Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT00367393
Status:
COMPLETED
Last Update Posted:
2017-02-24
First Post:
2006-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reconstitution With Pimecrolimus Cream 1% of Steroid-damaged Skin in Adults With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C117268', 'term': 'pimecrolimus'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2006-08-21', 'studyFirstSubmitQcDate': '2006-08-21', 'lastUpdatePostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Decrease of the Dermatophot (a combination of a dermatoscope and a camera) score on skin deterioration and spider veins from baseline to end of the study', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': '• Epidermal thickness by optical coherence tomography at selected investigational centers', 'timeFrame': '48 weeks'}, {'measure': 'Skin thickness by ultrasound at selected investigational centers', 'timeFrame': '48 weeks'}, {'measure': 'Epidermal thickness by 3mm punch biopsies (optional)', 'timeFrame': '48 weeks'}, {'measure': 'Skin metabolism by suction blisters.', 'timeFrame': '48 weeks'}, {'measure': "Investigator's Global Assessment (IGA)", 'timeFrame': '48 weeks'}]}, 'conditionsModule': {'keywords': ['Pimecrolimus, skin atrophy, dermoscopy, atopic dermatitis, eczema'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Reference: Thaci D et al TBD. CORTICOSTEROID-INDUCED SKIN DAMAGE IMPROVED WITH PIMECROLIMUS CREAM 1% TREATMENT: A 1-YEAR STUDY IN ADULTS WITH ATOPIC ECZEMA. European Academy of Dermatology and Venereology - 17th Congress. 2008; www.eadv.org'}]}, 'descriptionModule': {'briefSummary': 'Topical steroid use may lead to skin deterioration and spider veins. This study will examine long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and its effect on skin reconstitution of steroid-damaged skin and disease control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinically diagnosed AD\n* almost clear to mild AD (local IGA \\[target lesions face and cubital areas\\] score of 1-3)\n* clinically (i.e. to the unaided eye) evident skin atrophy due to long-term topical steroid use\n* Dermatophot Score (DPS - composed of skin atrophy and telangiectasia) of 4-6 on at least two target areas\n\nExclusion Criteria:\n\n* Phototherapy or systemic therapy known or suspected to have an effect on AD within 4 weeks prior to study entry\n* Topical therapy known or suspected to have an effect on AD within 7 days prior to study entry or systemic corticosteroids within 4 weeks prior to study entry\n* Clinical conditions other than AD that according to investigator can interfere with the Dermatophot evaluation'}, 'identificationModule': {'nctId': 'NCT00367393', 'briefTitle': 'Reconstitution With Pimecrolimus Cream 1% of Steroid-damaged Skin in Adults With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open-label Multicenter 12-month Long Term Study on Skin Reconstitution With Pimecrolimus Cream 1% in Adult Patients With Atopic Eczema and Corticosteroid Induced Skin Damage', 'orgStudyIdInfo': {'id': 'CASM981CDE20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Pimecrolimus cream 1%', 'interventionNames': ['Drug: Pimecrolimus cream 1%']}], 'interventions': [{'name': 'Pimecrolimus cream 1%', 'type': 'DRUG', 'otherNames': ['ASM981'], 'description': 'Pimecrolimus cream 1% bid, as needed', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Novartis', 'country': 'Germany', 'facility': 'Novartis'}], 'overallOfficials': [{'name': 'Novartis Pharm', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis'}}}}