Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-31 @ 12:31 PM
Study NCT ID:
NCT01231334
Status:
COMPLETED
Last Update Posted:
2012-07-27
First Post:
2010-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne
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': 'D003622', 'term': 'Dapsone'}, {'id': 'D000068816', 'term': 'Adapalene'}, {'id': 'D005782', 'term': 'Gels'}, {'id': 'D002981', 'term': 'Clindamycin'}, {'id': 'D001585', 'term': 'Benzoyl Peroxide'}], 'ancestors': [{'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Vice President Medical Affairs,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety population includes all participants who received study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Aczone® Gel 5% Plus Differin® 0.3% Gel', 'description': 'Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks', 'otherNumAtRisk': 136, 'otherNumAffected': 23, 'seriousNumAtRisk': 136, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Duac® Topical Gel Plus Differin® 0.3% Gel', 'description': 'Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.', 'otherNumAtRisk': 135, 'otherNumAffected': 15, 'seriousNumAtRisk': 135, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aczone® Gel 5% Plus Differin® 0.3% Gel', 'description': 'Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks'}, {'id': 'OG001', 'title': 'Duac® Topical Gel Plus Differin® 0.3% Gel', 'description': 'Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.80', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '2.84', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Week 12', 'categories': [{'measurements': [{'value': '-0.87', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '-1.27', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "GAAS was conducted by the investigator. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules and nodules are round, solid elevations of the skin with no visible fluid. A negative change from baseline indicates improvement.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aczone® Gel 5% Plus Differin® 0.3% Gel', 'description': 'Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks'}, {'id': 'OG001', 'title': 'Duac® Topical Gel Plus Differin® 0.3% Gel', 'description': 'Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.5', 'groupId': 'OG000'}, {'value': '92.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'The overall disease severity was evaluated by the investigator at Baseline and Week 12 using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. The percentage of participants with at least a one point decrease (improvement) from baseline is calculated.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Inflammatory Lesion Counts at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aczone® Gel 5% Plus Differin® 0.3% Gel', 'description': 'Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks'}, {'id': 'OG001', 'title': 'Duac® Topical Gel Plus Differin® 0.3% Gel', 'description': 'Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-70.7', 'groupId': 'OG000', 'lowerLimit': '-100.0', 'upperLimit': '38.1'}, {'value': '-75.9', 'groupId': 'OG001', 'lowerLimit': '-100.0', 'upperLimit': '-17.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Percent Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aczone® Gel 5% Plus Differin® 0.3% Gel', 'description': 'Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks'}, {'id': 'OG001', 'title': 'Duac® Topical Gel Plus Differin® 0.3% Gel', 'description': 'Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.3', 'groupId': 'OG000', 'lowerLimit': '-100.0', 'upperLimit': '115.0'}, {'value': '-60.7', 'groupId': 'OG001', 'lowerLimit': '-100.0', 'upperLimit': '31.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Percent Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or "pimples") lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement).', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Lesion Count at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aczone® Gel 5% Plus Differin® 0.3% Gel', 'description': 'Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks'}, {'id': 'OG001', 'title': 'Duac® Topical Gel Plus Differin® 0.3% Gel', 'description': 'Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-62.7', 'spread': '27.0', 'groupId': 'OG000', 'lowerLimit': '-98.0', 'upperLimit': '75.6'}, {'value': '-65.0', 'spread': '22.5', 'groupId': 'OG001', 'lowerLimit': '-100.0', 'upperLimit': '8.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Percent change in total lesion counts: inflammatory (papules, pustules and nodules) and non-inflammatory (comedones) lesion counts from baseline. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters ) and nodules are larger (greater than 5 or 10 millimeters). Pustules are small elevations of the skin containing cloudy material. Comedones are small bumps on the skin caused by acne and found at the opening of a skin pore. A negative change from baseline indicates a reduction in lesion counts (improvement).', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aczone® Gel 5% Plus Differin® 0.3% Gel', 'description': 'Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks'}, {'id': 'OG001', 'title': 'Duac® Topical Gel Plus Differin® 0.3% Gel', 'description': 'Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.'}], 'classes': [{'title': 'Dryness', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'Peeling', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'Oiliness', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus', 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'Burning', 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000'}, {'value': '12.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': "The investigator rated the patient's current symptoms of erythema, dryness, peeling, and oiliness on a 5 point scale from 0 (Absent) to 4 (Severe). The investigator rated the symptoms of pruritus and burning since last visit on a 6 point scale of 0 (Absent) to 5 (Severe)-interfering with daily activities. Percentage of participants demonstrating a ≥1 category increase (improvement) in tolerability from baseline is calculated.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aczone® Gel 5% Plus Differin® 0.3% Gel', 'description': 'Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks'}, {'id': 'OG001', 'title': 'Duac® Topical Gel Plus Differin® 0.3% Gel', 'description': 'Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.7', 'groupId': 'OG000'}, {'value': '81.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': "GAAS was conducted by the investigator at Baseline and Week 12. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules/nodules are round, solid elevations of the skin with no visible fluid. The percentage of participants with at least a one point decrease (improvement) in GAAS was calculated.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aczone® Gel 5% Plus Differin® 0.3% Gel', 'description': 'Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks'}, {'id': 'FG001', 'title': 'Duac® Topical Gel Plus Differin® 0.3% Gel', 'description': 'Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '141'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '21'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aczone® Gel 5% Plus Differin® 0.3% Gel', 'description': 'Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks'}, {'id': 'BG001', 'title': 'Duac® Topical Gel Plus Differin® 0.3% Gel', 'description': 'Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '27.9', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '27.6', 'spread': '6.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 286}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-25', 'studyFirstSubmitDate': '2010-10-28', 'resultsFirstSubmitDate': '2012-06-25', 'studyFirstSubmitQcDate': '2010-10-29', 'lastUpdatePostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-25', 'studyFirstPostDateStruct': {'date': '2010-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': "GAAS was conducted by the investigator at Baseline and Week 12. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules/nodules are round, solid elevations of the skin with no visible fluid. The percentage of participants with at least a one point decrease (improvement) in GAAS was calculated."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': "GAAS was conducted by the investigator. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules and nodules are round, solid elevations of the skin with no visible fluid. A negative change from baseline indicates improvement."}, {'measure': 'Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity', 'timeFrame': 'Baseline, Week 12', 'description': 'The overall disease severity was evaluated by the investigator at Baseline and Week 12 using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. The percentage of participants with at least a one point decrease (improvement) from baseline is calculated.'}, {'measure': 'Percent Change From Baseline in Inflammatory Lesion Counts at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Percent Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).'}, {'measure': 'Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Percent Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or "pimples") lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement).'}, {'measure': 'Percent Change From Baseline in Total Lesion Count at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Percent change in total lesion counts: inflammatory (papules, pustules and nodules) and non-inflammatory (comedones) lesion counts from baseline. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters ) and nodules are larger (greater than 5 or 10 millimeters). Pustules are small elevations of the skin containing cloudy material. Comedones are small bumps on the skin caused by acne and found at the opening of a skin pore. A negative change from baseline indicates a reduction in lesion counts (improvement).'}, {'measure': 'Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': "The investigator rated the patient's current symptoms of erythema, dryness, peeling, and oiliness on a 5 point scale from 0 (Absent) to 4 (Severe). The investigator rated the symptoms of pruritus and burning since last visit on a 6 point scale of 0 (Absent) to 5 (Severe)-interfering with daily activities. Percentage of participants demonstrating a ≥1 category increase (improvement) in tolerability from baseline is calculated."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'A study comparing the topical application of Aczone® plus Differin® versus Duac® plus Differin® in patients with severe facial acne (facial acne vulgaris).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe facial acne (acne vulgaris)\n\nExclusion Criteria:\n\n* History of significant anemia or hemolysis\n* History of enteritis (eg, regional enteritis, ulcerative colitis, pseudomembranous colitis, antibiotic-associated colitis)\n* History of lupus, rosacea, or seborrheic dermatitis'}, 'identificationModule': {'nctId': 'NCT01231334', 'briefTitle': 'A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'MA-ACZ1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aczone® Gel 5% plus Differin® 0.3% Gel', 'description': 'Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks.', 'interventionNames': ['Drug: Dapsone plus Adapalene']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Duac® Topical Gel plus Differin® 0.3% Gel', 'description': 'Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.', 'interventionNames': ['Drug: Clindamycin/benzoyl peroxide plus Adapalene']}], 'interventions': [{'name': 'Dapsone plus Adapalene', 'type': 'DRUG', 'otherNames': ['Aczone® Gel 5%', 'Differin® 0.3% Gel'], 'description': 'Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks.', 'armGroupLabels': ['Aczone® Gel 5% plus Differin® 0.3% Gel']}, {'name': 'Clindamycin/benzoyl peroxide plus Adapalene', 'type': 'DRUG', 'otherNames': ['Duac® Topical Gel', 'Differin® 0.3% Gel'], 'description': 'Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks', 'armGroupLabels': ['Duac® Topical Gel plus Differin® 0.3% Gel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}