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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03687359
Registration number
NCT03687359
Ethics application status
Date submitted
6/09/2018
Date registered
27/09/2018
Date last updated
8/07/2025
Titles & IDs
Public title
Observational Evaluation of Atopic Dermatitis in Pediatric Patients
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Scientific title
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
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Secondary ID [1]
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0
U1111-1211-9437
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Secondary ID [2]
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OBS15333
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Universal Trial Number (UTN)
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Trial acronym
PEDISTAD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dermatitis Atopic
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0
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Condition category
Condition code
Skin
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0
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0
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Dermatological conditions
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Skin
0
0
0
0
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Other skin conditions
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Standard of care
Participants with atopic dermatitis (AD) - Participants receive AD therapy as part of their usual care as determined by their physician independent of decision to enroll in the study.
Other interventions: Standard of care
Treatment as per standard practice
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Intervention code [1]
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0
Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Patient demographics
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Assessment method [1]
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0
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Timepoint [1]
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Baseline (Month 0)
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Primary outcome [2]
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0
Medical history of selected atopic diseases and comorbidities
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Assessment method [2]
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0
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Timepoint [2]
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Baseline (Month 0)
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Primary outcome [3]
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0
Age at onset of atopic dermatitis (AD)
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Assessment method [3]
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0
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Timepoint [3]
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Baseline (Month 0)
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Primary outcome [4]
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Personal and family history of AD and selected atopic diseases
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Assessment method [4]
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0
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Timepoint [4]
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Baseline (Month 0)
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Primary outcome [5]
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All prior and current systemic AD treatment
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Assessment method [5]
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0
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Timepoint [5]
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Baseline (Month 0)
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Primary outcome [6]
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All prior and current topical therapy and phototherapy for AD (including dose, route and frequency of administration for all AD treatment)
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Assessment method [6]
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0
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Timepoint [6]
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Baseline (Month 0)
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Primary outcome [7]
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Presence/severity of AD and selected atopic comorbid conditions
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Assessment method [7]
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Timepoint [7]
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Baseline to Month 120
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Primary outcome [8]
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Therapy for selected atopic comorbid conditions
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Assessment method [8]
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Timepoint [8]
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Baseline to Month 120
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Secondary outcome [1]
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Days missed from school for the patient and days missed from work for the primary caregiver due to AD
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Assessment method [1]
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Timepoint [1]
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Baseline to Month 120
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Secondary outcome [2]
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Visits to healthcare professionals (HCPs)
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Assessment method [2]
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Timepoint [2]
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Baseline to Month 120
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Secondary outcome [3]
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Treatments and prescribing patterns for pediatric AD
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Assessment method [3]
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Timepoint [3]
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Baseline to Month 120
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Secondary outcome [4]
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Changes in physician assessment of disease burden (Eczema Area and Severity Index [EASI])
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Assessment method [4]
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Timepoint [4]
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Baseline to Month 120
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Secondary outcome [5]
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Changes in physician assessment of disease burden (Body Surface Area [BSA])
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Assessment method [5]
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Timepoint [5]
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Baseline to Month 120
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Secondary outcome [6]
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Changes in patient/caregiver-reported outcome (PRO): Patient-Oriented Eczema Measure (POEM)
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Assessment method [6]
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Timepoint [6]
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Baseline to Month 120
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Secondary outcome [7]
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Change in PRO: Children's Dermatology Life Quality Index (CDLQI)/ Infant's Dermatitis Quality of Life (IDQOL)
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Assessment method [7]
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Timepoint [7]
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Baseline to Month 120
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Secondary outcome [8]
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Change in PRO: Dermatitis Family Impact (DFI)
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Assessment method [8]
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0
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Timepoint [8]
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Baseline to Month 120
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Secondary outcome [9]
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Change in PRO: Peak Pruritus Numerical Rating Scale (NRS)/ Pruritus (Itch) NRS/ Worst scratching NRS
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Assessment method [9]
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0
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Timepoint [9]
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Baseline to Month 120
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Secondary outcome [10]
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Change in PRO: Caregiver Global Assessment of Disease (CGAD)
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Assessment method [10]
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Timepoint [10]
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Baseline to Month 120
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Secondary outcome [11]
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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
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Assessment method [11]
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0
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Timepoint [11]
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Baseline to Month 120
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Secondary outcome [12]
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Change in PRO: Total Nasal Symptom Score (TNSS)
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Assessment method [12]
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Timepoint [12]
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Baseline to Month 120
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Secondary outcome [13]
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Change in PRO: Pediatric Asthma Questionnaire (PAQ)
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Assessment method [13]
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Timepoint [13]
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Baseline to Month 120
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Secondary outcome [14]
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Change in PRO: Juniper Asthma Control Questionnaire-5 (ACQ-5)
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Assessment method [14]
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Timepoint [14]
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Baseline to Month 120
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Secondary outcome [15]
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Adverse event (AE) reporting
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Assessment method [15]
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Timepoint [15]
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Baseline to Month 120
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Eligibility
Key inclusion criteria
Inclusion criteria:
* Patients with moderate to severe AD, according to the Investigator's assessment;
* Currently receiving systemic treatment (including phototherapy) for atopic dermatitis or currently on topical treatment, but otherwise candidates for systemic treatment.
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Minimum age
0
Years
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Maximum age
11
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
* Concurrent participation in an interventional clinical trial which modifies patient care.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/08/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
21/04/2036
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Actual
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Sample size
Target
1845
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Investigational Site Number : 0360008 - Kogarah
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Recruitment hospital [2]
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Investigational Site Number : 0360011 - Sydney
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Recruitment hospital [3]
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Investigational Site Number : 0360009 - Sydney
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Recruitment hospital [4]
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Investigational Site Number : 0360010 - Melbourne
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Recruitment hospital [5]
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Investigational Site Number : 0360003 - Parkville
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Recruitment hospital [6]
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Investigational Site Number : 0360007 - Richmond
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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2010 - Sydney
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Recruitment postcode(s) [3]
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2560 - Sydney
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Recruitment postcode(s) [4]
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3128 - Melbourne
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Recruitment postcode(s) [5]
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3052 - Parkville
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Recruitment postcode(s) [6]
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3121 - Richmond
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Recruitment outside Australia
Country [1]
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United States of America
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Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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State/province [6]
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Illinois
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Country [7]
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United States of America
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State/province [7]
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Indiana
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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South Carolina
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Texas
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Wisconsin
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Argentina
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Santa Fe
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Tucumán
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Cordoba
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Argentina
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Salta
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San Miguel de Tucuman
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Brazil
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Rio Grande Do Sul
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Brazil
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São Paulo
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Brazil
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Rio de Janeiro
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Brazil
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Changsha
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China
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Chongqing
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Harbin
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Shenzhen
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China
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Bordeaux
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Martigues
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France
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Nantes
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Paris cedex 15
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France
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Toulouse Cedex 9
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Haifa
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Israel
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Kefar Sava
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Israel
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Ramat Gan
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Israel
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Rehovot
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Italy
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Latina
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Italy
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Napoli
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Padova
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Kanagawa
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Mie
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Osaka
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Seoul
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State/province [111]
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Moscow
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Country [112]
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Spain
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State/province [112]
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Asturias
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Country [113]
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Spain
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State/province [113]
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Catalunya [Cataluña]
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Country [114]
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Spain
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State/province [114]
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Madrid
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Country [115]
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Spain
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State/province [115]
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Barcelona
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Primary Objectives: * 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. * To evaluate the time-course of AD and selected atopic comorbidities. Secondary Objectives: * To characterize disease burden and unmet need. * To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching). * To document the real-world effectiveness and safety of treatments.
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Trial website
https://clinicaltrials.gov/study/NCT03687359
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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Clinical Sciences & Operations
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Address
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Sanofi
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Country
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Fax
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Email
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Contact person for public queries
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Trial Transparency email recommended (Toll free number for US & Canada)
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Address
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Phone
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800-633-1610
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03687359
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