Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-04-07 @ 4:02 PM
Study NCT ID:
NCT03340961
Status:
COMPLETED
Last Update Posted:
2021-03-01
First Post:
2017-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules
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'}]}, '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': 'Srinivassidgiddi@drreddys.com', 'phone': '908-458-5362', 'title': 'Dr. Srinivas Sidgiddi, Senior Director', 'organization': "Dr. Reddy's Lab, INC"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit.', 'description': "Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded.\n\nAEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.", 'eventGroups': [{'id': 'EG000', 'title': 'DFD-29 Extended Release Capsules (40 mg)', 'description': 'DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.\n\nDFD-29 Extended Release Capsules (40 mg): Oral Treatment', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 37, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'DFD-29 Extended Release Capsules (20 mg)', 'description': 'DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.\n\nDFD-29 Extended Release Capsules (20 mg): Oral Treatment', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 33, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Oraycea® (Doxycycline) Capsules', 'description': 'Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.\n\nOraycea® (doxycycline) Capsules: Oral Treatment', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 27, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Placebo Capsules', 'description': 'Placebo Capsules once per day for 16 weeks.\n\nPlacebo Capsules: Oral Treatment', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 35, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 47, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 35, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 37, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 29, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'notes': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Atrial fibrillation', 'notes': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Lymphoma', 'notes': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Papilloma', 'notes': 'Papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Retinal detachment', 'notes': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Investigator Global Assessment (IGA) 0=Clear, 1=Near Clear, 2=Mild, 3=Moderate, 4=Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DFD-29 Extended Release Capsules (40 mg)', 'description': 'DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.\n\nDFD-29 Extended Release Capsules (40 mg): Oral Treatment'}, {'id': 'OG001', 'title': 'DFD-29 Extended Release Capsules (20 mg)', 'description': 'DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.\n\nDFD-29 Extended Release Capsules (20 mg): Oral Treatment'}, {'id': 'OG002', 'title': 'Oraycea® (Doxycycline) Capsules', 'description': 'Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.\n\nOraycea® (doxycycline) Capsules: Oral Treatment'}, {'id': 'OG003', 'title': 'Placebo Capsules', 'description': 'Placebo Capsules once per day for 16 weeks.\n\nPlacebo Capsules: Oral Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks', 'description': "Proportion of subjects with Investigator Global Assessment (IGA) 'treatment success' - Grade 0 or 1 at the end of study with at least 2 grade reduction from Baseline to Week 16.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS (full analysis set) included all subjects that had at least one post Baseline efficacy assessment.'}, {'type': 'PRIMARY', 'title': 'Total Inflammatory Lesion Count Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DFD-29 Extended Release Capsules (40 mg)', 'description': 'DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.\n\nDFD-29 Extended Release Capsules (40 mg): Oral Treatment'}, {'id': 'OG001', 'title': 'DFD-29 Extended Release Capsules (20 mg)', 'description': 'DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.\n\nDFD-29 Extended Release Capsules (20 mg): Oral Treatment'}, {'id': 'OG002', 'title': 'Oraycea® (Doxycycline) Capsules', 'description': 'Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.\n\nOraycea® (doxycycline) Capsules: Oral Treatment'}, {'id': 'OG003', 'title': 'Placebo Capsules', 'description': 'Placebo Capsules once per day for 16 weeks.\n\nPlacebo Capsules: Oral Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.2', 'spread': '9.72', 'groupId': 'OG000'}, {'value': '-12.6', 'spread': '12.92', 'groupId': 'OG001'}, {'value': '-10.5', 'spread': '15.18', 'groupId': 'OG002'}, {'value': '-7.3', 'spread': '10.12', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 Weeks', 'description': 'The total inflammatory lesion count is carried out by visual inspection by the Investigator at every study visit from Screening up to Week 16 (or at early termination). Inflammatory lesions will be recorded on a diagram of a human face, divided in 4 quadrants.', 'unitOfMeasure': 'Count of lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population'}, {'type': 'SECONDARY', 'title': 'Median Change in RosaQoL (Rosacea Quality of Life) Score From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DFD-29 Extended Release Capsules (40 mg)', 'description': 'DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.\n\nDFD-29 Extended Release Capsules (40 mg): Oral Treatment'}, {'id': 'OG001', 'title': 'DFD-29 Extended Release Capsules (20 mg)', 'description': 'DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.\n\nDFD-29 Extended Release Capsules (20 mg): Oral Treatment'}, {'id': 'OG002', 'title': 'Oraycea® (Doxycycline) Capsules', 'description': 'Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.\n\nOraycea® (doxycycline) Capsules: Oral Treatment'}, {'id': 'OG003', 'title': 'Placebo Capsules', 'description': 'Placebo Capsules once per day for 16 weeks.\n\nPlacebo Capsules: Oral Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.0', 'groupId': 'OG000', 'lowerLimit': '-53', 'upperLimit': '11'}, {'value': '-8.0', 'groupId': 'OG001', 'lowerLimit': '-34', 'upperLimit': '8'}, {'value': '-3.0', 'groupId': 'OG002', 'lowerLimit': '-30', 'upperLimit': '25'}, {'value': '-1.0', 'groupId': 'OG003', 'lowerLimit': '-37', 'upperLimit': '19'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Median change in the score from Baseline to Week 16', 'description': 'The RosaQoL assessment is carried out by the Investigator using the validated RosaQoL questionnaire, at every study visit from Screening up to Week 16 (or at early termination). The RosaQol tool has 21 questions related to the impact that Rosacea has on various dimensions influencing quality of life. Each question is graded from 1 (Never) - 5 (All the time), thus leading to a minimum score of 21 (21 x 1) to a maximum score of 105 (21 x 5) per subject at every visit. Higher the score, poorer is the quality of life. This outcome measured the change in the score from Baseline to Week 16.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DFD-29 Extended Release Capsules (40 mg)', 'description': 'DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.\n\nDFD-29 Extended Release Capsules (40 mg): Oral Treatment'}, {'id': 'FG001', 'title': 'DFD-29 Extended Release Capsules (20 mg)', 'description': 'DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.\n\nDFD-29 Extended Release Capsules (20 mg): Oral Treatment'}, {'id': 'FG002', 'title': 'Oraycea® (Doxycycline) Capsules', 'description': 'Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.\n\nOraycea® (doxycycline) Capsules: Oral Treatment'}, {'id': 'FG003', 'title': 'Placebo Capsules', 'description': 'Placebo Capsules once per day for 16 weeks.\n\nPlacebo Capsules: Oral Treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Use of prohibited treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Wrongful enrollment (I/E criteria not me', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Subject developed an exclusion criterion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '205', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'DFD-29 Extended Release Capsules (40 mg)', 'description': 'DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.\n\nDFD-29 Extended Release Capsules (40 mg): Oral Treatment'}, {'id': 'BG001', 'title': 'DFD-29 Extended Release Capsules (20 mg)', 'description': 'DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.\n\nDFD-29 Extended Release Capsules (20 mg): Oral Treatment'}, {'id': 'BG002', 'title': 'Oraycea® (Doxycycline) Capsules', 'description': 'Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.\n\nOraycea® (doxycycline) Capsules: Oral Treatment'}, {'id': 'BG003', 'title': 'Placebo Capsules', 'description': 'Placebo Capsules once per day for 16 weeks.\n\nPlacebo Capsules: Oral Treatment'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '167', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.8', 'spread': '15.05', 'groupId': 'BG000'}, {'value': '51.1', 'spread': '13.13', 'groupId': 'BG001'}, {'value': '51.6', 'spread': '12.94', 'groupId': 'BG002'}, {'value': '52.5', 'spread': '12.92', 'groupId': 'BG003'}, {'value': '50.5', 'spread': '13.64', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '124', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '205', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '205', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Total Inflammatory Lesion Count', 'classes': [{'categories': [{'measurements': [{'value': '23.8', 'spread': '8.69', 'groupId': 'BG000'}, {'value': '24.5', 'spread': '9.49', 'groupId': 'BG001'}, {'value': '23.8', 'spread': '7.56', 'groupId': 'BG002'}, {'value': '24.0', 'spread': '8.40', 'groupId': 'BG003'}, {'value': '24.0', 'spread': '8.51', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Number of lesions', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The FAS (full analysis set) had all subjects who had at least one post Baseline efficacy assessment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-06', 'size': 356839, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-09T10:57', 'hasProtocol': False}, {'date': '2018-10-02', 'size': 1768569, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-09T10:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Each subject will be allocated to one of the following treatment groups, receiving 1 capsule once daily in the morning for 16 weeks:\n\n1. DFD-29 Extended Release Capsules (40 mg)\n2. DFD-29 Extended Release Capsules (20 mg)\n3. Doxycycline Modified Release Hard Capsules (40 mg)\n4. Placebo Capsules'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-04', 'studyFirstSubmitDate': '2017-10-19', 'resultsFirstSubmitDate': '2020-03-24', 'studyFirstSubmitQcDate': '2017-11-09', 'lastUpdatePostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-11', 'studyFirstPostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator Global Assessment (IGA) 0=Clear, 1=Near Clear, 2=Mild, 3=Moderate, 4=Severe', 'timeFrame': '16 weeks', 'description': "Proportion of subjects with Investigator Global Assessment (IGA) 'treatment success' - Grade 0 or 1 at the end of study with at least 2 grade reduction from Baseline to Week 16."}, {'measure': 'Total Inflammatory Lesion Count Reduction', 'timeFrame': '16 Weeks', 'description': 'The total inflammatory lesion count is carried out by visual inspection by the Investigator at every study visit from Screening up to Week 16 (or at early termination). Inflammatory lesions will be recorded on a diagram of a human face, divided in 4 quadrants.'}], 'secondaryOutcomes': [{'measure': 'Median Change in RosaQoL (Rosacea Quality of Life) Score From Baseline to Week 16', 'timeFrame': 'Median change in the score from Baseline to Week 16', 'description': 'The RosaQoL assessment is carried out by the Investigator using the validated RosaQoL questionnaire, at every study visit from Screening up to Week 16 (or at early termination). The RosaQol tool has 21 questions related to the impact that Rosacea has on various dimensions influencing quality of life. Each question is graded from 1 (Never) - 5 (All the time), thus leading to a minimum score of 21 (21 x 1) to a maximum score of 105 (21 x 5) per subject at every visit. Higher the score, poorer is the quality of life. This outcome measured the change in the score from Baseline to Week 16.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rosacea']}, 'referencesModule': {'references': [{'pmid': '35096250', 'type': 'DERIVED', 'citation': 'Tsianakas A, Pieber T, Baldwin H, Feichtner F, Alikunju S, Gautam A, Shenoy S, Singh P, Sidgiddi S. Minocycline Extended-Release Comparison with Doxycycline for the Treatment of Rosacea: A Randomized, Head-to-Head, Clinical Trial. J Clin Aesthet Dermatol. 2021 Dec;14(12):16-23.'}]}, 'descriptionModule': {'briefSummary': "Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment (IGA, modified scale without erythema), Clinician's Erythema Assessment (CEA), and on inflammatory lesion counts at Weeks 4, 8, 12 and 16 in comparison to Baseline.", 'detailedDescription': "Two hundred (200) male and female subjects with papulopustular rosacea will be enrolled to get 176 completed subjects (forty-four (44) completers each in groups 1 to 4).\n\nAfter assessing eligibility during an up to 28 days screening period, 200 subjects will be enrolled in the study (fifty subjects each in groups 1 to 4). Subject visits are scheduled at Screening, Baseline (Day 1), and Weeks 4, 8, 12 and 16.\n\nClinical assessments of efficacy will be conducted based on Investigator's Global Assessment (IGA, modified scale without erythema), Clinician's Erythema Assessment (CEA), and on inflammatory lesion counts at Weeks 4, 8, 12 and 16 in comparison to Baseline. Additionally, high sensitivity C-reactive protein (hs-CRP) in the blood will be assessed at Baseline, and at Week 16 to explore any impact of the treatment on the inflammatory pathology."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects must be able to understand the requirements of the study and be willing to give written informed consent.\n2. Male and female subjects aged 18 years and above.\n3. Subjects, any gender or ethnicity (and of Fitzpatrick skin type I - III), must be in good general health as determined by the Investigator.\n4. Subjects must have a clinical diagnosis of papulopustular rosacea, IGA grade 2 - 4.\n5. Subjects must have 10 - 40 (both inclusive) inflammatory lesions (papules and pustules) of rosacea over the face.\n6. Subjects must have not more than 2 nodules.\n7. Subjects with moderate to severe erythema with a total score of 5 - 20 on the CEA scale.\n8. Females must have a negative urine pregnancy test at the screening and baseline visit.\n9. Females must either be postmenopausal with no menses for at least 12 months or surgically sterile (hysterectomy or tubal ligation) or agree to use a highly effective method of contraception with a pearl index of \\<1% up to 1 month after last dose.\n10. Subjects must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).\n\nExclusion Criteria:\n\n1. Females who are pregnant or nursing or planning to become pregnant during the study.\n2. Male whose female partner is planning to conceive a child.\n3. Subjects who have been treated for rosacea within the 30 days prior to the Baseline Visit (e.g. metronidazole, azelaic acid, doxycycline or brimonidine).\n4. Subjects who have been treated with systemic retinoids within 6 months prior to the Baseline visit.\n5. Subjects who have participated in a trial involving any investigational product in the 90 days prior to the Baseline Visit.\n6. Subjects with any disease or medical condition that would interfere with the study outcome or place the subject at undue risk.\n7. Subjects who use or have used systemic steroids within the 30 days prior to the Baseline Visit or any other immunosuppressive medication.\n8. Subjects who are on anti-coagulants or those who are likely to require anti-coagulants during the study period.\n9. History of drug or alcohol abuse in the last year.'}, 'identificationModule': {'nctId': 'NCT03340961', 'briefTitle': 'A Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules', 'organization': {'class': 'INDUSTRY', 'fullName': "Dr. Reddy's Laboratories Limited"}, 'officialTitle': 'A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea Over 16 Weeks', 'orgStudyIdInfo': {'id': 'DFD-29-CD-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DFD-29 Extended Release Capsules (40 mg)', 'description': 'DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.', 'interventionNames': ['Drug: DFD-29 Extended Release Capsules (40 mg)']}, {'type': 'EXPERIMENTAL', 'label': 'DFD-29 Extended Release Capsules (20 mg)', 'description': 'DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.', 'interventionNames': ['Drug: DFD-29 Extended Release Capsules (20 mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Oraycea® (doxycycline) Capsules', 'description': 'Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.', 'interventionNames': ['Drug: Oraycea® (doxycycline) Capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Capsules', 'description': 'Placebo Capsules once per day for 16 weeks.', 'interventionNames': ['Drug: Placebo Capsules']}], 'interventions': [{'name': 'DFD-29 Extended Release Capsules (40 mg)', 'type': 'DRUG', 'description': 'Oral Treatment', 'armGroupLabels': ['DFD-29 Extended Release Capsules (40 mg)']}, {'name': 'DFD-29 Extended Release Capsules (20 mg)', 'type': 'DRUG', 'description': 'Oral Treatment', 'armGroupLabels': ['DFD-29 Extended Release Capsules (20 mg)']}, {'name': 'Oraycea® (doxycycline) Capsules', 'type': 'DRUG', 'description': 'Oral Treatment', 'armGroupLabels': ['Oraycea® (doxycycline) Capsules']}, {'name': 'Placebo Capsules', 'type': 'DRUG', 'description': 'Oral Treatment', 'armGroupLabels': ['Placebo Capsules']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bad Bentheim', 'country': 'Germany', 'facility': 'Site 13', 'geoPoint': {'lat': 52.30066, 'lon': 7.15763}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Site 07', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Site 14', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'Site 09', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Buxtehude', 'country': 'Germany', 'facility': 'Site 05', 'geoPoint': {'lat': 53.46994, 'lon': 9.68968}}, {'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Site 15', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'city': 'Dülmen', 'country': 'Germany', 'facility': 'Site 03', 'geoPoint': {'lat': 51.83149, 'lon': 7.28075}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Site 08', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Mahlow', 'country': 'Germany', 'facility': 'Site 11', 'geoPoint': {'lat': 52.36017, 'lon': 13.40954}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Site 06', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Osnabrück', 'country': 'Germany', 'facility': 'Site 10', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'city': 'Pommelsbrunn', 'country': 'Germany', 'facility': 'Site 01', 'geoPoint': {'lat': 49.50437, 'lon': 11.51101}}, {'city': 'Potsdam', 'country': 'Germany', 'facility': 'Site 04', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}, {'city': 'Wuppertal', 'country': 'Germany', 'facility': 'Site 02', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}], 'overallOfficials': [{'name': 'Srinivas Sidgiddi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director-Clinical Development'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Reddy's Laboratories Limited", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}