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Recruiting NCT03713203

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

No phase Interventional Paget Disease of the Vulva Paget Disease, Extramammary

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pagetex PDT.
Who it may be relevant to
Registry conditions: Paget Disease of the Vulva, Paget Disease, Extramammary. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Hôpital Claude Huriez, CHU — Lille

Publications

  • 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

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗