Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT00940992
Status:
COMPLETED
Last Update Posted:
2015-01-09
First Post:
2009-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of DER 45-EV Gel to Treat 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': 'ofra.levy-hacham@sol-gel.com', 'phone': '972-8-9313433', 'title': 'Ofra Levy-Hacham, Ph.D, VP of Quality Assurance', 'phoneExt': '3802', 'organization': 'Solgel'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'DER 45 EV Gel, 1%', 'description': 'DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks\n\nDER 45 EV: Topical application to face for 12 weeks', 'otherNumAtRisk': 32, 'otherNumAffected': 7, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle', 'description': 'Placebo Gel applied topically once a day for 12 weeks\n\nVehicle: Topical application to face for 12 weeks', 'otherNumAtRisk': 30, 'otherNumAffected': 11, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DER 45 EV Gel, 5%', 'description': 'DER 45 EV Gel, 5% applied topically once a day for 12 weeks\n\nDER 45 EV: Topical application to face for 12 weeks', 'otherNumAtRisk': 30, 'otherNumAffected': 7, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Application site dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Application site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA Version 14.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Investigator Global Assessment (IGA) Improvement From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DER 45 EV Gel, 1%', 'description': 'DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks\n\nDER 45 EV: Topical application to face for 12 weeks'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Placebo Gel applied topically once a day for 12 weeks\n\nVehicle: Topical application to face for 12 weeks'}, {'id': 'OG002', 'title': 'DER 45 EV Gel, 5%', 'description': 'DER 45 EV Gel, 5% applied topically once a day for 12 weeks\n\nDER 45 EV: Topical application to face for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '53.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12 / end of treatment', 'description': 'The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe).', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Inflammatory Lesion Counts From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DER 45 EV Gel, 1%', 'description': 'DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks\n\nDER 45 EV: Topical application to face for 12 weeks'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Placebo Gel applied topically once a day for 12 weeks\n\nVehicle: Topical application to face for 12 weeks'}, {'id': 'OG002', 'title': 'DER 45 EV Gel, 5%', 'description': 'DER 45 EV Gel, 5% applied topically once a day for 12 weeks\n\nDER 45 EV: Topical application to face for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.5', 'groupId': 'OG000', 'lowerLimit': '-27.5', 'upperLimit': '-15.4'}, {'value': '-8.8', 'groupId': 'OG001', 'lowerLimit': '-15.1', 'upperLimit': '-2.5'}, {'value': '-14.7', 'groupId': 'OG002', 'lowerLimit': '-21.0', 'upperLimit': '-8.4'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12 / end of treatment', 'description': 'The LS mean changes from Baseline in inflammatory lesion count at Week 12.', 'unitOfMeasure': 'Inflammatory lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DER 45 EV Gel, 1%', 'description': 'DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks\n\nDER 45 EV: Topical application to face for 12 weeks'}, {'id': 'FG001', 'title': 'Vehicle', 'description': 'Placebo Gel applied topically once a day for 12 weeks\n\nVehicle: Topical application to face for 12 weeks'}, {'id': 'FG002', 'title': 'DER 45 EV Gel, 5%', 'description': 'DER 45 EV Gel, 5% applied topically once a day for 12 weeks\n\nDER 45 EV: Topical application to face for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'subject request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'DER 45 EV Gel, 1%', 'description': 'DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks\n\nDER 45 EV: Topical application to face for 12 weeks'}, {'id': 'BG001', 'title': 'Vehicle', 'description': 'Placebo Gel applied topically once a day for 12 weeks\n\nVehicle: Topical application to face for 12 weeks'}, {'id': 'BG002', 'title': 'DER 45 EV Gel, 5%', 'description': 'DER 45 EV Gel, 5% applied topically once a day for 12 weeks\n\nDER 45 EV: Topical application to face for 12 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.0', 'spread': '13.50', 'groupId': 'BG000'}, {'value': '50.5', 'spread': '12.56', 'groupId': 'BG001'}, {'value': '52.2', 'spread': '12.66', 'groupId': 'BG002'}, {'value': '51.2', 'spread': '12.80', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'number of inflammatory lesions', 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '27.76', 'groupId': 'BG000'}, {'value': '19.9', 'spread': '8.64', 'groupId': 'BG001'}, {'value': '22.9', 'spread': '16.89', 'groupId': 'BG002'}, {'value': '23.9', 'spread': '19.76', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'minimum of 12 inflammatory lesions', 'unitOfMeasure': 'number of inflammatory lesion', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-31', 'studyFirstSubmitDate': '2009-07-14', 'resultsFirstSubmitDate': '2014-12-18', 'studyFirstSubmitQcDate': '2009-07-16', 'lastUpdatePostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-31', 'studyFirstPostDateStruct': {'date': '2009-07-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator Global Assessment (IGA) Improvement From Baseline', 'timeFrame': 'Baseline to Week 12 / end of treatment', 'description': 'The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe).'}, {'measure': 'Change in Inflammatory Lesion Counts From Baseline', 'timeFrame': 'Baseline to Week 12 / end of treatment', 'description': 'The LS mean changes from Baseline in inflammatory lesion count at Week 12.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rosacea']}, 'descriptionModule': {'briefSummary': 'To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, 18 years of age or older\n* Facial rosacea, with 12 or more inflammatory lesions (with no more than 2 nodules)\n* Mild, Moderate or Severe (2, 3 or 4) rating of rosacea on the IGA\n* Females of child-bearing potential must have negative urine pregnancy test result at baseline and must be willing to use an effective form of contraception throughout the study\n\nExclusion Criteria:\n\n* Subjects who are pregnant, breast feeding, or planning a pregnancy during the study\n* Allergy or sensitivity to ingredients in test product\n* Any dermatological conditions of the face that may interfere with study evaluations\n* Subjects unable to avoid or minimize exposure to factors that may exacerbate or trigger rosacea'}, 'identificationModule': {'nctId': 'NCT00940992', 'acronym': 'SGTDER45EV', 'briefTitle': 'A Study of DER 45-EV Gel to Treat Rosacea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sol-Gel Technologies, Ltd.'}, 'officialTitle': 'A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Dose-Range Study of DER 45 EV Gel, 1% and 5%, and Vehicle Gel in the Treatment of Rosacea', 'orgStudyIdInfo': {'id': 'SGT DER 45 EV 09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DER 45 EV Gel, 1%', 'description': 'DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks', 'interventionNames': ['Drug: DER 45 EV']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Placebo Gel applied topically once a day for 12 weeks', 'interventionNames': ['Drug: Vehicle']}, {'type': 'EXPERIMENTAL', 'label': 'DER 45 EV Gel, 5%', 'description': 'DER 45 EV Gel, 5% applied topically once a day for 12 weeks', 'interventionNames': ['Drug: DER 45 EV']}], 'interventions': [{'name': 'DER 45 EV', 'type': 'DRUG', 'description': 'Topical application to face for 12 weeks', 'armGroupLabels': ['DER 45 EV Gel, 1%', 'DER 45 EV Gel, 5%']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'Topical application to face for 12 weeks', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33140', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baumann Cosmetic & Research Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'FXM Research Corp', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta Centre for Dermatology and Skin', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Clinical Study Center', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Skin Search of Rochester, Inc', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Clinical Research Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'DermResearch, Inc', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77840', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'J & S Studies, Inc', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Premier Clinical Research', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53719', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Madison Skin and Research, Inc', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Ofra Levy-Hacham, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sponsor GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sol-Gel Technologies, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}