Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-31 @ 3:09 AM
Study NCT ID:
NCT00907257
Status:
COMPLETED
Last Update Posted:
2012-02-15
First Post:
2009-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Different Use Regimens Using Two Acne Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014260', 'term': 'Triclosan'}], 'ancestors': [{'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'David.Lineberry@valeant.com', 'phone': '949-973-1153', 'title': 'David Lineberry', 'organization': 'Valeant Pharmaceuticals International, Inc'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Same Time of Day', 'description': '5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day', 'otherNumAtRisk': 123, 'otherNumAffected': 0, 'seriousNumAtRisk': 123, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Different Times of Day', 'description': '5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening', 'otherNumAtRisk': 124, 'otherNumAffected': 0, 'seriousNumAtRisk': 124, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Cardiac Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total Facial Acne Lesion Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Same Time of Day', 'description': '5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day'}, {'id': 'OG001', 'title': 'Different Times of Day', 'description': '5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening'}], 'classes': [{'categories': [{'measurements': [{'value': '39.74', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '40.02', 'spread': '1.62', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population, which includes all Intention to Treat (ITT) subjects who completed the 12 weeks of treatment and evaluations with no major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Same Time of Day', 'description': '5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day'}, {'id': 'OG001', 'title': 'Different Times of Day', 'description': '5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening'}], 'classes': [{'title': 'Inflammatory Lesions', 'categories': [{'measurements': [{'value': '14.6', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Non-Inflammatory Lesions', 'categories': [{'measurements': [{'value': '23.2', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '1.16', 'groupId': 'OG001'}]}]}, {'title': 'Total Lesions', 'categories': [{'measurements': [{'value': '37.4', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '38.1', 'spread': '1.68', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Between group comparison with Last Count Carried Forward (LOCF) of Inflammatory Facial Acne Lesion Count (the sum of papules and pustules), Non-Inflammatory Facial Acne Lesion Count (the sum of open and closed comedones), and their Total (the sum of Non-inflammatory and Inflammatory lesions).', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data set includes all Intent to Treat (ITT)subjects. Imputation technique was Last Observation Carried Forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Measurement of Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Same Time of Day', 'description': '5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day'}, {'id': 'OG001', 'title': 'Different Times of Day', 'description': '5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening'}], 'classes': [{'title': 'Clear / Almost Clear', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Improved Two Categories', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects achieving success according to dichotomized Investigator Global Assessment (IGA) using criteria of grades 0 or 1, or improvement of 2 grades from baseline score. Possible grades from 0-6 are described as follows:\n\n0 = Clear, 1=Almost Clear, 2=Mild, 3=Mild to Moderate, 4=Moderate, 5=Moderately Severe, 6=Severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT)population and imputation technique of Last Observations Carried Forward (LOCF)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Same Time of Day', 'description': '5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day'}, {'id': 'FG001', 'title': 'Different Times of Day', 'description': '5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '112'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Per IRB-Subject became vulnerable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '247', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Same Time of Day', 'description': '5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day'}, {'id': 'BG001', 'title': 'Different Times of Day', 'description': '5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.5', 'spread': '6.86', 'groupId': 'BG000'}, {'value': '18.6', 'spread': '6.94', 'groupId': 'BG001'}, {'value': '18.5', 'spread': '6.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '247', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fitzpatrick Score', 'classes': [{'title': 'I', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'II', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'III', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}, {'title': 'IV', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'V', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'VI', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Skin type is categorized according to the Fitzpatrick skin type scale, which ranges from very fair (skin type I) to very dark (skin type VI).', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 247}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-14', 'studyFirstSubmitDate': '2009-05-20', 'resultsFirstSubmitDate': '2010-12-22', 'studyFirstSubmitQcDate': '2009-05-21', 'lastUpdatePostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-22', 'studyFirstPostDateStruct': {'date': '2009-05-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total Facial Acne Lesion Count', 'timeFrame': 'Baseline to Week 12', 'description': 'Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals', 'timeFrame': 'Baseline to Week 12', 'description': 'Between group comparison with Last Count Carried Forward (LOCF) of Inflammatory Facial Acne Lesion Count (the sum of papules and pustules), Non-Inflammatory Facial Acne Lesion Count (the sum of open and closed comedones), and their Total (the sum of Non-inflammatory and Inflammatory lesions).'}, {'measure': 'Measurement of Success', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects achieving success according to dichotomized Investigator Global Assessment (IGA) using criteria of grades 0 or 1, or improvement of 2 grades from baseline score. Possible grades from 0-6 are described as follows:\n\n0 = Clear, 1=Almost Clear, 2=Mild, 3=Mild to Moderate, 4=Moderate, 5=Moderately Severe, 6=Severe.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acne', 'irritation', 'objective sensory methods'], 'conditions': ['Acne Vulgaris']}, 'referencesModule': {'references': [{'pmid': '20677537', 'type': 'RESULT', 'citation': 'Pariser D, Bucko A, Fried R, Jarratt MT, Kempers S, Kircik L, Lucky AW, Rafal E, Rendon M, Weiss J, Wilson DC, Rossi AB, Ramaswamy R, Nighland M. Tretinoin gel microsphere pump 0.04% plus 5% benzoyl peroxide wash for treatment of acne vulgaris: morning/morning regimen is as effective and safe as morning/evening regimen. J Drugs Dermatol. 2010 Jul;9(7):805-13.'}], 'seeAlsoLinks': [{'url': 'http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm', 'label': "FDA's Drug Finder"}]}, 'descriptionModule': {'briefSummary': 'A study to determine if using 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening.', 'detailedDescription': "Approximately 240 subjects will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, all subjects will receive RETIN-A MICRO PUMP 0.04% and a 5% Benzoyl Peroxide wash (OTC) for the entire 12-week treatment period. Subjects will be randomized to either both morning treatments (test) or to the morning/evening treatment (active control). Subjects will be assessed at baseline, at week 3, week 6 and again at the end of therapy, week 12 for number and type of individual lesions and safety. At selected sites, photographs will be taken at the same time points. At Week 12 subjects will be assessed for Investigator's Global Assessment of Acne Severity. The investigator will conduct all of the lesion counts, global assessments and safety assessments."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and non-pregnant or non-nursing females, 12 years or older, with facial acne vulgaris;\n* Minimum of 20 but no more than 50 inflammatory lesions (papules and pustules);\n* Minimum of 30 but no more than 100 facial non-inflammatory lesions (open and closed comedones);\n* Must have at least a rating of grade 3 on the Investigator Global severity scale at baseline\n\nExclusion Criteria:\n\n* Known sensitivity to any of the ingredients in the study medication;\n* Any nodulocystic acne lesions;\n* Use of acne devices or systemic therapy with antibiotics within two months prior to start and throughout the duration of the study;\n* Use of systemic therapy with retinoids within four months prior to study start and throughout the duration of the study;\n* Topical use of retinoids within two weeks prior to study start and throughout the duration of the study;\n* Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study;\n* If subject is taking birth control pills, she must be stabilized for at least three months prior to study start;\n* History of evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication;\n* Any significant medical conditions that could confound the interpretation of the study;\n* Excessive facial hair that may interfere with evaluations;\n* No use of tanning booths, sun lamps, etc.'}, 'identificationModule': {'nctId': 'NCT00907257', 'briefTitle': 'A Study of Different Use Regimens Using Two Acne Treatments', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Clinical Assessment of the Use of RETIN-A MICRO (Tretinoin Gel) Microsphere, 0.04% in a Pump Dispenser and a 5% Benzoyl Peroxide Wash Used in the Morning Compared to the Use of RETIN-A MICRO 0.04% Pump Nightly and a 5% Benzoyl Peroxide Wash in the Morning For the Treatment of Facial Acne Vulgaris', 'orgStudyIdInfo': {'id': 'CA-P-6270'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Same time of day', 'description': '5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day', 'interventionNames': ['Drug: benzoyl peroxide wash', 'Drug: Tretinoin gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Different times of day', 'description': '5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening', 'interventionNames': ['Drug: benzoyl peroxide wash', 'Drug: Tretinoin gel']}], 'interventions': [{'name': 'benzoyl peroxide wash', 'type': 'DRUG', 'otherNames': ['OXY Wash'], 'description': '5% benzoyl peroxide wash', 'armGroupLabels': ['Different times of day', 'Same time of day']}, {'name': 'Tretinoin gel', 'type': 'DRUG', 'otherNames': ['Retin-A Micro Pump'], 'description': '0.04% tretinoin gel', 'armGroupLabels': ['Different times of day', 'Same time of day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Skin Care Research, Inc.', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'International Dermatology Research, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30078', 'city': 'Snellville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Gwinnett Clinical Research', 'geoPoint': {'lat': 33.85733, 'lon': -84.01991}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Derm Research, PLLC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Clinical Study Center', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Academic Dermatology Associates', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11790', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'DermResearch Center of New York', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '45230', 'city': 'Cincinnatti', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dermatology Research Associates'}, {'zip': '19067', 'city': 'Yardley', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Yardley Dermatology Associates', 'geoPoint': {'lat': 40.24566, 'lon': -74.846}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'DermResearch, Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Education & Research Foundation, Inc.', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Clinical Research, Inc.', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Ana Rossi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Consumer and Personal Products Worldwide'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}