Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2026-01-04 @ 8:33 AM
Study NCT ID:
NCT00678561
Status:
COMPLETED
Last Update Posted:
2020-12-31
First Post:
2008-05-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Topical CP-690,550 For Chronic Plaque Psoriasis
Sponsor:
Organization:
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': 'C479163', 'term': 'tofacitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': '2% CP-690,550 Once Daily', 'description': 'CP-690,550 2.0 percent (%) (50 microgram per square centimeter \\[mcg/cm\\^2\\]) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '0.2% CP-690,550 Once Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '0.02% CP-690,550 Once Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active), applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.', 'otherNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo Once Daily', 'description': 'CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas, once daily up to Day 28.', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '2% CP-690,550 Twice Daily', 'description': 'CP-690,550 2.0% (50 mcg/cm\\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.', 'otherNumAtRisk': 17, 'otherNumAffected': 6, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '0.2% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.', 'otherNumAtRisk': 17, 'otherNumAffected': 11, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '0.02% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.', 'otherNumAtRisk': 15, 'otherNumAffected': 7, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Placebo Twice Daily', 'description': 'CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas twice daily up to Day 28.', 'otherNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Application site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Cardiac murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Adjustment disorder with depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '2% CP-690,550 Once Daily', 'description': 'CP-690,550 2.0 percent (%) (50 microgram per square centimeter \\[mcg/cm\\^2\\]) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'OG001', 'title': '0.2% CP-690,550 Once Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'OG002', 'title': '0.02% CP-690,550 Once Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active), applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'OG003', 'title': 'Placebo Once Daily', 'description': 'CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas once daily up to Day 28.'}, {'id': 'OG004', 'title': '2% CP-690,550 Twice Daily', 'description': 'CP-690,550 2.0% (50 mcg/cm\\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG005', 'title': '0.2% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2) gel applied topically on 1 target plaque area, along with matching placebo gel on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG006', 'title': '0.02% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG007', 'title': 'Placebo Twice Daily', 'description': 'Matching placebo gel applied topically on 2 target plaque areas twice daily up to Day 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.38', 'spread': '5.83', 'groupId': 'OG000'}, {'value': '-4.76', 'spread': '11.66', 'groupId': 'OG001'}, {'value': '2.48', 'spread': '11.50', 'groupId': 'OG002'}, {'value': '-4.17', 'spread': '8.33', 'groupId': 'OG003'}, {'value': '-4.46', 'spread': '9.23', 'groupId': 'OG004'}, {'value': '-1.77', 'spread': '20.87', 'groupId': 'OG005'}, {'value': '-3.29', 'spread': '21.34', 'groupId': 'OG006'}, {'value': '-7.14', 'spread': '20.11', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point severity scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication and had a valid baseline with at least one valid post-baseline value for efficacy parameter. N (number of participants analyzed) is signifying those participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions", 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '2% CP-690,550 Once Daily', 'description': 'CP-690,550 2.0 percent (%) (50 microgram per square centimeter \\[mcg/cm\\^2\\]) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'OG001', 'title': '0.2% CP-690,550 Once Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'OG002', 'title': '0.02% CP-690,550 Once Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active), applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'OG003', 'title': 'Placebo Once Daily', 'description': 'CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas, once daily up to Day 28.'}, {'id': 'OG004', 'title': '2% CP-690,550 Twice Daily', 'description': 'CP-690,550 2.0% (50 mcg/cm\\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG005', 'title': '0.2% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG006', 'title': '0.02% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG007', 'title': 'Placebo Twice Daily', 'description': 'CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas twice daily up to Day 28.'}], 'classes': [{'title': 'Active, Clear', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '6.7', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}]}]}, {'title': 'Active, Almost Clear', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '13.3', 'groupId': 'OG004'}, {'value': '25.0', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}, {'value': '14.3', 'groupId': 'OG007'}]}]}, {'title': 'Vehicle, Clear', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}]}]}, {'title': 'Vehicle, Almost Clear', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '26.7', 'groupId': 'OG004'}, {'value': '25.0', 'groupId': 'OG005'}, {'value': '13.3', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'PGA of Psoriasis: The investigator scored each target lesion on a 5-point scale, reflecting the erythema, induration and scaling separately for each target lesions. Each parameter was scored from 0 to 4, with appropriate morphologic descriptors. The 5-point scale for PGA was: 0, "clear"; 1, "almost clear"; 2, "mild"; 3, "moderate"; 4 "severe". The sum of the 3 scores was divided by 3 to obtain a final PGA score. Total score range: 0 to 4, higher score indicated greater severity of disease. Success was considered as PGA response of "clear" and "almost clear".', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included participants who received at least 1 dose of study medication and had a valid baseline with at least one valid post-baseline value for efficacy assessment. N (number of participants analyzed) is signifying those participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '2% CP-690,550 Once Daily', 'description': 'CP-690,550 2.0 percent (%) (50 microgram per square centimeter \\[mcg/cm\\^2\\]) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'OG001', 'title': '0.2% CP-690,550 Once Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'OG002', 'title': '0.02% CP-690,550 Once Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active), applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'OG003', 'title': 'Placebo Once Daily', 'description': 'CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas, once daily up to Day 28.'}, {'id': 'OG004', 'title': '2% CP-690,550 Twice Daily', 'description': 'CP-690,550 2.0% (50 mcg/cm\\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG005', 'title': '0.2% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG006', 'title': '0.02% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG007', 'title': 'Placebo Twice Daily', 'description': 'CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas twice daily up to Day 28.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '5.56', 'spread': '13.61', 'groupId': 'OG001'}, {'value': '-1.39', 'spread': '9.74', 'groupId': 'OG002'}, {'value': '-16.67', 'spread': '33.33', 'groupId': 'OG003'}, {'value': '-1.59', 'spread': '28.97', 'groupId': 'OG004'}, {'value': '4.24', 'spread': '16.30', 'groupId': 'OG005'}, {'value': '2.13', 'spread': '11.59', 'groupId': 'OG006'}, {'value': '-3.87', 'spread': '7.19', 'groupId': 'OG007'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-5.56', 'spread': '8.61', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '8.90', 'groupId': 'OG001'}, {'value': '0.69', 'spread': '8.63', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '-3.49', 'spread': '16.24', 'groupId': 'OG004'}, {'value': '0.25', 'spread': '9.82', 'groupId': 'OG005'}, {'value': '-4.55', 'spread': '16.11', 'groupId': 'OG006'}, {'value': '-4.42', 'spread': '13.45', 'groupId': 'OG007'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '2.78', 'spread': '6.80', 'groupId': 'OG001'}, {'value': '8.73', 'spread': '13.52', 'groupId': 'OG002'}, {'value': '-16.67', 'spread': '28.87', 'groupId': 'OG003'}, {'value': '-4.66', 'spread': '13.47', 'groupId': 'OG004'}, {'value': '3.06', 'spread': '22.74', 'groupId': 'OG005'}, {'value': '-2.99', 'spread': '16.38', 'groupId': 'OG006'}, {'value': '-2.83', 'spread': '16.00', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 3', 'description': 'TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS: all randomized participants who received at least 1 dose of study medication; had a valid baseline with at least 1 valid post-baseline efficacy assessment. Here 'N' (number of participants analyzed)= participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Administration Site Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '2% CP-690,550 Once Daily', 'description': 'CP-690,550 2.0 percent (%) (50 microgram per square centimeter \\[mcg/cm\\^2\\]) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'OG001', 'title': '0.2% CP-690,550 Once Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'OG002', 'title': '0.02% CP-690,550 Once Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active), applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'OG003', 'title': 'Placebo Once Daily', 'description': 'CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas, once daily up to Day 28.'}, {'id': 'OG004', 'title': '2% CP-690,550 Twice Daily', 'description': 'CP-690,550 2.0% (50 mcg/cm\\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG005', 'title': '0.2% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG006', 'title': '0.02% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG007', 'title': 'Placebo Twice Daily', 'description': 'CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas twice daily up to Day 28.'}], 'classes': [{'title': 'Active', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Vehicle', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days)', 'description': 'An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug. Administration site adverse event included documentation of any clinically significant local reaction, such as erosion, vesicles or scabbing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included participants who received at least 1 dose of study medication and had a valid baseline with at least one valid post-baseline value for efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Drug Plasma Concentrations of CP-690,555', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2% CP-690,550 Twice Daily', 'description': 'CP-690,550 2.0% (50 mcg/cm\\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG001', 'title': '0.2% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG002', 'title': '0.02% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}], 'classes': [{'title': '0 hour post-dose', 'categories': [{'measurements': [{'value': '0.183', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '0.116', 'spread': '0.020', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Mean and standard deviation were not estimable as data was below LOQ.', 'groupId': 'OG002'}]}]}, {'title': '1 hour post-dose', 'categories': [{'measurements': [{'value': '0.174', 'spread': '0.046', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Mean and standard deviation were not estimable as data was below LOQ.', 'groupId': 'OG001'}, {'value': '0.126', 'spread': 'NA', 'comment': 'Standard deviation not calculated as only 1 participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': '2 hour post-dose', 'categories': [{'measurements': [{'value': '0.191', 'spread': '0.059', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Mean and standard deviation were not estimable as data was below LOQ.', 'groupId': 'OG001'}, {'value': '0.115', 'spread': 'NA', 'comment': 'Standard deviation not calculated as only 1 participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': '9 hour post-dose', 'categories': [{'measurements': [{'value': '0.160', 'spread': '0.039', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Mean and standard deviation were not estimable as data was below LOQ.', 'groupId': 'OG001'}, {'value': '0.102', 'spread': 'NA', 'comment': 'Standard deviation not calculated as only 1 participant was evaluable.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28', 'description': 'Concentrations below the limit of quantification (LOQ) were not estimable. The LOQ was 0.1 ng/mL.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication; had a valid baseline with at least 1 valid post-baseline efficacy assessment of CP-690,550. Participants of reporting groups 2%, 0.2% and 0.02% CP-690,550 Once Daily regimen had no post-baseline measurable concentration of CP-690,550. "Overall number of participants analyzed" = who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Skin Biopsy Drug Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '2% CP-690,550 Once Daily', 'description': 'CP-690,550 2.0 percent (%) (50 microgram per square centimeter \\[mcg/cm\\^2\\]) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'OG001', 'title': '0.2% CP-690,550 Once Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'OG002', 'title': '0.02% CP-690,550 Once Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active), applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'OG003', 'title': 'Placebo Once Daily', 'description': 'CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas, once daily up to Day 28.'}, {'id': 'OG004', 'title': '2% CP-690,550 Twice Daily', 'description': 'CP-690,550 2.0% (50 mcg/cm\\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG005', 'title': '0.2% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG006', 'title': '0.02% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'OG007', 'title': 'Placebo Twice Daily', 'description': 'CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas twice daily up to Day 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4145', 'spread': '2.9877', 'groupId': 'OG000'}, {'value': '2.2320', 'spread': '2.7257', 'groupId': 'OG001'}, {'value': '0.3242', 'spread': '0.6343', 'groupId': 'OG002'}, {'value': '0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable as only 1 participant was evaluable', 'groupId': 'OG003'}, {'value': '8.2810', 'spread': '10.270', 'groupId': 'OG004'}, {'value': '0.2957', 'spread': '0.3675', 'groupId': 'OG005'}, {'value': '0.0847', 'spread': '0.1252', 'groupId': 'OG006'}, {'value': '0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable as only 2 participants were evaluable.', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'Skin biopsy drug concentrations was measured via drug levels in dermis and expressed as nanogram of drug per milligram (mg) of dermis weight. Tissue concentration (ng/mg) = (ng drug/mL extraction solvent multiplied by mL extraction solvent) divided by mg tissue weight; 1 mL of extraction solvent was used.', 'unitOfMeasure': 'ng/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included participants who received at least 1 dose of study medication and had a valid baseline with at least one valid post-baseline value for efficacy assessment. Overall number of participants analyzed = participants who were evaluable for this measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2% CP-690,550 Once Daily', 'description': 'CP-690,550 2.0 percent (%) (50 microgram per square centimeter \\[mcg/cm\\^2\\]) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'FG001', 'title': '0.2% CP-690,550 Once Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'FG002', 'title': '0.02% CP-690,550 Once Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active), applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'FG003', 'title': 'Placebo Once Daily', 'description': 'CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas, once daily up to Day 28.'}, {'id': 'FG004', 'title': '2% CP-690,550 Twice Daily', 'description': 'CP-690,550 2.0% (50 mcg/cm\\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'FG005', 'title': '0.2% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'FG006', 'title': '0.02% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'FG007', 'title': 'Placebo Twice Daily', 'description': 'CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas twice daily up to Day 28.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '17'}, {'groupId': 'FG006', 'numSubjects': '15'}, {'groupId': 'FG007', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '16'}, {'groupId': 'FG006', 'numSubjects': '15'}, {'groupId': 'FG007', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'During the study, enrollment into the 4 once daily dosing regimen treatment groups was discontinued in order to decrease the overall total number of participants to be enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '81', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': '2% CP-690,550 Once Daily', 'description': 'CP-690,550 2.0 percent (%) (50 microgram per square centimeter \\[mcg/cm\\^2\\]) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'BG001', 'title': '0.2% CP-690,550 Once Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'BG002', 'title': '0.02% CP-690,550 Once Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active), applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28.'}, {'id': 'BG003', 'title': 'Placebo Once Daily', 'description': 'CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas, once daily up to Day 28.'}, {'id': 'BG004', 'title': '2% CP-690,550 Twice Daily', 'description': 'CP-690,550 2.0% (50 mcg/cm\\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'BG005', 'title': '0.2% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.2% (5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'BG006', 'title': '0.02% CP-690,550 Twice Daily', 'description': 'CP-690,550 0.02% (0.5 mcg/cm\\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28.'}, {'id': 'BG007', 'title': 'Placebo Twice Daily', 'description': 'CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas twice daily up to Day 28.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.8', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '45.7', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '50.3', 'spread': '17.0', 'groupId': 'BG002'}, {'value': '52.5', 'spread': '13.1', 'groupId': 'BG003'}, {'value': '45.9', 'spread': '10.5', 'groupId': 'BG004'}, {'value': '43.2', 'spread': '15.8', 'groupId': 'BG005'}, {'value': '47.4', 'spread': '13.0', 'groupId': 'BG006'}, {'value': '41.1', 'spread': '17.0', 'groupId': 'BG007'}, {'value': '46.3', 'spread': '13.5', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '66', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'dispFirstSubmitDate': '2010-08-24', 'completionDateStruct': {'date': '2009-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-04', 'studyFirstSubmitDate': '2008-05-13', 'dispFirstSubmitQcDate': '2010-11-12', 'resultsFirstSubmitDate': '2020-12-04', 'studyFirstSubmitQcDate': '2008-05-13', 'dispFirstPostDateStruct': {'date': '2010-11-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-04', 'studyFirstPostDateStruct': {'date': '2008-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point severity scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.'}], 'secondaryOutcomes': [{'measure': "Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions", 'timeFrame': 'Week 4', 'description': 'PGA of Psoriasis: The investigator scored each target lesion on a 5-point scale, reflecting the erythema, induration and scaling separately for each target lesions. Each parameter was scored from 0 to 4, with appropriate morphologic descriptors. The 5-point scale for PGA was: 0, "clear"; 1, "almost clear"; 2, "mild"; 3, "moderate"; 4 "severe". The sum of the 3 scores was divided by 3 to obtain a final PGA score. Total score range: 0 to 4, higher score indicated greater severity of disease. Success was considered as PGA response of "clear" and "almost clear".'}, {'measure': 'Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3', 'timeFrame': 'Baseline, Week 1, 2, 3', 'description': 'TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.'}, {'measure': 'Number of Participants With Administration Site Adverse Events', 'timeFrame': 'Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days)', 'description': 'An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug. Administration site adverse event included documentation of any clinically significant local reaction, such as erosion, vesicles or scabbing.'}, {'measure': 'Drug Plasma Concentrations of CP-690,555', 'timeFrame': '0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28', 'description': 'Concentrations below the limit of quantification (LOQ) were not estimable. The LOQ was 0.1 ng/mL.'}, {'measure': 'Skin Biopsy Drug Concentrations', 'timeFrame': 'Day 28', 'description': 'Skin biopsy drug concentrations was measured via drug levels in dermis and expressed as nanogram of drug per milligram (mg) of dermis weight. Tissue concentration (ng/mg) = (ng drug/mL extraction solvent multiplied by mL extraction solvent) divided by mg tissue weight; 1 mL of extraction solvent was used.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic plaque psoriasis', 'topical treatment'], 'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'pmid': '26267721', 'type': 'DERIVED', 'citation': 'Ports WC, Feldman SR, Gupta P, Tan H, Johnson TR, Bissonnette R. Randomized Pilot Clinical Trial of Tofacitinib Solution for Plaque Psoriasis: Challenges of the Intra-Subject Study Design. J Drugs Dermatol. 2015 Aug;14(8):777-84.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921038&StudyName=Topical%20CP-690%2C550%20For%20Chronic%20Plaque%20Psoriasis', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Study will test effectiveness of an experimental drug applied once or twice daily to two psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having chronic plaque psoriasis for at least 6 months\n* Able to withdraw all prior psoriasis treatments\n* Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or other ultraviolet light sources during the study\n\nExclusion Criteria:\n\n* Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis\n* Pregnant or lactating women\n* Unwilling to use appropriate contraceptive methods'}, 'identificationModule': {'nctId': 'NCT00678561', 'briefTitle': 'Topical CP-690,550 For Chronic Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'PHASE 2A RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, INTRA-INDIVIDUAL COMPARISON TRIAL ASSESSING 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