Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-01-08 @ 8:30 PM
Study NCT ID:
NCT03878433
Status:
COMPLETED
Last Update Posted:
2021-09-14
First Post:
2019-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008548', 'term': 'Melanosis'}], 'ancestors': [{'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2019-01-25', 'studyFirstSubmitQcDate': '2019-03-15', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of melasma', 'timeFrame': 'At baseline and at 12 weeks', 'description': 'Change from Baseline of the Modified Melasma Area and Severity Index (mMASI) total score at 12 months. The MASI is 0 à 24 : Front 0.3(D)(A)+ right malar 0.30(D)(A)+ left malar 0.30(D)(A)+ chin 0.1(D)(A)'}], 'secondaryOutcomes': [{'measure': 'Quality of life of patient: VAS (Visual Analog Scale)', 'timeFrame': 'At baseline and at 12 weeks', 'description': 'Change from Baseline of quality of life at 12 months (Visual Analog Scale with a graduation from 0 to 10)'}, {'measure': 'Satisfaction of the patients: VAS (Visual Analog Scale)', 'timeFrame': 'At baseline and at 12 weeks', 'description': 'Change from Baseline of satisfaction of the patients total score at 12 months (Visual Analog Scale with a graduation from 0 to 10)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melasma']}, 'descriptionModule': {'briefSummary': 'Oxidative stress has been reported to play a role in melasma pathophysiology. The objective of the study is to compare oral superoxide dismutase (GLISODin) to placebo, in combination to sunscreen to decrease melasma severity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically diagnosed melasma in adult patient\n* signed inform consent\n\nExclusion Criteria:\n\n* Pregnant women\n* Other pigmentary disorder of the afce\n* Use of depigmentant agent in the month before the inclusion\n* Use of topical steroid, tretinoin, hydroquinone in the month before the inclusion\n* Coeliac disease or allergy to gluten'}, 'identificationModule': {'nctId': 'NCT03878433', 'acronym': 'Glisodin', 'briefTitle': 'Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity. A Prospective Randomized Placebo-controlled Study', 'orgStudyIdInfo': {'id': '18-PP-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Drug', 'description': 'Glisodin : 2 capsules of GliSODin, 500mg of GliSODIn per day. Preferably to take in the morning during breakfast', 'interventionNames': ['Drug: Glisodin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No Drug', 'description': '2 capsules of PLacebo, 500mg of Placebo per day. Preferably to take in the morning during breakfastbo', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Glisodin', 'type': 'DRUG', 'description': '500 mg/day between 12 weeks', 'armGroupLabels': ['Drug']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Placebo group (20 patients) will receive 2 pills of placebo per day + sunscreen for 6 months', 'armGroupLabels': ['No Drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06001', 'city': 'Nice', 'state': 'Alpes-Maritime', 'country': 'France', 'facility': 'CHU de Nice - Dermatology', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Passeron Thierry, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatologie, CHU de Nice'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}