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

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ClinicalTrials.gov Identifier: NCT03713203
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : November 19, 2020
Sponsor:
Collaborators:
Galderma R&D
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date  ICMJE October 15, 2018
First Posted Date  ICMJE October 19, 2018
Last Update Posted Date November 19, 2020
Actual Study Start Date  ICMJE August 27, 2019
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
disease control rate in 30% of patients included [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
disease control rate in 30% of patients included [ Time Frame: 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), no remission or progression of the disease
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
  • disease control rate in 30% of patients included [ Time Frame: at 6 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
  • 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) ]
    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 [ Time Frame: at 3 months, at 6 months ]
    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. [ Time Frame: at 3 months, at 6 months ]
  • Change in score Dermatology Life Quality Index (DLQI) [ Time Frame: at 3 months, at 6 months ]
    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 [ Time Frame: at 3 months, at 6 months ]
  • Change in Hospital Anxiety and Depression Scale. (HADS) [ Time Frame: at 3 months, at 6 months ]
    Each item on the questionnaire is scored from 0-3
  • Change in The Female Sexual Function Index (FSFI) [ Time Frame: at 3 months, at 6 months ]
    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 [ Time Frame: at 6 months ]
  • number of Adverse Events [ Time Frame: during the study period, an average 6 months ]
    Incidence and severity of adverse device effects during the study period
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • disease control rate in 30% of patients included [ Time Frame: at 6 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), no remission or progression of the disease
  • 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) ]
    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 [ Time Frame: at 3 months, at 6 months ]
    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. [ Time Frame: at 3 months, at 6 months ]
  • Change in score Dermatology Life Quality Index (DLQI) [ Time Frame: at 3 months, at 6 months ]
    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 [ Time Frame: at 3 months, at 6 months ]
  • Change in Hospital Anxiety and Depression Scale. (HADS) [ Time Frame: at 3 months, at 6 months ]
    Each item on the questionnaire is scored from 0-3
  • Change in The Female Sexual Function Index (FSFI) [ Time Frame: at 3 months, at 6 months ]
    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 [ Time Frame: at 6 months ]
  • number of Adverse Events [ Time Frame: during the study period, an average 6 months ]
    Incidence and severity of adverse device effects during the study period
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).
Official Title  ICMJE 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)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Paget Disease of the Vulva
  • Paget Disease, Extramammary
Intervention  ICMJE Device: pagetex PDT
2 to 4 sessions of PDT treatment during 2.5 hours after application of Metvixia and incubation under occlusive coat.
Study Arms  ICMJE Experimental: 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®)"
Intervention: Device: pagetex PDT
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Patients diagnosed with Paget's Disease Extra-Mammary Vulvae confirmed by biopsy of less than one year.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laurent Mortier, MD,PhD (0)3 20 44 48 68 ext +33 laurent.mortier@chru-lille.fr
Contact: Serge Mordon, MD,PhD serge.mordon@inserm.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03713203
Other Study ID Numbers  ICMJE 2017_71
2018-A01873-52 ( Other Identifier: ID-RCB number, ANSM )
2018-002604-13 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE
  • Galderma R&D
  • Institut National de la Santé Et de la Recherche Médicale, France
Investigators  ICMJE
Principal Investigator: Laurent Mortier, MD,PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP