Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-26 @ 8:06 AM
Study NCT ID:
NCT05023668
Status:
UNKNOWN
Last Update Posted:
2021-08-26
First Post:
2021-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
China Atopic Dermatitis Registry Study
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-20', 'studyFirstSubmitDate': '2021-08-16', 'studyFirstSubmitQcDate': '2021-08-20', 'lastUpdatePostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physician evaluated effectiveness of Atopic Dermatitis therapies in real life', 'timeFrame': 'At Month 12', 'description': 'Physician-reported outcome tool, SCORAD index, will be used to evaluate the objective severity of clinical signs of Atopic Dermatitis .'}, {'measure': 'Patient-reported disease symptoms after Atopic Dermatitis therapies in real life', 'timeFrame': 'At Month 12', 'description': 'Patient Oriented Eczema Measure (POEM) will be used to assess disease symptoms'}, {'measure': 'Patient-reported severity of pruritus after Atopic Dermatitis therapies in real life', 'timeFrame': 'At Month 12', 'description': 'Peak Pruritus Numerical Rating Scale (NRS) will be used to assess severity of pruritus.'}, {'measure': 'Patient-reported disease control after Atopic Dermatitis therapies in real life', 'timeFrame': 'At Month 12', 'description': 'Atopic Dermatitis Control Tool (ADCT) will be used to assess long term disease control.'}, {'measure': 'Patient-reported quality of life after Atopic Dermatitis therapies in real life', 'timeFrame': 'At Month 12', 'description': 'Dermatology Life Quality Index (DLQI) will be used to assess quality of life, and DLQI for children (cDLQL) will be used for adolescence patients.'}, {'measure': 'The Atopic Dermatitis related economic burden', 'timeFrame': 'At Month 12', 'description': 'Economic burden of Atopic Dermatitis will be evaluated using the cost of hospitalizations and outpatient visits associated with Atopic Dermatitis during the past one year.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dermatitis, Atopic']}, 'referencesModule': {'references': [{'pmid': '40971027', 'type': 'DERIVED', 'citation': 'Liu P, Lin B, Shen Y, Lu Y, Li J, Lv D, Yao X, Man X, Fang H, Jiang G, Yu N, Liu D, Zhan S, Zhang J. The ChinaSTAD Chinese Registry in Patients with Moderate-To-Severe Atopic Dermatitis Not Controlled by Topical Therapy: Baseline Characteristics, Disease Burden and Treatment. Dermatol Ther (Heidelb). 2025 Nov;15(11):3377-3389. doi: 10.1007/s13555-025-01540-w. Epub 2025 Sep 19.'}]}, 'descriptionModule': {'briefSummary': 'This regestry study is aimed to characterize the medical care and drug treatment under real-life conditions among Chinese patients with moderate to severe Atopic Dermatitis who are not well controlled by topical therapies.', 'detailedDescription': 'Atopic dermatitis (AD) is a chronic recurrent inflammatory skin disease, resulting in itchy, red, and skin lesion. A survey conducted in 2014 in 39 tertiary hospitals of 15 provinces in mainland China has shown that the incidence of AD in outpatients (7.8%) has been raised in recent years.\n\nAmong topical therapy of AD, corticosteroids are first line therapy. In patients with extensive and severe dermatitis, topical therapy may be insufficient. Such patients may require the addition of either oral corticosteroid or systemic immunosuppressive therapy and even phototherapy. There is no clear recommendation treatment for each kind of patients with different severity yet and there are still huge unmet medical needs for treatment. There is not clear recommendation grade for these therapy in Chinese AD guideline and no published data to demonstrate current treatment situation in real clinical practise.\n\nThe goal of clinical registry study is to document the use and effectiveness of therapeutic interventions under real-life conditions. This study will help understand the clinical characteristics, treatment utilization, treatment patterns, as well as disease-related outcomes and cost among AD patients in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese moderate-to-severe atopic dermatitis patients who are not controlled by topical therapy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age≥12;\n* AD according to Williams diagnosis criteria (see Appendix 1);\n* Moderate to severe AD that inadequately controlled by topical therapy\n* Moderate-to-severe: SCORAD score≥25; or\n* Inadequately controlled by topic therapies: Determined by physicians.\n\nExclusion Criteria:\n\n* No.'}, 'identificationModule': {'nctId': 'NCT05023668', 'briefTitle': 'China Atopic Dermatitis Registry Study', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'China Atopic Dermatitis Registry Study: a Chinese Registry Study in Moderate-to-severe Atopic Dermatitis Patients Not Controlled by Topical Therapy', 'orgStudyIdInfo': {'id': 'SGZ-2020-12888'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy', 'description': 'Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ping Liu', 'role': 'CONTACT', 'email': 'llppliuping@126.com', 'phone': '010 88325472'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jianzhong Zhang', 'role': 'CONTACT', 'email': 'rmzjz@126.com', 'phone': '010-88325472'}, {'name': 'Ping Liu', 'role': 'CONTACT', 'email': 'llppliuping@126.com', 'phone': '010-88325472'}], 'overallOfficials': [{'name': 'Jianzhong Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chairman, Department of Dermatology', 'investigatorFullName': 'Zhang jianzhong', 'investigatorAffiliation': "Peking University People's Hospital"}}}}