Viewing Study NCT00852761

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Ignite Creation Date: 2025-12-24 @ 12:38 PM
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Study NCT ID: NCT00852761
Status: COMPLETED
Last Update Posted: 2012-04-23
First Post: 2009-02-25
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002990', 'term': 'Clobetasol'}], 'ancestors': [{'id': 'D001623', 'term': 'Betamethasone'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline through Day 15.', 'eventGroups': [{'id': 'EG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.', 'otherNumAtRisk': 17, 'otherNumAffected': 2, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 11.1'}, {'term': 'Hpertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to day 15', 'description': 'Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'At Least 1 Grade Improvement Psoriasis Grading Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7298', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This is the result for the Day 3 analysis.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This is the result for the Day 8 analysis.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, days 3 and 8', 'description': 'Number of participants who achieve a minimum one grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.\n\nThe scale is the same as used for the primary outcome (0 through 5).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT)'}, {'type': 'SECONDARY', 'title': 'At Least a 2 Grade Improvement Psoriasis Grading Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7298', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This is the result for the Day 3 analysis.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0060', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This is the result for the Day 8 analysis.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0060', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This is the result for the Day 15 analysis.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, days 3, 8, 15', 'description': 'Number of participants who achieve a minimum two grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.\n\nThe scale is the same as used for the primary outcome (0 through 5).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT)'}, {'type': 'SECONDARY', 'title': 'At Least a 3 Grade Improvement Psoriasis Grading Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0332', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Data apply to Day 15.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, days 3, 8, 15', 'description': 'Number of participants who achieve a minimum of three grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.\n\nThe scale is the same as used for the primary outcome (0 through 5).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT)'}, {'type': 'SECONDARY', 'title': 'At Least 1 Grade Improvement in the Psoriasis Global Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, days 3, 8, 15', 'description': 'Number of participants who acheive at least a 1 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT)'}, {'type': 'SECONDARY', 'title': 'At Least a 2 Grade Improvement in the Psoriasis Global Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3101', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This is the result for the Day 3 analysis.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7242', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This is the result for the Day 8 analysis.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0135', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This is the p value for day 15', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, days 3, 8, 15', 'description': 'Number of participants who acheive at least a 2 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT)'}, {'type': 'SECONDARY', 'title': 'At Least a 3 Grade Improvement in the Psoriasis Global Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, days 3, 8, 15', 'description': 'Number of participants who acheive at least a 3 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT)'}, {'type': 'SECONDARY', 'title': "At Least 1 Grade Improvement in Subject's Global Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1449', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value at day 15.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1634', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value at day 3.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5454', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value at day 8.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, days 3, 8, 15', 'description': "Number of participants who achieve treatment success (minimum one grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT)'}, {'type': 'SECONDARY', 'title': "At Least a 2 Grade Improvement in Subject's Global Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6715', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This is the p value for day 15.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7242', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This is the p value for day 8.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6715', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This is the p value for day 3.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, days 3, 8, 15', 'description': "Number of participants who achieve treatment success (minimum two grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT)'}, {'type': 'SECONDARY', 'title': "At Least a 3 Grade Improvement in Subject's Global Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4858', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value on day 8.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value on day 15.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, days 3, 8, 15', 'description': "Number of participants who achieve treatment success (minimum three grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT)'}, {'type': 'SECONDARY', 'title': 'Median Change in Psoriasis Grading Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '0'}, {'value': '-1', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '0'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-1'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '-1'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-1'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '-2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Days 3, 8, 15', 'description': 'Median improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.', 'unitOfMeasure': 'unites on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Dermatology Quality of Life - Symptoms and Feelings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3, n=16, 17', 'categories': [{'measurements': [{'value': '1.94', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '1.70', 'groupId': 'OG001'}]}]}, {'title': 'Day 8, n=17, 17', 'categories': [{'measurements': [{'value': '1.06', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, n=17, 17', 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 3, 8, 15', 'description': 'Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.\n\nSum of scores for questions 1 and 2. Score range from 0 to 6. A higher score denotes a more impaired quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)'}, {'type': 'SECONDARY', 'title': 'Dermatology Quality of Life - Daily Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3, n=16, 17', 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '1.23', 'groupId': 'OG001'}]}]}, {'title': 'Day 8, n=17, 17', 'categories': [{'measurements': [{'value': '0.53', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, n=17, 17', 'categories': [{'measurements': [{'value': '0.53', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '1.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 3, 8, 15', 'description': 'Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.\n\nSum of scores for questions 3 and 4. Score range from 0 to 6. A higher score denotes a more impaired quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)'}, {'type': 'SECONDARY', 'title': 'Dermatology Quality of Life - Leisure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3, n=16, 17', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '1.30', 'groupId': 'OG001'}]}]}, {'title': 'Day 8, n=17, 17', 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, n=17, 17', 'categories': [{'measurements': [{'value': '0.35', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 3, 8, 15', 'description': 'Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.\n\nSum of scores for questions 5 and 6. Score range from 0 to 6. A higher score denotes a more impaired quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)'}, {'type': 'SECONDARY', 'title': 'Dermatology Quality of Life - Work and School', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3, n=15, 17', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Day 8, n=16, 17', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, n=17, 17', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 3, 8, 15', 'description': 'Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.\n\nSum of scores for questions 7. Score range from 0 to 3. A higher score denotes a more impaired quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)'}, {'type': 'SECONDARY', 'title': 'Dermatology Quality of Life - Personal Relationships', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3, n=15, 17', 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Day 8, n=16, 17', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, n=17, 17', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 3, 8, 15', 'description': 'Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.\n\nSum of scores for questions 8 and 9. Score range from 0 to 6. A higher score denotes a more impaired quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)'}, {'type': 'SECONDARY', 'title': 'Dermatology Quality of Life - Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3, n=16, 17', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 8, n=17, 17', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, n=17, 17', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 3, 8, 15', 'description': 'Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.\n\nSum of scores for question 10. Score range from 0 to 3. A higher score denotes a more impaired quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)'}, {'type': 'SECONDARY', 'title': 'Total Dermatology Life Quality Index (DLQI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '3.75', 'spread': '2.82', 'groupId': 'OG000'}, {'value': '5.76', 'spread': '4.64', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '2.65', 'spread': '3.44', 'groupId': 'OG000'}, {'value': '3.29', 'spread': '3.64', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '2.12', 'spread': '3.64', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '3.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 3, 8, 15', 'description': 'Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.\n\nSum of scores for all questions. Score range from 0 to 30. A higher score denotes a more impaired quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)'}, {'type': 'SECONDARY', 'title': 'Dermatology Life Quality Index (DLQI) Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam'}, {'id': 'OG001', 'title': 'Clobex Lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.'}], 'classes': [{'title': 'Day 3 Score 0 -1 No effect', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Day 3 Score 2- 5 Small effect', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Day 3 Score 6- 10 Moderate effect', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Day 3 Score 11- 20 Very large effect', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 Score 0 -1 No effect', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 Score 2- 5 Small effect', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 Score 6- 10 Moderate effect', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 Score 11- 20 Very large effect', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 Score 0 -1 No effect', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 Score 2- 5 Small effect', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 Score 6- 10 Moderate effect', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 Score 11- 20 Very large effect', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 3, 8, 15', 'description': "Number of participants who indicated one of the following for total DLQI: 0-1 No effect on the patient's life; 2-5 Small effect on the patient's life; 6-10 Moderate effect on the patient's life; 11-20 Very large effect on the patient's life.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.'}, {'id': 'FG001', 'title': 'Clobex Lotion', 'description': 'Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Clinical research center'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Olux-E Foam', 'description': 'Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.'}, {'id': 'BG001', 'title': 'Clobex Lotion', 'description': 'Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '48.2', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '48.6', 'spread': '13', 'groupId': 'BG001'}, {'value': '48.4', 'spread': '12.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '30.0', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '30.6', 'spread': '7.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women and is measured in kg/m\\^2.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-19', 'studyFirstSubmitDate': '2009-02-25', 'resultsFirstSubmitDate': '2010-11-04', 'studyFirstSubmitQcDate': '2009-02-26', 'lastUpdatePostDateStruct': {'date': '2012-04-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-01', 'studyFirstPostDateStruct': {'date': '2009-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)', 'timeFrame': 'Baseline to day 15', 'description': 'Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.'}], 'secondaryOutcomes': [{'measure': 'At Least 1 Grade Improvement Psoriasis Grading Scale', 'timeFrame': 'Baseline, days 3 and 8', 'description': 'Number of participants who achieve a minimum one grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.\n\nThe scale is the same as used for the primary outcome (0 through 5).'}, {'measure': 'At Least a 2 Grade Improvement Psoriasis Grading Scale', 'timeFrame': 'Baseline, days 3, 8, 15', 'description': 'Number of participants who achieve a minimum two grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.\n\nThe scale is the same as used for the primary outcome (0 through 5).'}, {'measure': 'At Least a 3 Grade Improvement Psoriasis Grading Scale', 'timeFrame': 'Baseline, days 3, 8, 15', 'description': 'Number of participants who achieve a minimum of three grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.\n\nThe scale is the same as used for the primary outcome (0 through 5).'}, {'measure': 'At Least 1 Grade Improvement in the Psoriasis Global Assessment', 'timeFrame': 'Baseline, days 3, 8, 15', 'description': 'Number of participants who acheive at least a 1 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.'}, {'measure': 'At Least a 2 Grade Improvement in the Psoriasis Global Assessment', 'timeFrame': 'Baseline, days 3, 8, 15', 'description': 'Number of participants who acheive at least a 2 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.'}, {'measure': 'At Least a 3 Grade Improvement in the Psoriasis Global Assessment', 'timeFrame': 'Baseline, days 3, 8, 15', 'description': 'Number of participants who acheive at least a 3 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.'}, {'measure': "At Least 1 Grade Improvement in Subject's Global Assessment", 'timeFrame': 'Baseline, days 3, 8, 15', 'description': "Number of participants who achieve treatment success (minimum one grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques."}, {'measure': "At Least a 2 Grade Improvement in Subject's Global Assessment", 'timeFrame': 'Baseline, days 3, 8, 15', 'description': "Number of participants who achieve treatment success (minimum two grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques."}, {'measure': "At Least a 3 Grade Improvement in Subject's Global Assessment", 'timeFrame': 'Baseline, days 3, 8, 15', 'description': "Number of participants who achieve treatment success (minimum three grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques."}, {'measure': 'Median Change in Psoriasis Grading Scale', 'timeFrame': 'Baseline, Days 3, 8, 15', 'description': 'Median improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.'}, {'measure': 'Dermatology Quality of Life - Symptoms and Feelings', 'timeFrame': 'Baseline, Days 3, 8, 15', 'description': 'Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.\n\nSum of scores for questions 1 and 2. Score range from 0 to 6. A higher score denotes a more impaired quality of life'}, {'measure': 'Dermatology Quality of Life - Daily Activities', 'timeFrame': 'Baseline, Days 3, 8, 15', 'description': 'Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.\n\nSum of scores for questions 3 and 4. Score range from 0 to 6. A higher score denotes a more impaired quality of life'}, {'measure': 'Dermatology Quality of Life - Leisure', 'timeFrame': 'Baseline, Days 3, 8, 15', 'description': 'Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.\n\nSum of scores for questions 5 and 6. Score range from 0 to 6. A higher score denotes a more impaired quality of life'}, {'measure': 'Dermatology Quality of Life - Work and School', 'timeFrame': 'Baseline, Days 3, 8, 15', 'description': 'Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.\n\nSum of scores for questions 7. Score range from 0 to 3. A higher score denotes a more impaired quality of life'}, {'measure': 'Dermatology Quality of Life - Personal Relationships', 'timeFrame': 'Baseline, Days 3, 8, 15', 'description': 'Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.\n\nSum of scores for questions 8 and 9. Score range from 0 to 6. A higher score denotes a more impaired quality of life'}, {'measure': 'Dermatology Quality of Life - Treatment', 'timeFrame': 'Baseline, Days 3, 8, 15', 'description': 'Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.\n\nSum of scores for question 10. Score range from 0 to 3. A higher score denotes a more impaired quality of life'}, {'measure': 'Total Dermatology Life Quality Index (DLQI) Score', 'timeFrame': 'Baseline, Days 3, 8, 15', 'description': 'Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.\n\nSum of scores for all questions. Score range from 0 to 30. A higher score denotes a more impaired quality of life'}, {'measure': 'Dermatology Life Quality Index (DLQI) Categories', 'timeFrame': 'Days 3, 8, 15', 'description': "Number of participants who indicated one of the following for total DLQI: 0-1 No effect on the patient's life; 2-5 Small effect on the patient's life; 6-10 Moderate effect on the patient's life; 11-20 Very large effect on the patient's life."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psoriasis'], 'conditions': ['Plaque-Type Psoriasis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.', 'detailedDescription': 'This study is being conducted to obtain efficacy and tolerability data for two clobetasol propionate therapies in the treatment of plaque-type psoriasis. Subjects will be randomized to only one of the two therapies for treatment throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body surface area (BSA) affected with psoriasis between 4% and 20% .\n* Target lesion of at least 2 cm² on the elbow and/or knee, with a score of 2 or 3 on the Psoriasis Grading Scale for Target Lesion.\n* Elbow and/or knee plaque-type psoriasis with a Psoriasis Global Assessment of mild or moderate (2 or 3).\n* Definitive diagnosis of elbow and/or knee plaque-type psoriasis.\n* Capable of understanding and willing to provide a signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed.\n* Male or female, 18 years of age or older at the time that the consent form was signed.\n* Able to complete the study and comply with study instructions.\n* Female subjects of childbearing potential must have had a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception.\n\nExclusion Criteria:\n\n* Use of any emollient applied to psoriasis plaques treated with the study medication during the study.\n* Other serious skin disorder or any chronic medical condition that is not well controlled.\n* Female subjects who are pregnant, trying to become pregnant or lactating.\n* Any major illness within 30 days prior to the baseline visit.\n* Received any investigational drug or treatment within 30 days of the baseline visit or who are scheduled to receive an investigational drug or treatment other than the study products during the study.'}, 'identificationModule': {'nctId': 'NCT00852761', 'briefTitle': 'A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Study to Evaluate Safety and Efficacy of Clobetasol Propionate for Treatment of Plaque-Type Psoriasis in Adult Subjects.', 'orgStudyIdInfo': {'id': '114569'}, 'secondaryIdInfos': [{'id': 'U0280-402'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olux-E Foam', 'description': 'Olux-E (clobetasol propionate 0.05%) foam', 'interventionNames': ['Drug: Olux-E Foam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clobex lotion', 'description': 'Clobex (clobetasol propionate 0.05%) lotion.', 'interventionNames': ['Drug: Clobex lotion']}], 'interventions': [{'name': 'Olux-E Foam', 'type': 'DRUG', 'description': 'Olux-E (clobetasol propionate 0.05%) foam. Starting at baseline, subjects were to apply twice daily Olux-E foam to the affected elbows and/or knees up to day 15.', 'armGroupLabels': ['Olux-E Foam']}, {'name': 'Clobex lotion', 'type': 'DRUG', 'otherNames': ['clobetasol lotion', 'Clobex'], 'description': 'Clobetasol propionate 0.05% lotion. Starting at baseline, subjects were to apply twice daily Clobex lotion to the affected elbows and/or knees up to day 15', 'armGroupLabels': ['Clobex lotion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences Department of Dermatology', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stiefel, a GSK Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}