Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-01-27 @ 1:33 AM
Study NCT ID:
NCT02139618
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2014-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C475457', 'term': 'methyl 5-aminolevulinate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2014-04-29', 'studyFirstSubmitQcDate': '2014-05-13', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global photodamage improvement', 'timeFrame': '1 month after third session', 'description': 'The primary outcome is global photodamage improvement 1 month after the third daylight PDT session, according to Dover´s photodamage scale.'}], 'secondaryOutcomes': [{'measure': 'Pain measurement', 'timeFrame': 'After 2 hours of sun exposure in each session', 'description': 'Pain evaluation with the visual analogue scale after 2 hours of sun exposure in each of the sessions performed (Sessions 1, 2 and 3).'}, {'measure': 'Specific Photodamage score', 'timeFrame': '1 month after the third session', 'description': 'Specific photodamage severity score for fine lines, coarse lines, tactile roughness, mottled pigmentation, sallowness, and erythema one month after the third daylight PDT session, according to Dover´s photodamage scale.'}, {'measure': 'Sun irradiance and illuminance quantification', 'timeFrame': 'During the 2 hours of each session', 'description': 'Sun irradiation and illuminance quantification during exposure'}, {'measure': 'Adverse events', 'timeFrame': 'From recruitment until 1 month after the third session', 'description': 'Any adverse event'}, {'measure': 'Therapy tolerance', 'timeFrame': '1 week after sessions 1,2 and 3', 'description': 'Therapy tolerance will be recorded with a scale that includes a 4-grade severity score for oozing, erythema, oedema, desquamation, pigmentation, and vesiculation.'}, {'measure': 'Quality of life assessment (Skindex-29 Instrument)', 'timeFrame': 'Basal and 1 month after the third session', 'description': 'Quality of life assessment (Skindex-29 Instrument)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Randomized-controlled-trial', 'Methyl-Aminolevulinate', 'Daylight', 'Photodynamic-therapy'], 'conditions': ['Facial Photodamage']}, 'descriptionModule': {'briefSummary': 'Treatment of actinic damage has included multiple procedures but to date there is limited scientific evidence to support the preferential use of one of these therapies according to their efficacy, safety and pain tolerance by patients. This study aims to assess the efficacy of methyl aminolevulinate + daylight vs placebo + daylight to treat facial photodamage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with symmetric facial photodamage grade 2 or 3 (Dover´s scale)\n* Patients willing to participate\n* Signed informed consent\n\nExclusion Criteria:\n\n* Pregnant or nursing females\n* Subjects with any photosensitizing disorder\n* Any active infectious skin disorder\n* History of herpes simplex in the face\n* Subjects with less than 6 months of any previous rejuvenation interfering treatments\n* History of systemic isotretinoin in the last year\n* Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments\n* History of hypersensitivity reactions\n* Activities with high sun exposure during 48 hours after treatment\n* Clinical suspicion of any systemic or local malignancy'}, 'identificationModule': {'nctId': 'NCT02139618', 'briefTitle': 'Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Dermabase'}, 'officialTitle': 'A Double-blind Randomized-controlled Trial to Assess the Efficacy of Methyl Aminolevulinate + Daylight vs Placebo + Daylight in Patients With Facial Photodamage', 'orgStudyIdInfo': {'id': '2013-01INT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methyl Aminolevulinate (MAL)', 'description': '1 gram of Topical Methyl Aminolevulinate (MAL) applied to the whole face 30 minutes before sun exposure for 2 hours (3 sessions , 2 to 4 weeks apart)', 'interventionNames': ['Drug: Methyl Aminolevulinate (MAL)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 gram of placebo cream applied to the whole face 30 minutes before sun exposure for 2 hours (3 sessions , 2 to 4 weeks apart)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Methyl Aminolevulinate (MAL)', 'type': 'DRUG', 'otherNames': ['Metvix®'], 'armGroupLabels': ['Methyl Aminolevulinate (MAL)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01', 'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'IPS Universitaria', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}], 'overallOfficials': [{'name': 'Gloria Sanclemente, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Antioquia. Medellin, Colombia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Dermabase', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grupo de Investigacion Dermatologica (GRID)', 'class': 'UNKNOWN'}, {'name': 'IPS Universitaria-Universidad de Antioquia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}