Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-29 @ 3:16 AM
Study NCT ID:
NCT03076892
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2017-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-12-10', 'releaseDate': '2019-11-25'}], 'estimatedResultsFirstSubmitDate': '2019-11-25'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Split Face intra individual comparison'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-13', 'studyFirstSubmitDate': '2017-03-07', 'studyFirstSubmitQcDate': '2017-03-09', 'lastUpdatePostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treated lesion response rate', 'timeFrame': 'up to Month 6', 'description': 'Each treatment area will be counted, graded with Clinical grade of AK, mapped and photographed'}], 'secondaryOutcomes': [{'measure': 'Visual analog scale of pain', 'timeFrame': 'at Day 1 and Day 7', 'description': 'measure the pain and local tolerance graduation range 0 to 10.'}, {'measure': "Scale for clinical assessment of the subject's skin aspect", 'timeFrame': 'at Month 3 and Month 6', 'description': '4-point scale that ranged of Excellent :No scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared to adjacent skin Good: No scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin Fair: Slight to moderate occurrence of scarring, atrophy or induration Poor : Extensive occurrence of scarring, atrophy or induration'}, {'measure': 'Rate of patients with at least 75% of reduction of the lesions', 'timeFrame': 'at Month 3 and Month 6', 'description': 'The response rate is calculated in relation to the initial number of lesions: Response rate is validated if rate ≥ 4 lesions destroyed for 5 initial lesions, ≥ 5 for 6 lesions and ≥ 6 for 7 lesions'}, {'measure': 'Dermatology Life Quality Index (DLQI )', 'timeFrame': 'at day 1 , Day 7, Month 3 and Month 6', 'description': 'The questionnaire of 10 questions is completed by the patient to evaluate his quality of life'}, {'measure': 'Satisfaction autoquestionnaire', 'timeFrame': 'at Day 7, Month 3 and Month 6', 'description': "The questionnaire is created by investigator to evaluate the comfort of device.\n\nParticipants will answer 9 questions on a 5-point scale that ranged from Not embarrassing,few embarrassing, Embarrassing, Very embarrassing, Don't know"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PDT', 'Methyl Aminolevulinate', 'light emitting textile'], 'conditions': ['Keratosis, Actinic']}, 'referencesModule': {'references': [{'pmid': '31025953', 'type': 'DERIVED', 'citation': 'Vignion-Dewalle AS, Abi Rached H, Thecua E, Lecomte F, Deleporte P, Behal H, Hommel T, Duhamel A, Szeimies RM, Mortier L, Mordon S. A New Light-Emitting, Fabric-Based Device for Photodynamic Therapy of Actinic Keratosis: Protocol for a Randomized, Controlled, Multicenter, Intra-Individual, Phase II Noninferiority Study (the Phosistos Study). JMIR Res Protoc. 2019 Apr 26;8(4):e12990. doi: 10.2196/12990.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the efficacy and tolerance of a new photodynamic therapy device (PHOS-ISTOS) with the conventional PDT device (Aktilite®) for the treatment of actinic keratosis of the scalp', 'detailedDescription': 'The study is an intraindividual comparison of two methods. The number of subjects to be enrolled is 47. Patients will receive both treatments in a single visit: A first period of 2.5 hours of illumination with Phos-Istos device followed by a continuous red light spectrum (between 7 and 10 minutes) with Aktilite® after an appropriate incubation of MAL (methyl aminolevulinate). Patients will complete a pain assessment scale after receiving both treatments. 3 follow-up visits will be then scheduled'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of minimum 10 previously untreated not pigmented, non-hyperkeratotic AK lesions of Grade I and II of the forehead and/or scalp (according to Olsen et Al. JAAD 1991, cf. REF 31) where other therapies are unacceptable or considered medically less appropriate with a symmetrical repartition on both side of the forehead and/or scalp. The diagnosis of AK will be determined upon clinical evaluation (i.e. visual inspection and palpation) by the investigator.\n* No treatment for the AKs in the previous 30 days.\n* Symmetrical areas in terms of number and severity of lesions. The axis of symmetry between the two areas will be defined by the investigator according to the distribution of lesions.\n* The two areas to be treated should not be coalescing. A minimum distance of 10 mm is required between the lesions located on the 2 symmetrical areas. A minimum distance of 2 mm is required between the lesions on the same side.\n* Minimum 5 lesions with similar dimensions at both symmetrical areas will be treated. If the number of lesions is \\>7, only 7 lesions on each side will be considered.\n\nExclusion Criteria:\n\n* Patients with porphyria.\n* Patients immunosuppressed for idiopathic, disease specific or therapeutic reasons.\n* Use of topical corticosteroids to lesional areas within 2 weeks before PDT.\n* Patients receiving local treatment (including cryotherapy and curettage-electrocoagulation, any PDT treatment) in face / scalp area within the last 30 days.\n* Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac, Picato) in face / scalp area within the last 30 days.in\n* Use of topical retinoids or alpha-hydroxy acids, systemic retinoids, chemotherapy or immunotherapy within 30 days of PDT.\n* Pigmented AK lesion(s).\n* Known allergy to Metvixia/Metvix, a similar PDT compound or excipients of the cream including arachis oil, or to peanut or soya.\n* Participation in other clinical studies either currently or within the last 30 days.\n* Female subjects must be of either:\n\n * Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,\n * Childbearing potential, provided there is a confirmed negative urine pregnancy test or blood analysis prior to study treatment, to rule out pregnancy.\n* Any condition which may be associated with a risk of poor protocol compliance.\n* Patients currently receiving regular ultraviolet radiation therapy.'}, 'identificationModule': {'nctId': 'NCT03076892', 'acronym': 'PHOS-ISTOS', 'briefTitle': 'Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'A Phase II Study Evaluating the Non-inferiority and Better Tolerability of the Device PHOS-ISTOS Compared to the Conventional Photodynamic Therapy (PDT)', 'orgStudyIdInfo': {'id': '2015_79'}, 'secondaryIdInfos': [{'id': '2016-A00010-51', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional PDT', 'description': 'Aktilite® Galderma', 'interventionNames': ['Device: Aktilite® Galderma']}, {'type': 'EXPERIMENTAL', 'label': 'PHOS ISTOS PDT', 'description': 'Light Emitting textile device', 'interventionNames': ['Device: PHOS ISTOS PDT']}], 'interventions': [{'name': 'Aktilite® Galderma', 'type': 'DEVICE', 'otherNames': ['Conventional PDT'], 'description': 'preparation of the lesions, Metvixia application + occlusive dressing during 3 hours + illumination: 7 to 10 minutes', 'armGroupLabels': ['Conventional PDT']}, {'name': 'PHOS ISTOS PDT', 'type': 'DEVICE', 'description': 'preparation of the lesions, Metvixia application + occlusive dressing during 30 minutes + illumination: 2.5 hours', 'armGroupLabels': ['PHOS ISTOS PDT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59045', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU, Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '45657', 'city': 'Recklinghausen', 'country': 'Germany', 'facility': 'Klinikum Vest Gmbh', 'geoPoint': {'lat': 51.61379, 'lon': 7.19738}}], 'overallOfficials': [{'name': 'Laurent Mortier, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Commission', 'class': 'OTHER'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-11-25', 'type': 'RELEASE'}, {'date': '2019-12-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University Hospital, Lille'}}}}