Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-28 @ 5:16 PM
Study NCT ID:
NCT01355458
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2011-05-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.graeber@galderma.com', 'phone': '609-860-8201', 'title': 'Michael Graeber, MD', 'organization': 'Galderma'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CD07805/47 Gel', 'otherNumAtRisk': 129, 'otherNumAffected': 0, 'seriousNumAtRisk': 129, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'otherNumAtRisk': 131, 'otherNumAffected': 0, 'seriousNumAtRisk': 131, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Accidental drug intake by child', 'notes': 'Study product was accidentally ingested by two young children of a single study subject.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CD07805/47 Gel'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'title': 'Day 29 / Hour 3', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 / Hour 6', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 / Hour 9', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 / Hour 12', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'GEE: Logit link function', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', 'description': 'Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population (i.e. Hours 3,6,9,12)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CD07805/47 Gel'}, {'id': 'FG001', 'title': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '131'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '127'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CD07805/47 Gel'}, {'id': 'BG001', 'title': 'Placebo'}, {'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': '117', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.5', 'spread': '11.76', 'groupId': 'BG000'}, {'value': '48.1', 'spread': '12.81', 'groupId': 'BG001'}, {'value': '48.8', 'spread': '12.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'dispFirstSubmitDate': '2012-07-23', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2011-05-16', 'dispFirstSubmitQcDate': '2012-07-23', 'resultsFirstSubmitDate': '2013-09-19', 'studyFirstSubmitQcDate': '2011-05-17', 'dispFirstPostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-09-19', 'studyFirstPostDateStruct': {'date': '2011-05-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Success', 'timeFrame': 'Day 29', 'description': 'Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rosacea'], 'conditions': ['Rosacea']}, 'descriptionModule': {'briefSummary': 'Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Male or female who is at least 18 years of age or older.\n2. A clinical diagnosis of facial rosacea.\n3. A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).\n4. A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).\n\nKey Exclusion Criteria:\n\n1. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.\n2. Presence of three (3) or more facial inflammatory lesions of rosacea.\n3. Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists.\n4. Less than 3 months stable dose treatment with tricyclic antidepressants, cardiac glycosides, beta blockers or other antihypertensive agents.\n5. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression."}, 'identificationModule': {'nctId': 'NCT01355458', 'briefTitle': 'Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Multicenter, Randomized Double-Blind, Vehicle-Controlled, Parallel Group Study to Demonstrate the Efficacy and Safety of CD07805/47 Gel Applied Topically Once Daily in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea', 'orgStudyIdInfo': {'id': 'RD.06.SPR.18140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD07805/47 gel', 'interventionNames': ['Drug: CD07805/47 gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CD07805/47 gel', 'type': 'DRUG', 'description': 'applied topically once daily', 'armGroupLabels': ['CD07805/47 gel']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'applied topically once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Research Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '48038', 'city': 'Clinton Township', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Center for Skin Care Research', 'geoPoint': {'lat': 42.58698, 'lon': -82.91992}}, {'zip': '08520', 'city': 'East Windsor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Windsor Dermatology', 'geoPoint': {'lat': 40.268, 'lon': -74.54043}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dermatology Consulting Services', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '97223', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Medical Research Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19034', 'city': 'Fort Washington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Philadelphia Institute of Dermatology', 'geoPoint': {'lat': 40.14178, 'lon': -75.20906}}, {'zip': '37922', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Skin Wellness Center', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '76011', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Arlington Center for Dermatology', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'DermResearch, Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '72230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermatology Treatment & Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Education & Research Foundation, Inc.', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': 'L3P 1A8', 'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Lynderm Research Inc', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'N8W 5L7', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Windsor Clinical Research Inc.', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'H2K 4L5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Innovaderm Research, Inc', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Michael Graeber, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Galderma R&D'}, {'name': 'William Abramovits, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology Treatment & Research Center'}, {'name': 'Robert Bissonette, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Innovaderm Research Inc.'}, {'name': 'Zoe Draelos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology Consulting Services, High Point NC'}, {'name': 'Kimberly Grande, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Skin Wellness Center'}, {'name': 'Michael Jarratt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Derm Research, PLLC'}, {'name': 'Charles Lynde, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lynderm Research Inc'}, {'name': 'Robert Matheson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Medical Research Center'}, {'name': 'Kappa Meadows, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Education & Research Foundation, Inc.'}, {'name': 'Angela Moore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arlington Center for Dermatology'}, {'name': 'David Nieves, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Windsor Dermatology'}, {'name': 'Andrew Pollack, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Philadelphia Institute of Dermatology'}, {'name': 'Howard Sofen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology Research Associates'}, {'name': 'Martin Steinhoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Daniel Stewart, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michigan Center for Skin Care Research'}, {'name': 'Jerry Tan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Windsor Clinical Research Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}