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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; 8(12):e15026JR

Abstract

BACKGROUND

Extramammary Paget disease of the vulva (EMPV) is a rare skin disorder commonly seen in postmenopausal Caucasian females that appears clinically as red, eczematous, pruriginous, and sometimes painful lesions. Although most cases are noninvasive, EMPV may be associated with an underlying or distant adenocarcinoma. EMPV has a chronic and relapsing course. The reference treatment is based on local surgical excision with negative margins. However, disease frequently extends far from the visible lesion, and surgical margins are frequently positive. Topical photodynamic therapy (PDT) is an established treatment modality for various dermatooncologic conditions. For example, red light irradiation with the Aktilite CL 128 and Metvixia (Galderma SA) as a photosensitizing molecule is a conventional protocol approved and widely used in Europe for PDT treatment of actinic keratosis, but this treatment is not yet widely used for EMPV because it has never clearly been demonstrated and is very painful.

OBJECTIVE

The aim of the study is to investigate the efficacy and safety relating to the medical device PAGETEX as a new painless PDT device using Metvixia in the treatment of vulvar Paget disease. The primary end point is the disease control rate at 3 months in 30% of the patients included, defined as stability, partial response, or total response, considering the extent of the lesion. Secondary end points are the disease control rate at 6 months, patient quality of life, level of pain experienced by the patient at each PDT session, severity of erythema, presence of protoporphyrin IX in Paget cells after each PDT session, and overall satisfaction level of the patient.

METHODS

The trial is an interventional, exploratory, simple group, nonrandomized, and single center (Lille University Hospital) study. Twenty-four patients will be included according to Simon's optimal plan. Therapeutic procedure is based on a cycle of two PDT sessions with the PAGETEX medical device at 15-day intervals (Metvixia incubation during 30 minutes and 635 nm red light illumination with a low irradiance for 2 hours and 30 minutes for a total fluence of 12 J/cm²). At the assessment session, 3 months after inclusion, if the control of the disease is partial or null, the patient will complete another cycle of two PDT sessions. A final evaluation will be performed in all patients at 6 months. Analyses will be performed using SAS version 9.4 software (SAS Institute Inc). The characteristics of the patients at baseline will be described; qualitative variables will be described by numbers and percentages, and quantitative variables will be described either by the mean and standard deviation for Gaussian distribution or by the median and interquartile range (ie, 25th and 75th percentiles). The normality of the distributions will be tested by a Shapiro-Wilk test and checked graphically by histograms.

RESULTS

First patient was included in September 2019 and clinical investigations are planned until August 2022. The final results of this study are expected to be available in January 2023.

CONCLUSIONS

This clinical trial aims to evaluate the efficacy and safety of a new PDT protocol for the treatment of EMPV. The PAGETEX device could become the treatment of choice if it is effective, painless, and easy to implement and use in hospitals.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03713203; https://clinicaltrials.gov/ct2/show/NCT03713203.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)

PRR1-10.2196/15026.

Authors+Show Affiliations

U1189 - Image Assisted Laser Therapies for Oncology, Inserm, Centre Hospitalier et Universitaire de Lille, Université de Lille, Lille, France.U1189 - Image Assisted Laser Therapies for Oncology, Inserm, Centre Hospitalier et Universitaire de Lille, Université de Lille, Lille, France.U1189 - Image Assisted Laser Therapies for Oncology, Inserm, Centre Hospitalier et Universitaire de Lille, Université de Lille, Lille, France.U1189 - Image Assisted Laser Therapies for Oncology, Inserm, Centre Hospitalier et Universitaire de Lille, Université de Lille, Lille, France.EA 2694 - Santé Publique: Epidémiologie et Qualité des Soins, Unité de Biostatistiques, Centre Hospitalier et Universitaire de Lille, Université de Lille, Lille, France.U1189 - Image Assisted Laser Therapies for Oncology, Inserm, Centre Hospitalier et Universitaire de Lille, Université de Lille, Lille, France. Department of Dermatology, Centre Hospitalier et Universitaire de Lille, Lille, France.Department of Dermatology, Centre Hospitalier et Universitaire de Lille, Lille, France.U1189 - Image Assisted Laser Therapies for Oncology, Inserm, Centre Hospitalier et Universitaire de Lille, Université de Lille, Lille, France.U1189 - Image Assisted Laser Therapies for Oncology, Inserm, Centre Hospitalier et Universitaire de Lille, Université de Lille, Lille, France. Department of Dermatology, Centre Hospitalier et Universitaire de Lille, Lille, France.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31793891

Citation

Lecomte, Fabienne, et al. "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 Research Protocols, vol. 8, no. 12, 2019, pp. e15026.
Lecomte F, Thecua E, Ziane L, et al. 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;8(12):e15026.
Lecomte, F., Thecua, E., Ziane, L., Deleporte, P., Duhamel, A., Maire, C., ... Mortier, L. (2019). 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 Research Protocols, 8(12), pp. e15026. doi:10.2196/15026.
Lecomte F, et al. 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. PubMed PMID: 31793891.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Lecomte,Fabienne, AU - Thecua,Elise, AU - Ziane,Laurine, AU - Deleporte,Pascal, AU - Duhamel,Alain, AU - Maire,Cyril, AU - Staumont-Salle,Delphine, AU - Mordon,Serge, AU - Mortier,Laurent, Y1 - 2019/12/03/ PY - 2019/07/15/received PY - 2019/09/04/accepted PY - 2019/12/4/entrez PY - 2019/12/4/pubmed PY - 2019/12/4/medline KW - extramammary Paget disease of the vulva KW - light emitting fabrics KW - methyl aminolevulinate KW - photodynamic therapy SP - e15026 EP - e15026 JF - JMIR research protocols JO - JMIR Res Protoc VL - 8 IS - 12 N2 - BACKGROUND: Extramammary Paget disease of the vulva (EMPV) is a rare skin disorder commonly seen in postmenopausal Caucasian females that appears clinically as red, eczematous, pruriginous, and sometimes painful lesions. Although most cases are noninvasive, EMPV may be associated with an underlying or distant adenocarcinoma. EMPV has a chronic and relapsing course. The reference treatment is based on local surgical excision with negative margins. However, disease frequently extends far from the visible lesion, and surgical margins are frequently positive. Topical photodynamic therapy (PDT) is an established treatment modality for various dermatooncologic conditions. For example, red light irradiation with the Aktilite CL 128 and Metvixia (Galderma SA) as a photosensitizing molecule is a conventional protocol approved and widely used in Europe for PDT treatment of actinic keratosis, but this treatment is not yet widely used for EMPV because it has never clearly been demonstrated and is very painful. OBJECTIVE: The aim of the study is to investigate the efficacy and safety relating to the medical device PAGETEX as a new painless PDT device using Metvixia in the treatment of vulvar Paget disease. The primary end point is the disease control rate at 3 months in 30% of the patients included, defined as stability, partial response, or total response, considering the extent of the lesion. Secondary end points are the disease control rate at 6 months, patient quality of life, level of pain experienced by the patient at each PDT session, severity of erythema, presence of protoporphyrin IX in Paget cells after each PDT session, and overall satisfaction level of the patient. METHODS: The trial is an interventional, exploratory, simple group, nonrandomized, and single center (Lille University Hospital) study. Twenty-four patients will be included according to Simon's optimal plan. Therapeutic procedure is based on a cycle of two PDT sessions with the PAGETEX medical device at 15-day intervals (Metvixia incubation during 30 minutes and 635 nm red light illumination with a low irradiance for 2 hours and 30 minutes for a total fluence of 12 J/cm²). At the assessment session, 3 months after inclusion, if the control of the disease is partial or null, the patient will complete another cycle of two PDT sessions. A final evaluation will be performed in all patients at 6 months. Analyses will be performed using SAS version 9.4 software (SAS Institute Inc). The characteristics of the patients at baseline will be described; qualitative variables will be described by numbers and percentages, and quantitative variables will be described either by the mean and standard deviation for Gaussian distribution or by the median and interquartile range (ie, 25th and 75th percentiles). The normality of the distributions will be tested by a Shapiro-Wilk test and checked graphically by histograms. RESULTS: First patient was included in September 2019 and clinical investigations are planned until August 2022. The final results of this study are expected to be available in January 2023. CONCLUSIONS: This clinical trial aims to evaluate the efficacy and safety of a new PDT protocol for the treatment of EMPV. The PAGETEX device could become the treatment of choice if it is effective, painless, and easy to implement and use in hospitals. TRIAL REGISTRATION: ClinicalTrials.gov NCT03713203; https://clinicaltrials.gov/ct2/show/NCT03713203. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/15026. SN - 1929-0748 UR - https://www.unboundmedicine.com/medline/citation/31793891/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 L2 - https://www.researchprotocols.org/2019/12/e15026/ DB - PRIME DP - Unbound Medicine ER -