Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2026-04-11 @ 8:50 PM
Study NCT ID:
NCT01356004
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2011-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effective Study of Live Attenuated Varicella Vaccine to Treat Severe Resistant Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-18', 'studyFirstSubmitDate': '2011-05-17', 'studyFirstSubmitQcDate': '2011-05-18', 'lastUpdatePostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with PASI score improvement as a Measure of effective treatment', 'timeFrame': '12 weeks', 'description': "the clinical evaluation of our patients through the Psoriasis Area Severity Index (PASI) score calculation at each visit.\n\nThe final patient's response was rated according to the physician global assessment (PGA) based on the final improvement of the PASI score as worse, poor (0-24% improvement in PASI), fair (25-50% improvement in PASI), good (50-74% improvement in PASI), excellent (75-99% improvement in PASI), or cleared (100% improvement in PASI)."}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['severe resistant'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'Immunotherapy was reported in the treatment of psoriasis. Treatment of resistant psoriasis may be difficult and cyclosporine can induce some remission.\n\nThe investigators hypothesized that the combined use of live attenuated varicella vaccine as an adjuvant therapy to low dose cyclosporine in the treatment of severe resistant psoriasis can give positive responses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe psoriasis: At least 30% of body involved) according to the rule of nine.\n* Resistance to conventional therapy (PUVA, methotrexate, retinoids):\n\n(Maximum PASI 50% improvement while on treatment for a duration not less than 6 months).\n\n* Immunologically competent individuals with\n* Seropositive for the varicella antibodies\n\nExclusion Criteria:\n\n* Any contraindication to live attenuated varicella vaccine\n* Any contraindication to cyclosporine'}, 'identificationModule': {'nctId': 'NCT01356004', 'briefTitle': 'Effective Study of Live Attenuated Varicella Vaccine to Treat Severe Resistant Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Live Attenuated Varicella Vaccine: A New Effective Adjuvant Weapon in the Battlefield Against Severe Resistant Psoriasis, a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CairoU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chicken pox vaccine, efficacy', 'interventionNames': ['Drug: live attenuated chicken pox vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'saline, efficacy', 'interventionNames': ['Drug: saline, efficacy']}], 'interventions': [{'name': 'live attenuated chicken pox vaccine', 'type': 'DRUG', 'description': 'Each immunizing dose was given subcutaneously (SC) in the form of 0.5 ml reconstituted vaccine which contains not less than 1033 plaque forming units (PFU) of the attenuated varicella-zoster-virus (VZV), which meets the World Health Organization (WHO) requirements for biological substances and for varicella vaccines. Doses were given 3 weeks apart for a total duration of 12 weeks (3 months).', 'armGroupLabels': ['chicken pox vaccine, efficacy']}, {'name': 'saline, efficacy', 'type': 'DRUG', 'description': '4 doses of SC saline (0.5 ml) -as a placebo- in the same pattern as group A patients', 'armGroupLabels': ['saline, efficacy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Mohammad El Darouti', 'oldOrganization': 'Faculty of Medicine, Cairo University'}}}}