Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:33 AM
Study NCT ID:
NCT07323394
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-23
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Study on the Impact of Atopic Dermatitis From a Caregiver Perspective
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-22', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2025-12-22', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate work productivity loss in caregivers of children with mild or moderate atopic dermatitis.', 'timeFrame': 'At recruitment', 'description': 'Using the Work Productivity and Activity Impairment questionnaire. This questionnaire provides a quantitative measure of impairment over the last 7 days and includes four metrics: absenteeism (work time missed because of health issues during the past 7 days), presenteeism (impairment while working due to health issues during the past 7 days), overall work productivity loss (combination of absenteeism and presenteeism), and activity impairment.'}], 'secondaryOutcomes': [{'measure': 'To estimate family burden of mild to moderate atopic dermatitis in children, as reported by caregivers', 'timeFrame': 'At recruitment', 'description': 'The Dermatitis Family Impact (DFI) questionnaire will be administered to caregivers to evaluate the family burden of pediatric atopic dermatitis. The DFI is a validated, 10-item instrument specifically developed for atopic dermatitis, covering domains such as housework, feeding, sleep, leisure activities, time spent shopping, expenditure, physical fatigue, emotional distress, relationships, helping with treatment, with a 7-day recall period. Each item is scored on a 4-point Likert scale ("Not at all = 0" to "Very much = 3"), with higher total scores indicating greater impact'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atopic dermatitis', 'quality of life', 'real-world'], 'conditions': ['Atopic Dermatitis', 'Eczema Atopic Dermatitis', 'Eczema', 'Caregiver', 'Burden']}, 'descriptionModule': {'briefSummary': 'This study will address this gap by providing comprehensive data on disease burden from a caregiver perspective in a Canadian population, ultimately supporting improved clinical decision-making and healthcare resource allocation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Caregiver of a child aged ≥2 to ≤11 years with mild to moderate atopic dermatitis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged ≥18 years;\n2. Caregiver of a child aged ≥2 to ≤11 years with mild to moderate atopic dermatitis;\n3. Able to read and understand French or English;\n4. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Caregivers whose child has been diagnosed with severe atopic dermatitis ;\n2. Caregivers whose child is currently treated with oral or topical Janus Kinase Inhibitor);\n3. Caregivers whose child is currently participating in a clinical trial for atopic dermatitis;\n4. Other parent or caregiver within the household of the child with atopic dermatitis.'}, 'identificationModule': {'nctId': 'NCT07323394', 'briefTitle': 'Real-World Study on the Impact of Atopic Dermatitis From a Caregiver Perspective', 'organization': {'class': 'OTHER', 'fullName': 'PeriPharm'}, 'officialTitle': 'Real-World Study on the Impact of Atopic Dermatitis From a Caregiver Perspective', 'orgStudyIdInfo': {'id': 'PROxy96AD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Caregiver of child with atopic dermatitis', 'description': 'Caregiver of a child aged ≥2 to ≤11 years with mild to moderate atopic dermatitis', 'interventionNames': ['Other: No Intervention: Observational Cohort']}], 'interventions': [{'name': 'No Intervention: Observational Cohort', 'type': 'OTHER', 'description': 'No specific intervention is assess in this study. Observational cohort.', 'armGroupLabels': ['Caregiver of child with atopic dermatitis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jean Lachaine, Ph. D.', 'role': 'CONTACT', 'email': 'jean.lachaine@peripharm.com', 'phone': '514-731-8207'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PeriPharm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}