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 : May 29, 2019
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)|
|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 :||July 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
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.
- 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
- 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
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
|Contact: Laurent Mortier, MD,PhD||(0)3 20 44 48 68 ext +firstname.lastname@example.org|
|Contact: Serge Mordon, MD,PhDemail@example.com|
|Principal Investigator:||Laurent Mortier, MD,PhD||University Hospital, Lille|