Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT03402893
Status:
COMPLETED
Last Update Posted:
2019-04-02
First Post:
2018-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}, {'id': 'D017495', 'term': 'Hyperpigmentation'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mmdermresearch@yahoo.com', 'phone': '5024519000', 'title': 'M. McAllister', 'organization': 'Skin Sciences, PLLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'screening to week 16', 'eventGroups': [{'id': 'EG000', 'title': 'Onexton Gel Application', 'description': 'Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face\n\nONEXTON Topical Gel: Onexton gel applied once daily to face', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 10, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'intermittent mid back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'group A beta hemolytic strep pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cellulitis right knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'unexpected menses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'facial tattoo tightening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'chest soreness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'serous otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'maxillary fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Investigator Global Assessment Scale for Severity of Facial Acne', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Onexton Gel Application', 'description': 'Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face\n\nONEXTON Topical Gel: Onexton gel applied once daily to face'}], 'classes': [{'title': 'week 4', 'categories': [{'title': 'clear', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'almost clear', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'mild', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'moderate', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'week 8', 'categories': [{'title': 'clear', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'almost clear', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'mild', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'week 16', 'categories': [{'title': 'clear', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'almost clear', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'mild', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4, Week 8, Week 16', 'description': "Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for facial acne; the IGA scale for acne reflects the Investigator's assessment of the severity of a subject's acne on a scale from 0 to 5 with 0 = Clear Skin, 1 = Almost Clear, 2 = Mild, 3 = Moderate severity, 4 = Severe, 5 = Very Severe Each of these gradations is based upon a lesion count by the Investigator.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Onexton Gel Application', 'description': 'Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face\n\nONEXTON Topical Gel: Onexton gel applied once daily to face'}], 'classes': [{'title': 'week 4', 'categories': [{'title': 'none', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'slight', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'mild', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'moderately severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'week 8', 'categories': [{'title': 'none', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'slight', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'mild', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'moderately severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'week 16', 'categories': [{'title': 'none', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'slight', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'mild', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'moderately severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4, Week 8, Week 16', 'description': "Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for severity of post inflammatory hyperpigmentation; the IGA scale of post-inflammatory hyperpigmentation reflects the Investigator's assessment of the severity of a subject's hyperpigmentation on a scale from 0 to 6 with 0 = None, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = moderately Severe, 5 = Severe, 6 = Very severe Each of these gradations is based upon the investigator's impression", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change in Inflammatory Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Onexton Gel Application', 'description': 'Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face\n\nONEXTON Topical Gel: Onexton gel applied once daily to face'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-35', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-55', 'spread': '22', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-76', 'spread': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4, Week 8, Week 16', 'description': 'The Investigator will count the number of facial (from hairline to mandibular line) inflammatory acne lesions at each study visit. Inflammatory lesions include papules, pustules and nodules.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change in Non-inflammatory Lesion Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Onexton Gel Application', 'description': 'Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face\n\nONEXTON Topical Gel: Onexton gel applied once daily to face'}], 'classes': [{'title': 'week 4', 'categories': [{'measurements': [{'value': '-21', 'spread': '22', 'groupId': 'OG000'}]}]}, {'title': 'week 8', 'categories': [{'measurements': [{'value': '-41', 'spread': '33', 'groupId': 'OG000'}]}]}, {'title': 'week 16', 'categories': [{'measurements': [{'value': '-62', 'spread': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4, Week 8, Week 16', 'description': 'The Investigator will count the number of facial non-inflammatory acne lesions at each study visit. these include open and closed comedones.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change in Total Lesion Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Onexton Gel Application', 'description': 'Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face\n\nONEXTON Topical Gel: Onexton gel applied once daily to face'}], 'classes': [{'title': 'week 4', 'categories': [{'measurements': [{'value': '-29', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': 'week 8', 'categories': [{'measurements': [{'value': '-51', 'spread': '21', 'groupId': 'OG000'}]}]}, {'title': 'week 16', 'categories': [{'measurements': [{'value': '-71', 'spread': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 4, Week 8, Week 16', 'description': 'The Investigator will count the number of facial inflammatory and non-inflammatory acne lesions at each study visit. These include papules, pustules, nodules, and open and closed comedones.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-Inflammatory Hyperpigmentation (PIH) Distribution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Onexton Gel Application', 'description': 'Onexton gel will be supplied to all subjects and applied once daily to the face\n\nONEXTON Topical Gel: Onexton gel applied once daily to face'}], 'classes': [{'title': 'Baseline', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': '5', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '6', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'week 4', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '5', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '6', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'week 8', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '5', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '6', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'week 16', 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': '5', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '6', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, Week 4, week 8, week 16', 'description': 'This measure as assessed by the Investigator seeks to quantify the extent to which post-inflammatory hyperpigmentation is distributed across the face, wherein 0= No PIH, 1=1-10% of the face affected, 2=11-20%, 3=21-30%, 4=31-40%, 5=41-50%, and 6=More than 50% of the face. Lower numbers reflect less severe disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Onexton Gel Application', 'description': 'Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face\n\nONEXTON Topical Gel: Onexton gel applied once daily to face'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '1 participant signed consent but failed screening'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Onexton Gel Application', 'description': 'Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face\n\nONEXTON Topical Gel: Onexton gel applied once daily to face'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Facial Investigator Global Assessment of Disease Severity', 'classes': [{'title': 'Moderate', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Clear', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Almost Clear', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'This assessment measures the severity of acne. The minimum value is 0/Absent and the maximum value is 5/severe. The data is reported as the percentage of patients who fall into each category at each time point.', 'unitOfMeasure': 'Participants'}, {'title': 'Inflammatory Lesion Count', 'classes': [{'categories': [{'measurements': [{'value': '14', 'spread': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'lesion', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Non-Inflammatory Lesion Count', 'classes': [{'categories': [{'measurements': [{'value': '15', 'spread': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'lesion', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Post Inflammatory Hyperpigmentation Distribution', 'classes': [{'title': '1-10%', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '11-20%', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '21-30%', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': '31-40%', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '41-50%', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'over 50%', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Each category describes the extent of facial distribution of post-inflammatory hyperpigmentation', 'unitOfMeasure': 'Participants'}, {'title': 'Total Lesion Count', 'classes': [{'categories': [{'measurements': [{'value': '29', 'spread': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'lesion', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Investigator Global Assessment of Severity of Facial Post Inflammatory Hyperpigmentation', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Slight', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Moderately Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'This assessment measures the severity of facial post-inflammatory hyperpigmentation. The minimum value is None and the maximum is Moderately Severe. The results are reported as the number of subjects falling under each category and the corresponding percentage of total participants falling under each category.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-12', 'size': 247020, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-01-25T14:17', 'hasProtocol': False}, {'date': '2017-01-31', 'size': 304149, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-01-30T14:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-19', 'studyFirstSubmitDate': '2018-01-11', 'resultsFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2018-01-17', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-30', 'studyFirstPostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator Global Assessment Scale for Severity of Facial Acne', 'timeFrame': 'Week 4, Week 8, Week 16', 'description': "Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for facial acne; the IGA scale for acne reflects the Investigator's assessment of the severity of a subject's acne on a scale from 0 to 5 with 0 = Clear Skin, 1 = Almost Clear, 2 = Mild, 3 = Moderate severity, 4 = Severe, 5 = Very Severe Each of these gradations is based upon a lesion count by the Investigator."}, {'measure': 'Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation', 'timeFrame': 'Week 4, Week 8, Week 16', 'description': "Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for severity of post inflammatory hyperpigmentation; the IGA scale of post-inflammatory hyperpigmentation reflects the Investigator's assessment of the severity of a subject's hyperpigmentation on a scale from 0 to 6 with 0 = None, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = moderately Severe, 5 = Severe, 6 = Very severe Each of these gradations is based upon the investigator's impression"}], 'secondaryOutcomes': [{'measure': 'Percent Change in Inflammatory Lesions', 'timeFrame': 'Week 4, Week 8, Week 16', 'description': 'The Investigator will count the number of facial (from hairline to mandibular line) inflammatory acne lesions at each study visit. Inflammatory lesions include papules, pustules and nodules.'}, {'measure': 'Percent Change in Non-inflammatory Lesion Count', 'timeFrame': 'Week 4, Week 8, Week 16', 'description': 'The Investigator will count the number of facial non-inflammatory acne lesions at each study visit. these include open and closed comedones.'}, {'measure': 'Percent Change in Total Lesion Count', 'timeFrame': 'week 4, Week 8, Week 16', 'description': 'The Investigator will count the number of facial inflammatory and non-inflammatory acne lesions at each study visit. These include papules, pustules, nodules, and open and closed comedones.'}, {'measure': 'Post-Inflammatory Hyperpigmentation (PIH) Distribution', 'timeFrame': 'baseline, Week 4, week 8, week 16', 'description': 'This measure as assessed by the Investigator seeks to quantify the extent to which post-inflammatory hyperpigmentation is distributed across the face, wherein 0= No PIH, 1=1-10% of the face affected, 2=11-20%, 3=21-30%, 4=31-40%, 5=41-50%, and 6=More than 50% of the face. Lower numbers reflect less severe disease.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris', 'Post Inflammatory Hyperpigmentation']}, 'descriptionModule': {'briefSummary': 'This is a single-center, open label pilot study. The study is comprised of 5 study visits; Screening, Baseline, and Weeks 4, 8, and 16. All subjects will receive Onexton at Baseline and be instructed to apply the gel once daily to the face. The investigators will evaluate Investigator Global Assessment of acne (IGA), total lesion count, inflammatory lesion count, non-inflammatory lesion count, Investigator Global Assessment of Post-Inflammatory Hyperpigmentation and distribution of Post-Inflammatory Hyperpigmentation, adverse events and concomitant medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\ni. Outpatient, subjects of skin of color, age 12 or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study;\n\nA female is considered of childbearing potential unless she is:\n\n* postmenopausal for at least 12 months prior to study drug administration\n* without a uterus and/or both ovaries; or\n* has been surgically sterile for at least 6 months prior to study drug administration\n\nReliable methods of contraception are:\n\n* intrauterine device in use ≥ 90 days prior to study drug administration;\n* barrier methods plus spermicide in use at least 14 days prior to study drug administration; or\n* vasectomized partner\n\n\\[Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.\\]\n\nii. Facial acne vulgaris in patients with skin of color (Fitzpatrick Type V \\& VI Supplement VI) characterized by the following:\n\n* IGA Score for acne vulgaris 3\n* IGA Score for PIH 3\n\niii. Able to understand and comply with the requirements of the study and sign Informed Consent /HIPAA Authorization forms\n\nExclusion Criteria:\n\ni. Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control\n\nii. Allergy/sensitivity to any component of the test treatment\n\niii. IGA score for acne of 2 (mild) or 4 (severe)\n\niv. IGA score for Post Inflammatory Hyperpigmentation of 2 (mild) or 4 (severe)\n\nv. Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I).\n\nvi. Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study\n\nvii. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris\n\nviii. Evidence of recent alcohol or drug abuse\n\nix. History of poor cooperation, non-compliance with medical treatment, or unreliability\n\nx. Exposure to an investigational study drug within 30 days of the Baseline Visit"}, 'identificationModule': {'nctId': 'NCT03402893', 'briefTitle': 'The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color', 'organization': {'class': 'OTHER', 'fullName': 'Derm Research, PLLC'}, 'officialTitle': 'The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color', 'orgStudyIdInfo': {'id': 'ONX-1701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single arm Onexton gel application', 'description': 'Onexton gel will be supplied to all subjects and applied once daily to the face', 'interventionNames': ['Drug: ONEXTON Topical Gel']}], 'interventions': [{'name': 'ONEXTON Topical Gel', 'type': 'DRUG', 'description': 'Onexton gel applied once daily to face', 'armGroupLabels': ['single arm Onexton gel application']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'DermResearch, PLLC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Derm Research, PLLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'L.H. Kircik, M.D.', 'investigatorAffiliation': 'Derm Research, PLLC'}}}}