Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-27 @ 2:00 PM
Study NCT ID:
NCT00881868
Status:
COMPLETED
Last Update Posted:
2022-08-25
First Post:
2009-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ron.gottschalk@galderma.com', 'phone': '817-961-5358', 'title': 'Ronald W. Gottschalk, MD / Medical Director', 'organization': 'Galderma Laboratories, L.P.'}, 'certainAgreement': {'otherDetails': 'The principal investigator has the right to publish or present the data resulting from this study, with agreed upon reviews by all interested parties, and in accordance with any confidentiality agreements that may exist.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'description': 'Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), if applicable.', 'eventGroups': [{'id': 'EG000', 'title': 'Clobex Spray', 'otherNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle Spray', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clobex Spray'}, {'id': 'OG001', 'title': 'Vehicle Spray'}], 'classes': [{'title': 'Scaling Baseline None (0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Scaling Week 4 None (0)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Scaling Baseline Mild (1)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Scaling Week 4 Mild (1)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Scaling Baseline Moderate (2)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Scaling Week 4 Moderate (2)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Scaling Baseline Severe (3)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Scaling Week 4 Severe (3)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Scaling Baseline Very Severe (4)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Scaling Week 4 Very Severe (4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema Baseline None (0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Erythema Week 4 None (0)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Erythema Baseline Mild (1)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Erythema Week 4 Mild (1)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Erythema Baseline Moderate (2)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Erythema Week 4 Moderate (2)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Erythema Baseline Severe (3)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Erythema Week 4 Severe (3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Erythema Baseline Very Severe (4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema Week 4 Very Severe (4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plaque Elevation Baseline None (0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plaque Elevation Week 4 None (0)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Plaque Elevation Baseline Mild (1)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Plaque Elevation Week 4 Mild (1)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Plaque Elevation Baseline Moderate (2)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Plaque Elevation Week 4 Moderate (2)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Plaque Elevation Baseline Severe (3)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Plaque Elevation Week 4 Severe (3)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Plaque Elevation Baseline Very Severe (4)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plaque Elevation Week 4 Very Severe (4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to week 4', 'description': 'Number of participants in each category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at baseline and end of treatment (week 4 or week 2 if GSS is Clear). Individual Sign Scores are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Very Severe) with 0 being best and 4 being worst.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clobex Spray'}, {'id': 'OG001', 'title': 'Vehicle Spray'}], 'classes': [{'title': 'Extent of Scalp Involvement Baseline None', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Extent of Scalp Involvement Week 4 None', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Extent of Scalp Involvement Baseline <20%', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Extent of Scalp Involvement Week 4 <20%', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Extent of Scalp Involvement Baseline 20-39%', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Extent of Scalp Involvement Week 4 20-39%', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Extent of Scalp Involvement Baseline 40-59%', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Extent of Scalp Involvement Week 4 40-59%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Extent of Scalp Involvement Baseline 60-79%', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Extent of Scalp Involvement Week 4 60-79%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Extent of Scalp Involvement Baseline 80-100%', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Extent of Scalp Involvement Week 4 80-100%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to week 4', 'description': 'Number of participants in each category of the Extent of Scalp Involvement Index at end of treatment (week 4 or week 2 if GSS was Clear). The Extent of Scalp Involvement Index is evaluated on a scale from 0 - 5 (0 = None, 2 = \\<20%, 2 = 20-39%, 3 = 40-59%, 4 = 60-79% and 5 = 80-100%) with 0 being best and 5 being worst.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants in Each Category of Pruritus at Baseline and Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clobex Spray'}, {'id': 'OG001', 'title': 'Vehicle Spray'}], 'classes': [{'title': 'Pruritus Baseline None (0)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus Week 4 None (0)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus Baseline Mild (1)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus Week 4 Mild (1)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus Baseline Moderate (2)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus Week 4 Moderate (2)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus Baseline Severe (3)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus Week 4 Severe (3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to week 4', 'description': 'Number of participants in each category of Pruritus at end of treatment (week 4 or week 2 if GSS was Clear). Pruritus is evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate and 3 = Severe) with 0 being best and 3 being worst.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clobex Spray'}, {'id': 'OG001', 'title': 'Vehicle Spray'}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to week 4', 'description': 'Number of participants who were a success or failure based on the Global Severity Score (GSS) of Scalp Psoriasis from baseline to end of treatment (Week 4 or Week 2 if Clear). GSS is evaluated on a scale from 0 - 5 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Very Severe) with 0 being best and 5 being worst. Success is defined as Clear or Almost Clear. (Note: 5 Clobex Spray subjects and 0 Vehicle Spray subjects were Clear at week 2 and their results were carried forward to week 4).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, LOCF'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clobex Spray'}, {'id': 'FG001', 'title': 'Vehicle Spray'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Dates of recruitment period: First subject was enrolled on April 20, 2009 and the last subject was enrolled on November 17, 2009.\n\nTypes of location: Investigative sites were located at private physician offices.', 'preAssignmentDetails': 'Wash-out period to baseline: 14 days: chemical hair process, steroid medication and/or ultraviolet B (UVB) treatment, calcipotriene, other vitamin D analogs, Anthralin/tar, all other anti-psoriasis medications; 4 wks: psoralen \\& UVA (PUVA) treatment \\& treatments other than biologics with possible efficacy on psoriasis; 12 wks: biological therapies'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Clobex Spray'}, {'id': 'BG001', 'title': 'Vehicle Spray'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.0', 'spread': '15.41', 'groupId': 'BG000'}, {'value': '41.3', 'spread': '13.72', 'groupId': 'BG001'}, {'value': '43.7', 'spread': '14.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2009-04-13', 'resultsFirstSubmitDate': '2010-12-16', 'studyFirstSubmitQcDate': '2009-04-14', 'lastUpdatePostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-12-16', 'studyFirstPostDateStruct': {'date': '2009-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear)', 'timeFrame': 'baseline to week 4', 'description': 'Number of participants who were a success or failure based on the Global Severity Score (GSS) of Scalp Psoriasis from baseline to end of treatment (Week 4 or Week 2 if Clear). GSS is evaluated on a scale from 0 - 5 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Very Severe) with 0 being best and 5 being worst. Success is defined as Clear or Almost Clear. (Note: 5 Clobex Spray subjects and 0 Vehicle Spray subjects were Clear at week 2 and their results were carried forward to week 4).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4', 'timeFrame': 'baseline to week 4', 'description': 'Number of participants in each category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at baseline and end of treatment (week 4 or week 2 if GSS is Clear). Individual Sign Scores are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Very Severe) with 0 being best and 4 being worst.'}, {'measure': 'Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4', 'timeFrame': 'baseline to week 4', 'description': 'Number of participants in each category of the Extent of Scalp Involvement Index at end of treatment (week 4 or week 2 if GSS was Clear). The Extent of Scalp Involvement Index is evaluated on a scale from 0 - 5 (0 = None, 2 = \\<20%, 2 = 20-39%, 3 = 40-59%, 4 = 60-79% and 5 = 80-100%) with 0 being best and 5 being worst.'}, {'measure': 'Number of Participants in Each Category of Pruritus at Baseline and Week 4', 'timeFrame': 'baseline to week 4', 'description': 'Number of participants in each category of Pruritus at end of treatment (week 4 or week 2 if GSS was Clear). Pruritus is evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate and 3 = Severe) with 0 being best and 3 being worst.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Scalp Psoriasis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety and efficacy of clobetasol propionate spray versus vehicle spray for the management of moderate to severe plaque psoriasis of the scalp.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with diagnosis of moderate to severe plaque psoriasis of the scalp\n\nExclusion Criteria:\n\n* Subjects who need systemic treatment for their body psoriasis\n* Subjects who have surface area involvement too large (\\>20% Body Surface Area \\[BSA\\]) that would require more than 50 grams per week of study product'}, 'identificationModule': {'nctId': 'NCT00881868', 'briefTitle': 'Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Clobetasol Propionate Spray Versus Vehicle for the Management of Moderate to Severe Plaque Psoriasis of the Scalp', 'orgStudyIdInfo': {'id': 'US10118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Clobex Spray', 'interventionNames': ['Drug: clobetasol propionate spray 0.05%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle spray', 'interventionNames': ['Drug: Vehicle spray']}], 'interventions': [{'name': 'clobetasol propionate spray 0.05%', 'type': 'DRUG', 'otherNames': ['Clobex® Spray 0.05%'], 'description': 'Apply enough product to cover affected areas topically twice daily at least 8 hours apart', 'armGroupLabels': ['Clobex Spray']}, {'name': 'Vehicle spray', 'type': 'DRUG', 'description': 'Apply enough product to cover affected areas topically twice daily at least 8 hours apart', 'armGroupLabels': ['Vehicle spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Research Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Hudson Dermatology', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '10155', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Division of The Skin Specialty Group', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Dermatology Associates, PLLC', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Ronald W Gottschalk, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galderma R&D'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}