Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT03687359
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2018-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Evaluation of Atopic Dermatitis in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, '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': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1860}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2035-07-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2018-09-25', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-07-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient demographics', 'timeFrame': 'Baseline (Month 0)'}, {'measure': 'Medical history of selected atopic diseases and comorbidities', 'timeFrame': 'Baseline (Month 0)'}, {'measure': 'Age at onset of atopic dermatitis (AD)', 'timeFrame': 'Baseline (Month 0)'}, {'measure': 'Personal and family history of AD and selected atopic diseases', 'timeFrame': 'Baseline (Month 0)'}, {'measure': 'All prior and current systemic AD treatment', 'timeFrame': 'Baseline (Month 0)'}, {'measure': 'All prior and current topical therapy and phototherapy for AD (including dose, route and frequency of administration for all AD treatment)', 'timeFrame': 'Baseline (Month 0)'}, {'measure': 'Presence/severity of AD and selected atopic comorbid conditions', 'timeFrame': 'Baseline to Month 120'}, {'measure': 'Therapy for selected atopic comorbid conditions', 'timeFrame': 'Baseline to Month 120'}], 'secondaryOutcomes': [{'measure': 'Days missed from school for the patient and days missed from work for the primary caregiver due to AD', 'timeFrame': 'Baseline to Month 120'}, {'measure': 'Visits to healthcare professionals (HCPs)', 'timeFrame': 'Baseline to Month 120'}, {'measure': 'Treatments and prescribing patterns for pediatric AD', 'timeFrame': 'Baseline to Month 120'}, {'measure': 'Changes in physician assessment of disease burden (Eczema Area and Severity Index [EASI])', 'timeFrame': 'Baseline to Month 120'}, {'measure': 'Changes in physician assessment of disease burden (Body Surface Area [BSA])', 'timeFrame': 'Baseline to Month 120'}, {'measure': 'Changes in patient/caregiver-reported outcome (PRO): Patient-Oriented Eczema Measure (POEM)', 'timeFrame': 'Baseline to Month 120'}, {'measure': "Change in PRO: Children's Dermatology Life Quality Index (CDLQI)/ Infant's Dermatitis Quality of Life (IDQOL)", 'timeFrame': 'Baseline to Month 120'}, {'measure': 'Change in PRO: Dermatitis Family Impact (DFI)', 'timeFrame': 'Baseline to Month 120'}, {'measure': 'Change in PRO: Peak Pruritus Numerical Rating Scale (NRS)/ Pruritus (Itch) NRS/ Worst scratching NRS', 'timeFrame': 'Baseline to Month 120'}, {'measure': 'Change in PRO: Caregiver Global Assessment of Disease (CGAD)', 'timeFrame': 'Baseline to Month 120'}, {'measure': 'Change in PRO: Days missed from school for the patient and days missed from work for the primary caregiver due to AD since last visit', 'timeFrame': 'Baseline to Month 120'}, {'measure': 'Change in PRO: Total Nasal Symptom Score (TNSS)', 'timeFrame': 'Baseline to Month 120'}, {'measure': 'Change in PRO: Pediatric Asthma Questionnaire (PAQ)', 'timeFrame': 'Baseline to Month 120'}, {'measure': 'Change in PRO: Juniper Asthma Control Questionnaire-5 (ACQ-5)', 'timeFrame': 'Baseline to Month 120'}, {'measure': 'Adverse event (AE) reporting', 'timeFrame': 'Baseline to Month 120'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dermatitis Atopic']}, 'referencesModule': {'references': [{'pmid': '40971133', 'type': 'DERIVED', 'citation': 'Paller AS, Marcoux D, Ramien M, Baselga E, Carvalho VO, Ardusso LRF, de Graaf M, Pasmans S, Toledo-Bahena M, Rubin C, Joyce JC, Lee LW, Gupta R, Adams B, Ardeleanu M, Zhang A. Systemic Treatments in Moderate-to-Severe Atopic Dermatitis in Pediatric Patients up to 12 Years of Age: Real-World Treatment Outcomes from the PEDISTAD Registry. Am J Clin Dermatol. 2025 Nov;26(6):1031-1043. doi: 10.1007/s40257-025-00962-8. Epub 2025 Sep 19.'}, {'pmid': '32209624', 'type': 'DERIVED', 'citation': 'Paller AS, Guttman-Yassky E, Irvine AD, Baselga E, de Bruin-Weller M, Jayawardena S, Zhang A, Mina-Osorio P, Rizova E, Ozturk ZE. Protocol for a prospective, observational, longitudinal study in paediatric patients with moderate-to-severe atopic dermatitis (PEDISTAD): study objectives, design and methodology. BMJ Open. 2020 Mar 24;10(3):e033507. doi: 10.1136/bmjopen-2019-033507.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objectives:\n\n* To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable.\n* To evaluate the time-course of AD and selected atopic comorbidities.\n\nSecondary Objectives:\n\n* To characterize disease burden and unmet need.\n* To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching).\n* To document the real-world effectiveness and safety of treatments.', 'detailedDescription': 'The study duration is 120 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '0 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients with moderate to severe AD whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients with moderate to severe AD, according to the Investigator's assessment;\n* Currently receiving systemic treatment (including phototherapy) for atopic dermatitis or currently on topical treatment, but otherwise candidates for systemic treatment.\n\nExclusion criteria:\n\n* Concurrent participation in an interventional clinical trial which modifies patient care.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT03687359', 'acronym': 'PEDISTAD', 'briefTitle': 'Observational Evaluation of Atopic Dermatitis in Pediatric Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Prospective, Observational, Longitudinal Study in Pediatric Patients With Moderate to Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable', 'orgStudyIdInfo': {'id': 'OBS15333'}, 'secondaryIdInfos': [{'id': 'U1111-1211-9437', 'type': 'REGISTRY', 'domain': 'ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with atopic dermatitis (AD)', 'description': 'Participants receive AD therapy as part of their usual care as determined by their physician independent of decision to enroll in the study.', 'interventionNames': ['Other: Standard of care']}], 'interventions': [{'name': 'Standard of care', 'type': 'OTHER', 'description': 'Treatment as per standard practice', 'armGroupLabels': ['Participants with atopic dermatitis (AD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'C Squared Research Center- Site Number : 8400068', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cahaba Dermatology & Skin Health Center- Site Number : 8400046', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36117', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'C2 Research Center, LLC- Site Number : 8400071', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital, Inc.- Site Number : 8400015", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Institute- Site Number : 8400028', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Axis Clinical Trials- Site Number : 8400025', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93637', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': 'Madera Family Medical Group- Site Number : 8400054', 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Carey Chronis, MD, FAAP- Site Number : 8400033', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '33431', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Daxia Trials- Site Number : 8400082', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33487', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Frieder Dermatology- Site Number : 8400085', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology, LLC- Site Number : 8400072', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33441', 'city': 'Deerfield Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Green Dermatology and Cosmetic Center. 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