Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-03-06 @ 5:55 AM
Study NCT ID:
NCT03105505
Status:
UNKNOWN
Last Update Posted:
2018-01-30
First Post:
2017-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Permethrin 5%, Fusidic Acid 1% and Synthomycine 5% for Demodex - Blepharitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005672', 'term': 'Fusidic Acid'}], 'ancestors': [{'id': 'D002775', 'term': 'Cholestadienols'}, {'id': 'D002774', 'term': 'Cholestadienes'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2017-03-28', 'studyFirstSubmitQcDate': '2017-04-03', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in demodex infestation in group A (permethrin 5%).', 'timeFrame': '2 months', 'description': 'significant decrease in demodex infestation in comparison to group B and C.'}, {'measure': 'Improvement in symptoms and complaints in group A.', 'timeFrame': '2 months', 'description': 'OSDI Questionnaires that describe the severity of the ocular surface disease condition are filled in each visit.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammation of the Eyelids']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate the effect of Permethrin 5% treatment on Signs and symptoms of Demodex-blepharitis in comparison to Synthomycine 5% and Fucithalmic (fusidic acid 1%) .', 'detailedDescription': '3 arms study. 75 patient total, 25 patients in each group.\n\nGroup A (study group) patients will apply facially Permethrin 5% every night for 3 months.\n\nGroup B patients will apply on the eyelids Fusidic acid 1% every night for 3 months.\n\nGroup C patients will apply on the eyelids Synthomycine 5% every night for 3 months\n\nFollow up Evaluation will be made after one week, one month, two months, three months, 4 months and half a year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Adult (Age ≥18Y) individuals clinically diagnosed with Demodex- blepharitis.\n\nExclusion Criteria:\n\n\\- Known sensitivity to all study medications or components. Pregnant women and individuals deemed unfit to provide informed consent. Systemic steroid use.'}, 'identificationModule': {'nctId': 'NCT03105505', 'briefTitle': 'The Efficacy of Permethrin 5%, Fusidic Acid 1% and Synthomycine 5% for Demodex - Blepharitis', 'organization': {'class': 'OTHER', 'fullName': 'Barzilai Medical Center'}, 'officialTitle': 'The Efficacy Of Lyclear (Permethrin 5%) Vs Fusidic Acid1% and Synthomycine 5% for Demodex -Blepharitis Treatment, Prospective-Randomized Trial.', 'orgStudyIdInfo': {'id': '003-16-BRZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Permethrin 5%', 'description': 'Contains permethrin 5% w/w (equivalent to 50 mg/g), formaldehyde solution 0.278% w/w and butylated hydroxytoluene (E321) 0.02% w/w.', 'interventionNames': ['Drug: Permethrin 5%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Synthomycine 5%,', 'description': 'Contains chloramphenicol 5%.', 'interventionNames': ['Drug: Synthomycine 5%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fusidic Acid 1%', 'description': 'Contains 1% w/w fusidic acid anhydrous (as the hemihydrates) and 0.011% w/w.', 'interventionNames': ['Drug: Fusidic Acid 1% M/R Eye Drops']}], 'interventions': [{'name': 'Permethrin 5%', 'type': 'DRUG', 'description': 'Facial skin application once a night for 3 months.', 'armGroupLabels': ['Permethrin 5%']}, {'name': 'Synthomycine 5%', 'type': 'DRUG', 'description': 'Eye ointment, eyelids and eyelashes application (chloramphenicol), once a night for 3 months.', 'armGroupLabels': ['Synthomycine 5%,']}, {'name': 'Fusidic Acid 1% M/R Eye Drops', 'type': 'DRUG', 'description': 'viscous eye drops application once a night for 3 months.', 'armGroupLabels': ['Fusidic Acid 1%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78278', 'city': 'Ashkelon', 'country': 'Israel', 'facility': 'Barzilai Medical Center', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barzilai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof Igor Kaiserman', 'investigatorFullName': 'Igor Kaiserman', 'investigatorAffiliation': 'Barzilai Medical Center'}}}}