Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-30 @ 6:35 AM
Study NCT ID:
NCT03713203
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2018-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010145', 'term': 'Paget Disease, Extramammary'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-08-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2018-10-15', 'studyFirstSubmitQcDate': '2018-10-18', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease control rate in 30% of patients included', 'timeFrame': 'At 3 months', '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'}], 'secondaryOutcomes': [{'measure': 'disease control rate in 30% of patients included', 'timeFrame': 'at 6 months', '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'}, {'measure': 'Subject discomfort measured during each treatment using a Visual Analogic Scale Evaluation of pain', 'timeFrame': '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)', 'description': 'Visual Analogic Scale Evaluation of pain (0 = no pain to 10= unbearable)'}, {'measure': 'Clinical Evolution measured using an erythema 4 points scale and Chroma meter CR400 measures', 'timeFrame': 'at 3 months, at 6 months', 'description': 'erythema 4 points scale (0 = no erythema, 3=severe erythema) and Chroma meter CR400 (Konica Minolta) measures'}, {'measure': 'Presence/absence of Paget cells in vulvar biopsy.', 'timeFrame': 'at 3 months, at 6 months'}, {'measure': 'Change in score Dermatology Life Quality Index (DLQI)', 'timeFrame': 'at 3 months, at 6 months', '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'}, {'measure': 'Change in SF 36', 'timeFrame': 'at 3 months, at 6 months'}, {'measure': 'Change in Hospital Anxiety and Depression Scale. (HADS)', 'timeFrame': 'at 3 months, at 6 months', 'description': 'Each item on the questionnaire is scored from 0-3'}, {'measure': 'Change in The Female Sexual Function Index (FSFI)', 'timeFrame': 'at 3 months, at 6 months', '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'}, {'measure': 'Presence or absence of fluorescence on the Dermoscope Fotofinder® photographs', 'timeFrame': 'at 6 months'}, {'measure': 'number of Adverse Events', 'timeFrame': 'during the study period, an average 6 months', 'description': 'Incidence and severity of adverse device effects during the study period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Photodynamic Therapy (PDT)', 'Medical Device', 'Paget Disease', 'Metvixia®'], 'conditions': ['Paget Disease of the Vulva', 'Paget Disease, Extramammary']}, 'referencesModule': {'references': [{'pmid': '31793891', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nPhotodynamic therapy (PDT) is already used in some dermatological pathologies and could therefore be an alternative treatment.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': "Patients diagnosed with Paget's Disease Extra-Mammary Vulvae confirmed by biopsy of less than one year.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Non-invasive, primary or recurrent vulvar Paget's disease after surgical resection\n* Ability to give informed consent.\n* Ability to adhere to the study protocol\n* Patients must have biopsy (\\< 1year) proven recurrent extra mammary Paget's disease\n* Effective contraception for Women of childbearing potential\n\nExclusion Criteria:\n\n* Invasive vulvar Paget's Disease\n* Underlying adenocarcinoma\n* Subject to photosensitive disorders / reactions\n* Treatment with Imiquimod / Aldara 5% cream in the last 3 months\n* Photodynamic therapy used to treat MPV lesions in the last 3 months\n* Use of photosensitive agents in the last 3 months\n* Treatment with an experimental drug in the 30 days prior to the start of the study,\n* Allergic or hypersensitivity to methyl aminolevulinate or any of the other ingredients of this medication (propyl p-hydroxybenzoate, cetostearyl alcohol, methyl p-hydroxybenzoate)\n* Allergic or hypersensitivity to peanut or soya due to the presence of peanut oil in Metvixia®\n* Patient with Porphyria\n* Patient already treated with topical corticosteroids on the injured area in the last 3 months\n* Patients with immunity disorders (HIV, transplantation)\n* Clinical follow-up impossible for psychological, family, social or geographical reasons,\n* Legal incapacity\n* Pregnant or lactating woman\n* Refuse to participate in or sign the consent of the study"}, 'identificationModule': {'nctId': 'NCT03713203', 'acronym': 'PAGETEX', 'briefTitle': "PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': "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)", 'orgStudyIdInfo': {'id': '2017_71'}, 'secondaryIdInfos': [{'id': '2018-A01873-52', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}, {'id': '2018-002604-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pagetex PDT', 'description': 'PAGETEX medical device for photodynamic therapy (PDT). Composed of the association: "Laser source + optical fiber + diffuser support incorporating luminous textiles + drug photosensitizer (Metvixia®)"', 'interventionNames': ['Device: pagetex PDT']}], 'interventions': [{'name': 'pagetex PDT', 'type': 'DEVICE', 'description': '2 to 4 sessions of PDT treatment during 2.5 hours after application of Metvixia and incubation under occlusive coat.', 'armGroupLabels': ['Pagetex PDT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent Mortier, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Claude Huriez, CHU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Laurent Mortier, MD,PhD', 'role': 'CONTACT', 'email': 'laurent.mortier@chru-lille.fr', 'phone': '(0)3 20 44 48 68', 'phoneExt': '+33'}, {'name': 'Serge Mordon, MD,PhD', 'role': 'CONTACT', 'email': 'serge.mordon@inserm.fr'}], 'overallOfficials': [{'name': 'Laurent Mortier, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Galderma R&D', 'class': 'INDUSTRY'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}