Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-28 @ 4:54 AM
Study NCT ID:
NCT04976868
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2021-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SCORAD', 'timeFrame': 'The study ends after the Maintenance Period of at least 3 months allowing certain flexibility to respond to the routine practice. End of Study will be approx. 6 months after the inclusion depending length of the Elidel® Treatment Period.', 'description': 'The primary outcome measure is the "change from baseline in SCORAD INDEX". The achievable score in SCORAD INDEX range from 0 to 103. The classification of severity would be as follows mild (\\<25), moderate (25-50) and severe (≥50).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The primary objective of the present multicentre, prospective, non-interventional study (NIS) is gathering knowledge on the actual use and effectiveness of Elidel® in Chinese patients with mild to moderate AD affecting sensitive skin areas in routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese patients at least 2 years old with mild to moderate atopic dermatitis affecting sensitive skin areas', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients of Chinese ethnicity\n* Patients at least 2 years old\n* Signed informed consent from patient and if applicable from parent(s) or legal guardian(s) in compliance with local requirements\n* Patients with mild to moderate AD and depending on the age:\n* Patients 2-12 years must have:\n\n \\- SCORAD Index \\< 50\n* Patients 13 years and older must have:\n\n * Affecting sensitive skin areas (e.g. face, intertriginous sites, anogenital area)\n * SCORAD Index \\< 50 and IGA in sensitive skin areas ≤ 3\n\nExclusion Criteria:\n\n* Patients for whom Elidel® is not recommended accordingly to the Package Insert\n* Patients with severe atopic dermatitis (SCORAD Index ≥ 50 or IGA in sensitive skin \\> 3)\n* Receiving systemic glucocorticoids, antibiotics, antifungals, immunomodulators, inhibitors, antihistamines and ultraviolet radiation therapy within the last 4 weeks before inclusion;\n* Receiving any topical AD-effective drugs within the last 2 weeks before inclusion;\n* Pregnant and/or breastfeeding women\n* Patients or parent(s) / legal guardian (as applicable) that are not able to fulfil study requirements according to physician's opinion\n* Patients or parent(s) / legal guardian (as applicable) that refuse to participate to the study"}, 'identificationModule': {'nctId': 'NCT04976868', 'briefTitle': 'Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viatris Inc.'}, 'officialTitle': 'Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis', 'orgStudyIdInfo': {'id': '3328'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pimecrolimus Cream 1% - Elidel®', 'description': 'Elidel® as prescribed within routine clinical practice', 'interventionNames': ['Drug: Pimecrolimus 1% Top Cream']}], 'interventions': [{'name': 'Pimecrolimus 1% Top Cream', 'type': 'DRUG', 'description': 'Elidel® as prescribed within routine clinical practice', 'armGroupLabels': ['Pimecrolimus Cream 1% - Elidel®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': "Beijing children's Hospital, Capital Medical University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': "Children's Hospital Capital Institute of Pediatrics", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'country': 'China', 'facility': "Children's hospital of Chongqing medical university", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'The third affiliated hospital, sun yat-sen university', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shenyang', 'country': 'China', 'facility': 'The first Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenzhen', 'country': 'China', 'facility': 'Peking University Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Wuhan', 'country': 'China', 'facility': 'Tongji Medical College Huazhong University of Science & Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mylan Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medicine Meda Pharmaceutical Information Consultancy (Beijing) Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}