  • Lecomte F, Thecua E, Ziane L, Deleporte P, Duhamel A, Maire C, Staumont-Salle D, Mordon S, Mortier L. Photodynamic Therapy Using a New Painless Light-Emitting Fabrics Device in the Treatment of Extramammary Paget Disease of the Vulva (the PAGETEX Study): Protocol for an Interventional Efficacy and Safety Trial. JMIR Res Protoc. 2019 Dec 3;8(12):e15026. doi: 10.2196/15026. PMID 31793891

Идентификаторы

NCT: NCT03713203 · 2017_71 · 2018-A01873-52 · 2018-002604-13

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗