Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-03-16 @ 1:51 AM
Study NCT ID:
NCT02236403
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2014-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Demodex Blepharitis With Ivermectin Gel 0.1% Plus Metronidazole 1%
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001762', 'term': 'Blepharitis'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007559', 'term': 'Ivermectin'}, {'id': 'C052102', 'term': '22,23-dihydroavermectin B(1)a'}, {'id': 'C034045', 'term': 'avermectin H2B1b'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-03', 'studyFirstSubmitDate': '2014-09-08', 'studyFirstSubmitQcDate': '2014-09-08', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Erradication of Demodex mites', 'timeFrame': '2 months', 'description': 'Reduction in mites count after treatment compared to baseline data. If mites are not observed in the last visit a complete eradication will be considered. Patients with one or more mites will be considered as a incomplete eradication'}], 'secondaryOutcomes': [{'measure': 'Change in lid margin rednes and bulbar conjunctival hyperemia categorized from 0 (none) to 3 (severe) according to the next score', 'timeFrame': '2 months', 'description': 'Change in lid margin rednes and bulbar conjunctival hyperemia categorized from 0 (none) to 3 (severe) according to the next score\n\n* None (0) = normal\n* Mild (1) = Slight localized injection\n* Moderate (2) = pink color\n* Severe (3) = dark redness'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Blepharitis , Demodex, Ivermectin, Metronidazole'], 'conditions': ['Chronic Blepharitis']}, 'descriptionModule': {'briefSummary': 'Blepharitis is a endemic inflammatory disease caused mainly by Demodex folliculorum and Demodex Brevis, This mites are often associated with anaerobic bacteria that produces a skin inflammation, so a intervention that reduces the number of mites and bacteria would be desirable. Ivermectin a macrolid compound have demonstrated activity against scabies and lice in humans and in animals and a single application have show a good response in lice eradication.\n\nIn this study , investigators will determinate the security and effectiveness of this compound in the eradication of mites'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients with symptomatic Demodex blepharitis for duration of at least 3 months.\n\n * Age range: 18 yeras and older.\n * Both genders and all ethnic groups comparable with the local community.\n * Able to understand and willing to sign a written informed consent\n * Able and willing to cooperate with the investigational plan.\n * Able and willing to complete all mandatory follow-up visits.\n\nExclusion Criteria:\n\n* • Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.\n\n * Children under 18.\n * Pregnant women or expecting to be pregnant during the study.\n * Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.\n * Concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes).\n * Concomitant use of systemic antibiotics or steroids.\n * Contact lens wear\n * Active ocular infection or allergy\n * Unable to close eyes or uncontrolled blinking Previous allergic reaction to metronidazole and / or ivermectin'}, 'identificationModule': {'nctId': 'NCT02236403', 'briefTitle': 'Treatment of Demodex Blepharitis With Ivermectin Gel 0.1% Plus Metronidazole 1%', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Nacional de Colombia'}, 'officialTitle': 'Diagnosis of Demodex Blapharitis and Treatment With Ivermectin Gel 0.1%/ Metronidazole 1%', 'orgStudyIdInfo': {'id': 'demodex0.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ivermectin 0.1% Metronidazole 1%', 'description': '30 patients will receive the treatment and at 15 days a second visit will be done and changes in mite counts will be determinated and correlated with symtoms and signs.', 'interventionNames': ['Drug: Ivermectin 0.1% Metronidazole 1%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': '30 volunters with no signs of blepharitis and with eyelashes with no demodex .None intervention. Symptoms and signs will be compared with experimental group', 'interventionNames': ['Other: None intervention']}], 'interventions': [{'name': 'Ivermectin 0.1% Metronidazole 1%', 'type': 'DRUG', 'otherNames': ['22,23-dihydroavermectin B1a + 22,23-dihydroavermectin B1b'], 'armGroupLabels': ['Ivermectin 0.1% Metronidazole 1%']}, {'name': 'None intervention', 'type': 'OTHER', 'description': 'Volunteers with no signs of blepharitis and with eyelashes with no demodex. Symptoms and signs will be compared with experimental group', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Hospital de Engativa', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Nacional de Colombia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}