Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-30 @ 1:05 AM
Study NCT ID:
NCT01133561
Status:
COMPLETED
Last Update Posted:
2011-02-23
First Post:
2010-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pioglitazone in Psoriasis- A Clinical and Molecular Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-22', 'studyFirstSubmitDate': '2010-05-25', 'studyFirstSubmitQcDate': '2010-05-28', 'lastUpdatePostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment success detected as clinical improvement of skin condition', 'timeFrame': '10 weeks', 'description': 'PASI improvement by at least 50% from baseline before treatment(Psoriasis Area and Severity Index)= PASI-50'}], 'secondaryOutcomes': [{'measure': 'Fasting serum insulin reduction from baseline before treatment', 'timeFrame': '10 weeks'}, {'measure': 'C-reactive protein titre reduction from baseline value before treatment', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['psoriasis', 'insulin resistance', 'metabolic syndrome', 'pioglitazone', 'randomized control trial'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': "The study will assess the effectiveness of Pioglitazone on cellular and clinical levels in terms of improvement of both skin and systemic manifestations of psoriasis.\n\nThe investigators assume that pioglitazone (one of thiazolidinediones readily available in Egypt), can regulate keratinocytes' disordered proliferation observed in psoriasis, in addition to improving the insulin resistance in peripheral tissues observed in many psoriatic patients and causing metabolic syndrome. This will allow to give a safer therapy than the available ones for psoriasis and to treat the patient in a more global perspective."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years and less than 65 years.\n* Plaque psoriasis vulgaris ≥ 10% (apart from palmoplantar psoriasis which will be included).\n\nExclusion Criteria:\n\n* Age less than 18 years and more than 65 years\n* Mild psoriasis less than 10% body surface area\n* Erythrodermic or pustular psoriasis\n* Liver disease, cardiac disease (suspected from history or ECG), or any other major medical disorder detected by history.\n* Pregnant and lactating females.'}, 'identificationModule': {'nctId': 'NCT01133561', 'briefTitle': 'Pioglitazone in Psoriasis- A Clinical and Molecular Study.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': "The CLINICAL And MOLECULAR EFFECTS Of An INSULIN SENSITIZING DRUG: 'PIOGLITAZONE'On PSORIASIS TREATMENT", 'orgStudyIdInfo': {'id': 'VHafez 2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'actozone A', 'description': 'Pioglitazone 30 mg tablets daily', 'interventionNames': ['Drug: actozone A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'actozone B', 'description': 'placebo', 'interventionNames': ['Drug: actozone B']}], 'interventions': [{'name': 'actozone A', 'type': 'DRUG', 'description': 'pioglitazone 30 mg tablet , once daily dose for 10 weeks', 'armGroupLabels': ['actozone A']}, {'name': 'actozone B', 'type': 'DRUG', 'description': 'one tablet of vehicle without active ingredient pioglitazone', 'armGroupLabels': ['actozone B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Dermatology department of cairo university faculty of medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Manal AW Bosseila, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University-Dermatology department'}, {'name': 'Mona RE Abdel Halim, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo university- Dermatology department'}, {'name': 'Mohamed I Sheta, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo university- Internal medicine department'}, {'name': 'Olfat G Shaker, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University- Biochemistry department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Vanessa Galal Hafez/ Assistant lecturer of Dermatology', 'oldOrganization': 'Dermatology department, Faculty of medicine, Cairo university'}}}}