Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-27 @ 11:25 PM
Study NCT ID:
NCT01831960
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2013-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris
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': 'C496269', 'term': 'Clascoterone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'r&d@cassiopea.com', 'phone': '+39 02 868 911 24', 'title': 'Cassiopea R&D', 'organization': 'Cassiopea, SpA'}, 'certainAgreement': {'otherDetails': 'The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 18 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 60 days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '14 Days', 'description': 'Any treatment emergent AEs ongoing at the end of the treatment period (Day 14) were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Cortexolone 17α-Propionate (Cohort 1)', 'description': 'Cohort 1 enrolled adults subjects. Topical cream, 1.0% concentration, applied every twelve hours.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 5, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cortexolone 17α-Propionate (Cohort 2)', 'description': 'Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 3, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Application site folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'ACTH stimulation test abnormal', 'notes': 'Adrenocorticotropic Hormone (ACTH) stimulation testing is conducted by the Cosyntropin Stimulation Test.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HPA Axis Response to Cosyntropin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cortexolone 17α-Propionate (Cohort 1)', 'description': 'Cohort 1 enrolled adults subjects. Topical cream, 1.0% concentration, applied every twelve hours.'}, {'id': 'OG001', 'title': 'Cortexolone 17α-Propionate (Cohort 2)', 'description': 'Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.'}], 'classes': [{'title': 'Baseline (pre-CST)', 'categories': [{'measurements': [{'value': '17.0', 'spread': '5.98', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '4.71', 'groupId': 'OG001'}]}]}, {'title': 'Baseline (post-CST)', 'categories': [{'measurements': [{'value': '27.7', 'spread': '3.43', 'groupId': 'OG000'}, {'value': '24.6', 'spread': '3.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (pre-CST)', 'categories': [{'measurements': [{'value': '18.1', 'spread': '7.02', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '3.98', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (post-CST)', 'categories': [{'measurements': [{'value': '26.7', 'spread': '5.56', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '2.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin injection (Cosyntropin Stimulation Test - CST). Prior to CST, a pre-CST blood sample is taken between 7AM to 9AM. Thirty minutes after CST, a post-CST blood sample is collected. HPA axis suppression is defined as a post-stimulation serum cortisol level ≤ 18 μg/dL at Day 14.', 'unitOfMeasure': 'mcg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'PK Profiles (Cmax) of Cortexolone 17α-propionate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cortexolone 17α-Propionate (Cohort 1)', 'description': 'Cohort 1 enrolled adults subjects. Topical cream, 1.0% concentration, applied every twelve hours.'}, {'id': 'OG001', 'title': 'Cortexolone 17α-Propionate (Cohort 2)', 'description': 'Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.'}], 'classes': [{'title': 'Cmax - Day 1 (ng/mL)', 'categories': [{'measurements': [{'value': '3.23', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '3.58', 'spread': '4.30', 'groupId': 'OG001'}]}]}, {'title': 'Cmax - Day 14 (ng/mL)', 'categories': [{'measurements': [{'value': '4.46', 'spread': '3.00', 'groupId': 'OG000'}, {'value': '4.61', 'spread': '4.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'Max concentration (Cmax) of cortexolone 17α-propionate in plasma following the first application (i.e., Day 1, 0-12 hours) and last application (i.e., Day 14, 0-12 hours).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'PK Profiles (AUC) of Cortexolone 17α-propionate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cortexolone 17α-Propionate (Cohort 1)', 'description': 'Topical cream, 1.0% concentration, applied every twelve hours.'}, {'id': 'OG001', 'title': 'Cortexolone 17α-Propionate (Cohort 2)', 'description': 'Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.'}], 'classes': [{'title': 'AUCτ - Day 1', 'categories': [{'measurements': [{'value': '22.02', 'spread': '13.67', 'groupId': 'OG000'}, {'value': '22.55', 'spread': '22.57', 'groupId': 'OG001'}]}]}, {'title': 'AUCτ - Day 14', 'categories': [{'measurements': [{'value': '37.14', 'spread': '22.92', 'groupId': 'OG000'}, {'value': '30.97', 'spread': '24.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'Area under the plasma concentration curve (0-12 hours) of cortexolone 17α-propionate at baseline (i.e., Day 1, after first application \\[0-12 hours\\]) and at Day 14 (i.e., Day 14, after last application \\[0-12 hours\\]).', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'PK Profiles (Cavg) of Cortexolone 17α-propionate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cortexolone 17α-Propionate (Cohort 1)', 'description': 'Topical cream, 1.0% concentration, applied every twelve hours.'}, {'id': 'OG001', 'title': 'Cortexolone 17α-Propionate (Cohort 2)', 'description': 'Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.'}], 'classes': [{'title': 'Cavg - Day 1', 'categories': [{'measurements': [{'value': '1.84', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '1.88', 'groupId': 'OG001'}]}]}, {'title': 'Cavg - Day 14', 'categories': [{'measurements': [{'value': '3.10', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '2.58', 'spread': '2.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'Average concentration of cortexolone 17α-propionate in plasma calculated as the ratio of the AUC(0-12 hours) and the dosing interval (i.e., 12 hours) at baseline (i.e., Day 1, after first application) and at Day 14 (after last application).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cortexolone 17α-Propionate (Cohort 1)', 'description': 'Cohort 1 enrolled adult subjects. Topical cream, 1.0% concentration, applied every twelve hours.'}, {'id': 'FG001', 'title': 'Cortexolone 17α-Propionate (Cohort 2)', 'description': 'Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cortexolone 17α-Propionate (Cohort 1)', 'description': 'Topical cream, 1.0% concentration, applied every twelve hours.'}, {'id': 'BG001', 'title': 'Cortexolone 17α-Propionate (Cohort 2)', 'description': 'Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'spread': '5.84', 'groupId': 'BG000'}, {'value': '15.6', 'spread': '1.33', 'groupId': 'BG001'}, {'value': '19.8', 'spread': '6.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Forty-two (42) subjects were enrolled into the study across two cohorts dependent upon age:\n\nCohort 1: 20 adult subjects Cohort 2: 22 adolescent (12 to less than 18 years of age) subjects'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'See note above.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'See note above.'}, {'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'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'See note above.'}], 'populationDescription': 'Forty-two (42) subjects were enrolled into the study across two cohorts dependent upon age:\n\nCohort 1: 20 adult subjects Cohort 2: 22 adolescent (12 to less than 18 years of age) subjects'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'dispFirstSubmitDate': '2015-03-27', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2013-04-11', 'dispFirstSubmitQcDate': '2015-03-27', 'resultsFirstSubmitDate': '2020-09-23', 'studyFirstSubmitQcDate': '2013-04-11', 'dispFirstPostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-26', 'studyFirstPostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HPA Axis Response to Cosyntropin', 'timeFrame': 'Baseline and Day 14', 'description': 'Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin injection (Cosyntropin Stimulation Test - CST). Prior to CST, a pre-CST blood sample is taken between 7AM to 9AM. Thirty minutes after CST, a post-CST blood sample is collected. HPA axis suppression is defined as a post-stimulation serum cortisol level ≤ 18 μg/dL at Day 14.'}, {'measure': 'PK Profiles (Cmax) of Cortexolone 17α-propionate', 'timeFrame': 'Baseline and Day 14', 'description': 'Max concentration (Cmax) of cortexolone 17α-propionate in plasma following the first application (i.e., Day 1, 0-12 hours) and last application (i.e., Day 14, 0-12 hours).'}, {'measure': 'PK Profiles (AUC) of Cortexolone 17α-propionate', 'timeFrame': 'Baseline and Day 14', 'description': 'Area under the plasma concentration curve (0-12 hours) of cortexolone 17α-propionate at baseline (i.e., Day 1, after first application \\[0-12 hours\\]) and at Day 14 (i.e., Day 14, after last application \\[0-12 hours\\]).'}, {'measure': 'PK Profiles (Cavg) of Cortexolone 17α-propionate', 'timeFrame': 'Baseline and Day 14', 'description': 'Average concentration of cortexolone 17α-propionate in plasma calculated as the ratio of the AUC(0-12 hours) and the dosing interval (i.e., 12 hours) at baseline (i.e., Day 1, after first application) and at Day 14 (after last application).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cassiopea', 'clascoterone', 'cortexolone 17α-propionate', 'anti-androgen', 'CB-01-03'], 'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'This study is designed to determine the hypothalamic-pituitary-adrenal (HPA) axis suppression potential and pharmacokinetic (PK) properties of CB-03-01 Cream, 1%, applied every twelve hours for two weeks, in subjects with acne vulgaris ages 12 years or older.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has moderate to severe facial acne vulgaris as determined by the Investigator's Global Assessment (IGA) and obvious acne on the chest and/or back at study start.\n* Subject has facial acne vulgaris (including the nose) with a minimum number of inflammatory lesions (papules, pustules, and nodules/cysts) and a minimum number of non-inflammatory lesions (open and closed comedones) at study start.\n* Females must be post-menopausal, surgically sterile or using highly effective birth control methods with a negative urine pregnancy test (UPT) at study start.\n* Subject must be in general good health in the opinion of the investigator, with normal renal function, based on screening physical examination, medical history, and clinical laboratory values.\n\nExclusion Criteria:\n\n* Subject is pregnant, lactating, or is planning to become pregnant during the study.\n* Subject is 12-20 years of age and has a Body Mass Index (BMI) for age percentile \\> 85%.\n* Subject is \\> 20 years of age and has a BMI \\> 32.0 kg/m2.\n* Subject has used tobacco, smoking cessation products, or products containing nicotine within three months prior to study start.\n* Except for the use of contraceptives, subject has used any prescription drug or herbal product within 14 days prior to dosing, any non-prescription drug or vitamin or mineral supplements within 7 days prior to study start; any known enzyme-inducer, enzyme-inhibitor, or reported chronic exposure to enzyme-inducers such as paint solvents or pesticides within 30 days of study start.\n* Subject has used topical anti-acne medications containing retinoids such as tazarotene, adapalene or tretinoin, within four weeks of study start.\n* Subject has used the following systemic anti-acne medications: antibiotics within two weeks of study start, spironolactone within four weeks of study start, or retinoid therapy within three months of study start.\n* Subject has any skin or medical condition, including facial hair that could interfere with the evaluation of the test article or requires the use of interfering topical or systemic therapy.\n* Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the study.\n* Subject has used light treatments, microdermabrasion or chemical peels to the face, chest and back within eight weeks of study start.\n* Subject cannot avoid any type of strenuous exercise (swimming, running, team sports, etc.,) or the use of hot tubs/saunas from study start to the end of the study.\n* Subject has received an investigational drug or been treated with an investigational device within 30 days prior to study start.\n* Subject is currently enrolled in an investigational drug or device study.\n* Subject has used topical corticosteroids (including inhaled and intranasal corticosteroids) within two weeks of study start.\n* Subject has used systemic corticosteroids (including intramuscular and intralesional injections) within four weeks of study start.\n* Subject has an irregular sleep schedule or works night shifts.\n* Subject has experienced significant blood loss within 60 days or has donated plasma within 72 hours prior to study start.\n* Subject tests positive at Screening for human immunodeficiency virus (HIV) or is known to be seropositive for HIV.\n* Subject tests positive at Screening for hepatitis B surface antigen, hepatitis C antibody or has a history of a positive result.\n* Subject had major surgery within 30 days prior to study start or plans to have surgery during the study.\n* Subject has participated in a previous CB-03-01 study."}, 'identificationModule': {'nctId': 'NCT01831960', 'briefTitle': 'An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intrepid Therapeutics, Inc.'}, 'officialTitle': 'An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every Twelve Hours for Two Weeks in Subjects With Acne Vulgaris', 'orgStudyIdInfo': {'id': '171-7151-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cortexolone 17α-Propionate', 'description': 'Topical cream, 1.0% concentration, applied every twelve hours', 'interventionNames': ['Drug: cortexolone 17α-propionate']}], 'interventions': [{'name': 'cortexolone 17α-propionate', 'type': 'DRUG', 'otherNames': ['CB-03-01', 'clascoterone (USAN, INN)'], 'armGroupLabels': ['Cortexolone 17α-Propionate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Northwest Clinical Trials, Inc.', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Shideler Clinical Research Center', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'city': 'Clinton Township', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Center for Research Corp.', 'geoPoint': {'lat': 42.58698, 'lon': -82.91992}}], 'overallOfficials': [{'name': 'R&D Cassiopea', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cassiopea S.p.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intrepid Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}