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

Primary Purpose

Paget Disease of the Vulva, Paget Disease, Extramammary

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
pagetex PDT
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paget Disease of the Vulva focused on measuring Photodynamic Therapy (PDT), Medical Device, Paget Disease, Metvixia®

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Claude Huriez, CHURecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pagetex PDT

Arm Description

PAGETEX medical device for photodynamic therapy (PDT). Composed of the association: "Laser source + optical fiber + diffuser support incorporating luminous textiles + drug photosensitizer (Metvixia®)"

Outcomes

Primary Outcome Measures

disease control rate in 30% of patients included
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

Secondary Outcome Measures

disease control rate in 30% of patients included
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
Subject discomfort measured during each treatment using a Visual Analogic Scale Evaluation of pain
Visual Analogic Scale Evaluation of pain (0 = no pain to 10= unbearable)
Clinical Evolution measured using an erythema 4 points scale and Chroma meter CR400 measures
erythema 4 points scale (0 = no erythema, 3=severe erythema) and Chroma meter CR400 (Konica Minolta) measures
Presence/absence of Paget cells in vulvar biopsy.
Change in score Dermatology Life Quality Index (DLQI)
DLQI is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person The scoring of each question is as follows:Very much/A lot/A little/Not at all/Not relevan
Change in SF 36
Change in Hospital Anxiety and Depression Scale. (HADS)
Each item on the questionnaire is scored from 0-3
Change in The Female Sexual Function Index (FSFI)
The FSFI is a brief questionnaire measure of sexual functioning in women. 19 questions scoring as follow : 0 = Did not attempt intercourse ;1 = Almost always or always 2 = Most times (more than half the time);3 = Sometimes (about half the time);4 = A few times (less than half the time); 5 = Almost never or never
Presence or absence of fluorescence on the Dermoscope Fotofinder® photographs
number of Adverse Events
Incidence and severity of adverse device effects during the study period

Full Information

First Posted
October 15, 2018
Last Updated
June 3, 2022
Sponsor
University Hospital, Lille
Collaborators
Galderma R&D, Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT03713203
Brief Title
PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).
Acronym
PAGETEX
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2019 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Galderma R&D, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paget Disease of the Vulva, Paget Disease, Extramammary
Keywords
Photodynamic Therapy (PDT), Medical Device, Paget Disease, Metvixia®

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pagetex PDT
Arm Type
Experimental
Arm Description
PAGETEX medical device for photodynamic therapy (PDT). Composed of the association: "Laser source + optical fiber + diffuser support incorporating luminous textiles + drug photosensitizer (Metvixia®)"
Intervention Type
Device
Intervention Name(s)
pagetex PDT
Intervention Description
2 to 4 sessions of PDT treatment during 2.5 hours after application of Metvixia and incubation under occlusive coat.
Primary Outcome Measure Information:
Title
disease control rate in 30% of patients included
Description
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
Time Frame
At 3 months
Secondary Outcome Measure Information:
Title
disease control rate in 30% of patients included
Description
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
Time Frame
at 6 months
Title
Subject discomfort measured during each treatment using a Visual Analogic Scale Evaluation of pain
Description
Visual Analogic Scale Evaluation of pain (0 = no pain to 10= unbearable)
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)
Title
Clinical Evolution measured using an erythema 4 points scale and Chroma meter CR400 measures
Description
erythema 4 points scale (0 = no erythema, 3=severe erythema) and Chroma meter CR400 (Konica Minolta) measures
Time Frame
at 3 months, at 6 months
Title
Presence/absence of Paget cells in vulvar biopsy.
Time Frame
at 3 months, at 6 months
Title
Change in score Dermatology Life Quality Index (DLQI)
Description
DLQI is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person The scoring of each question is as follows:Very much/A lot/A little/Not at all/Not relevan
Time Frame
at 3 months, at 6 months
Title
Change in SF 36
Time Frame
at 3 months, at 6 months
Title
Change in Hospital Anxiety and Depression Scale. (HADS)
Description
Each item on the questionnaire is scored from 0-3
Time Frame
at 3 months, at 6 months
Title
Change in The Female Sexual Function Index (FSFI)
Description
The FSFI is a brief questionnaire measure of sexual functioning in women. 19 questions scoring as follow : 0 = Did not attempt intercourse ;1 = Almost always or always 2 = Most times (more than half the time);3 = Sometimes (about half the time);4 = A few times (less than half the time); 5 = Almost never or never
Time Frame
at 3 months, at 6 months
Title
Presence or absence of fluorescence on the Dermoscope Fotofinder® photographs
Time Frame
at 6 months
Title
number of Adverse Events
Description
Incidence and severity of adverse device effects during the study period
Time Frame
during the study period, an average 6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients diagnosed with Paget's Disease Extra-Mammary Vulvae confirmed by biopsy of less than one year.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent Mortier, MD,PhD
Phone
(0)3 20 44 48 68
Ext
+33
Email
laurent.mortier@chru-lille.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Serge Mordon, MD,PhD
Email
serge.mordon@inserm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Mortier, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Claude Huriez, CHU
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Mortier, MD,PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31793891
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.
Results Reference
derived

Learn more about this trial

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

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