Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT00560703
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2007-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Patients With Blepharitis and Facial Rosacea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001762', 'term': 'Blepharitis'}, {'id': 'D000092663', 'term': 'Meibomitis'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D002214', 'term': 'Capsules'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@galderma.com', 'phone': '609-409-7701', 'title': 'Michael Graeber', 'organization': 'Organization: Galderma R&D, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'COL-101 (Doxycycline, USP) Capsules', 'description': '40 MG, Once per day for 84 days', 'otherNumAtRisk': 46, 'otherNumAffected': 5, 'seriousNumAtRisk': 46, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Sugar capsule, once per day for 84 days', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}], 'seriousEvents': [{'term': 'Migraine headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': "non-hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Bulbar Conjunctival Hyperemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COL-101 (Doxycycline, USP) Capsules', 'description': '40 MG, Once per day for 84 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sugar capsule, once per day for 84 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.797', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.707', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.578', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Power calculation for this endpoint was driven by the assumptions made for the OSDI analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Bulbar conjunctival hyperemia will be assessed using an ordered categorical value ranging from 0 (Clear) to 4 (Severe). Hyperemia is graded on the following scale and half scores are acceptable:\n\nNone (0) = normal Mild (1) = slight localized injection Moderate (2) = pink color Severe (3) = red color Very Severe (4) = marked dark redness', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-04'}, {'type': 'PRIMARY', 'title': 'Change in Ocular Surface Disease Index (OSDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COL-101 (Doxycycline, USP) Capsules', 'description': '40 MG, Once per day for 84 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sugar capsule, once per day for 84 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.15', 'spread': '14.002', 'groupId': 'OG000'}, {'value': '-8.70', 'spread': '17.719', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.293', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'It was anticipated that the difference between the treatment groups in mean reduction from baseline in OSDI scores will be approximately 7 points. A pooled standard deviation of 9.0 for the mean change from baseline OSDI score is expected. Under those assumptions a total of approximately 63 evaluable patients (42 COL-101 patients and 21 placebo patients) is sufficient to provide 80% power. The planned enrolment should provide enough evaluable patients to meet these assumptions.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'OSDI is calculated based following formula using 12-question Ocular Surface Disease questionnaire (with each question scored 0-4):\n\nOSDI = (D/E)x25, where D = Sum of all scores for questions answered E = Total number of questions answered (not including questions answered NA)\n\nRange of OSDI is 0 to 100 (higher score indicates worse condition).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'COL-101 (Doxycycline, USP) Capsules', 'description': '40 MG, Once per day for 84 days'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Sugar capsule, once per day for 84 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment time was approximately 6 months in 8 US clinics.', 'preAssignmentDetails': 'Subjects were screened for eligibility within 6 weeks prior to the baseline visit. This 12-week study employed a two-treatment, parallel-group design with subjects randomized in a 2:1 ratio to active drug or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'COL-101 (Doxycycline, USP) Capsules', 'description': '40 MG, Once per day for 84 days'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Sugar capsule, once per day for 84 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'spread': '13.46', 'groupId': 'BG000'}, {'value': '58.2', 'spread': '14.27', 'groupId': 'BG001'}, {'value': '55.7', 'spread': '13.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2007-11-16', 'resultsFirstSubmitDate': '2011-04-28', 'studyFirstSubmitQcDate': '2007-11-16', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-12-09', 'studyFirstPostDateStruct': {'date': '2007-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Bulbar Conjunctival Hyperemia', 'timeFrame': 'Baseline to Week 12', 'description': 'Bulbar conjunctival hyperemia will be assessed using an ordered categorical value ranging from 0 (Clear) to 4 (Severe). Hyperemia is graded on the following scale and half scores are acceptable:\n\nNone (0) = normal Mild (1) = slight localized injection Moderate (2) = pink color Severe (3) = red color Very Severe (4) = marked dark redness'}, {'measure': 'Change in Ocular Surface Disease Index (OSDI)', 'timeFrame': 'Baseline to Week 12', 'description': 'OSDI is calculated based following formula using 12-question Ocular Surface Disease questionnaire (with each question scored 0-4):\n\nOSDI = (D/E)x25, where D = Sum of all scores for questions answered E = Total number of questions answered (not including questions answered NA)\n\nRange of OSDI is 0 to 100 (higher score indicates worse condition).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Blepharitis', 'Meibomianitis', 'Dry Eye']}, 'descriptionModule': {'briefSummary': 'To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* blepharitis\n* facial rosacea\n\nExclusion Criteria:\n\n* pregnant or nursing women\n* allergy to tetracyclines\n* recent eye surgery\n* past or current use of isotretinoin\n* patients who are achlorhydric\n* patients who have had gastric by-pass surgery'}, 'identificationModule': {'nctId': 'NCT00560703', 'briefTitle': 'Treatment of Patients With Blepharitis and Facial Rosacea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'Efficacy and Safety of COL-101 for the Treatment of Blepharitis in Patients With Facial Rosacea', 'orgStudyIdInfo': {'id': 'COL-101-BLEPH-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'COL-101 (doxycycline, USP) capsules', 'description': 'COL-101', 'interventionNames': ['Drug: COL-101 (doxycycline, USP) capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Sugar capsule', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'COL-101 (doxycycline, USP) capsules', 'type': 'DRUG', 'description': '40mg, once per day for 84 days', 'armGroupLabels': ['COL-101 (doxycycline, USP) capsules']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'sugar capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72212', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Pleasant Valley Ophthalmology', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '34103', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Warren Scherer, MD', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Lions Eye Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11563', 'city': 'Lynbrook', 'state': 'New York', 'country': 'United States', 'facility': 'Marguerite McDonald, MD', 'geoPoint': {'lat': 40.65483, 'lon': -73.6718}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Dean McGee Eye Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19004', 'city': 'Bala-Cynwyd', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Anita Nevyas-Wallace, MD', 'geoPoint': {'lat': 40.00761, 'lon': -75.23407}}, {'zip': '84041', 'city': 'Layton', 'state': 'Utah', 'country': 'United States', 'facility': 'Tanner Clinic', 'geoPoint': {'lat': 41.06022, 'lon': -111.97105}}], 'overallOfficials': [{'name': 'Michael Graeber, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galderma R&D'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}