Ignite Creation Date:
2025-12-25 @ 4:40 AM
Ignite Modification Date:
2026-02-09 @ 2:42 AM
Study NCT ID:
NCT03076918
Status:
TERMINATED
Last Update Posted:
2018-05-18
First Post:
2017-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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 intraindividual comparison'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'whyStopped': 'decision of the investigator in the face of new scientific knowledge', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-15', 'studyFirstSubmitDate': '2017-03-07', 'studyFirstSubmitQcDate': '2017-03-09', 'lastUpdatePostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', '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': 'Day 1 and D ay 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': 'Months 3 and Months 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': 'Fluorescence measure of the PpIX', 'timeFrame': 'Baseline, after 3 hours of incubation, in case of treatment interruption, immediately after the treatment, and at 15 and 30 minutes after the end of the treatment.', 'description': 'Measures with Fluoderm photometer'}, {'measure': 'Irradiance measure in mW/cm2 for each AK', 'timeFrame': 'during Aktilite® treatment at Day 1', 'description': 'Measures realised with a wattmeter OPHIR LaserSTAR to know the power of light delivered'}, {'measure': 'Rate of patients with at least 75% of reduction of the lesions', 'timeFrame': 'Months 3 and Months 6', 'description': 'The reduction in the number of lesions will be calculated as a function of the initial number:≥4 destroyed if 5 lésions; ≥ 5 destroyed if 6 lésions and ≥6 destroyed if 7 lesions\n\n≥4 destroyed if 5 lesions'}, {'measure': 'Dermatology Life Quality Index (DLQI)', 'timeFrame': 'At Day 7, Months 3 and Months 6', 'description': 'The questionnaire of 10 questions is completed by the patient to evaluate his quality of life'}, {'measure': 'Satisfaction Questionnaire', 'timeFrame': 'At Day 7, Months 3 and Months 6', 'description': "The questionnaire es created by the investigator to evaluate the comfort of the device. Patient will give his overall satisfaction and the will answer 7 questions on a 5-point scale that ranged from Not embarrassing, few embarrassing, embarrassing, Very embarrassing, I Don't know"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PDT, Methyl Aminolevulinate, Light Emitting Textile'], 'conditions': ['Keratosis, Actinic']}, 'referencesModule': {'references': [{'pmid': '31025952', 'type': 'DERIVED', 'citation': 'Lecomte F, Vignion-Dewalle AS, Vicentini C, Thecua E, Deleporte P, Duhamel A, Mordon S, Mortier L. Evaluating the Noninferiority of a New Photodynamic Therapy (Flexitheralight) Compared With Conventional Treatment for Actinic Keratosis: Protocol for a Phase 2 Study. JMIR Res Protoc. 2019 Apr 26;8(4):e11530. doi: 10.2196/11530.'}]}, 'descriptionModule': {'briefSummary': 'This study compares the efficacy and tolerance of a new device (FLEXITHERALIGHT) for photodynamic therapy in the treatment of keratosis actinic in comparison of classical PDT with Aktilite®.', 'detailedDescription': 'The study is an intraindividual comparison of two methods. The number of subjects to be enrolled is 47 patients. All participants will receive both two treatments in a single visit : a first period of 2.5 hours of illumination with FLEXITHERALIGHT device followed by a continuous red light Spectrum (between 7 and 10 minutes) with Aktilite® after an appropriate incubation of methyl aminolevulinate).\n\nPatients will complete a pain assessment scale after receiving both treatments, then, 3 follow up visits will be 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* 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 10mm 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, any - Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac, Picato) in face / scalp area within the last 3 months.\n* Use of topical retinoids or alpha-hydroxy acids, urea or systemic retinoids, chemotherapy or immunotherapy within 4 weeks of PDT.\n* Pigmented AK lesion(s).\n* Known allergy to Metvixia, 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\nNon-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or, Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to study treatment, to rule out pregnancy.\n\n* Any condition which may be associated with a risk of poor protocol compliance.\n* Patients currently receiving regular ultraviolet radiation therapy'}, 'identificationModule': {'nctId': 'NCT03076918', 'acronym': 'Flexithera', 'briefTitle': 'Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'A Phase II Study Evaluating the Non-inferiority of the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy (PDT)', 'orgStudyIdInfo': {'id': '2013_23'}, 'secondaryIdInfos': [{'id': '2013-A01096-39', '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': 'FLEXITHERALIGHT PDT', 'description': 'Light Emitting Textile Device', 'interventionNames': ['Device: FLEXITHERALIGHT PDT']}], 'interventions': [{'name': 'FLEXITHERALIGHT PDT', 'type': 'DEVICE', 'description': 'Preparation of lesions, MAL application+occlusive dressing during 30 minutes+illumination 2.5 hours', 'armGroupLabels': ['FLEXITHERALIGHT PDT']}, {'name': 'Aktilite® Galderma', 'type': 'DEVICE', 'otherNames': ['Conventional PDT'], 'description': 'Preparation of lesions, MAL application+occlusive dressing during 3 hours+illumination 7 to 10 minutes', 'armGroupLabels': ['Conventional PDT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'CHRU, Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], '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': 'National Research Agency, France', 'class': 'OTHER'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}