Clinical trial NCT03713203: PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paget Disease of the Vulva
Paget Disease, Extramammary
Keywords: Photodynamic Therapy (PDT)
Medical Device
Paget Disease
Metvixia®
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Galderma R&D
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2018-10-19
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: disease control rate in 30% of patients included
timeFrame: At 3 months
Secondary outcomes:
measure: disease control rate in 30% of patients included
timeFrame: at 6 months
measure: Subject discomfort measured during each treatment using a Visual Analogic Scale Evaluation of pain
timeFrame: 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)
measure: Clinical Evolution measured using an erythema 4 points scale and Chroma meter CR400 measures
timeFrame: at 3 months, at 6 months
measure: Presence/absence of Paget cells in vulvar biopsy.
timeFrame: at 3 months, at 6 months
measure: Change in score Dermatology Life Quality Index (DLQI)
timeFrame: at 3 months, at 6 months
measure: Change in SF 36
timeFrame: at 3 months, at 6 months
measure: Change in Hospital Anxiety and Depression Scale. (HADS)
timeFrame: at 3 months, at 6 months
measure: Change in The Female Sexual Function Index (FSFI)
timeFrame: at 3 months, at 6 months
measure: Presence or absence of fluorescence on the Dermoscope Fotofinder® photographs
timeFrame: at 6 months
measure: number of Adverse Events
timeFrame: during the study period, an average 6 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHU
Study officials:
affiliation: University Hospital, Lille
name: Laurent Mortier, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.