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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 : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborators:
Galderma
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Lille

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.


Condition or disease Intervention/treatment Phase
Paget Disease of the Vulva Paget Disease, Extramammary Device: pagetex PDT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
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®)"
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 :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. Presence/absence of Paget cells in vulvar biopsy. [ Time Frame: at 3 months, at 6 months ]
  5. 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

  6. Change in SF 36 [ Time Frame: at 3 months, at 6 months ]
  7. 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

  8. 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

  9. Presence or absence of fluorescence on the Dermoscope Fotofinder® photographs [ Time Frame: at 6 months ]
  10. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713203


Contacts
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

Sponsors and Collaborators
University Hospital, Lille
Galderma
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Laurent Mortier, MD,PhD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03713203     History of Changes
Other Study ID Numbers: 2017_71
2018-A01873-52 ( Other Identifier: ID-RCB number, ANSM )
2018-002604-13 ( EudraCT Number )
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Photodynamic Therapy (PDT)
Medical Device
Paget Disease
Metvixia®

Additional relevant MeSH terms:
Paget Disease, Extramammary
Paget's Disease, Mammary
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating