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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
19/11/2024

Titles & IDs
Public title
Observational Evaluation of Atopic Dermatitis in Pediatric Patients
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
Secondary ID [1] 0 0
U1111-1211-9437
Secondary ID [2] 0 0
OBS15333
Universal Trial Number (UTN)
Trial acronym
PEDISTAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermatitis Atopic 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient demographics
Timepoint [1] 0 0
Baseline (Month 0)
Primary outcome [2] 0 0
Medical history of selected atopic diseases and comorbidities
Timepoint [2] 0 0
Baseline (Month 0)
Primary outcome [3] 0 0
Age at onset of atopic dermatitis (AD)
Timepoint [3] 0 0
Baseline (Month 0)
Primary outcome [4] 0 0
Personal and family history of AD and selected atopic diseases
Timepoint [4] 0 0
Baseline (Month 0)
Primary outcome [5] 0 0
All prior and current systemic AD treatment
Timepoint [5] 0 0
Baseline (Month 0)
Primary outcome [6] 0 0
All prior and current topical therapy and phototherapy for AD (including dose, route and frequency of administration for all AD treatment)
Timepoint [6] 0 0
Baseline (Month 0)
Primary outcome [7] 0 0
Presence/severity of AD and selected atopic comorbid conditions
Timepoint [7] 0 0
Baseline to Month 120
Primary outcome [8] 0 0
Therapy for selected atopic comorbid conditions
Timepoint [8] 0 0
Baseline to Month 120
Secondary outcome [1] 0 0
Days missed from school for the patient and days missed from work for the primary caregiver due to AD
Timepoint [1] 0 0
Baseline to Month 120
Secondary outcome [2] 0 0
Visits to healthcare professionals (HCPs)
Timepoint [2] 0 0
Baseline to Month 120
Secondary outcome [3] 0 0
Treatments and prescribing patterns for pediatric AD
Timepoint [3] 0 0
Baseline to Month 120
Secondary outcome [4] 0 0
Changes in physician assessment of disease burden (Eczema Area and Severity Index [EASI])
Timepoint [4] 0 0
Baseline to Month 120
Secondary outcome [5] 0 0
Changes in physician assessment of disease burden (Body Surface Area [BSA])
Timepoint [5] 0 0
Baseline to Month 120
Secondary outcome [6] 0 0
Changes in patient/caregiver-reported outcome (PRO): Patient-Oriented Eczema Measure (POEM)
Timepoint [6] 0 0
Baseline to Month 120
Secondary outcome [7] 0 0
Change in PRO: Children's Dermatology Life Quality Index (CDLQI)/ Infant's Dermatitis Quality of Life (IDQOL)
Timepoint [7] 0 0
Baseline to Month 120
Secondary outcome [8] 0 0
Change in PRO: Dermatitis Family Impact (DFI)
Timepoint [8] 0 0
Baseline to Month 120
Secondary outcome [9] 0 0
Change in PRO: Peak Pruritus Numerical Rating Scale (NRS)/ Pruritus (Itch) NRS/ Worst scratching NRS
Timepoint [9] 0 0
Baseline to Month 120
Secondary outcome [10] 0 0
Change in PRO: Caregiver Global Assessment of Disease (CGAD)
Timepoint [10] 0 0
Baseline to Month 120
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Baseline to Month 120
Secondary outcome [12] 0 0
Change in PRO: Total Nasal Symptom Score (TNSS)
Timepoint [12] 0 0
Baseline to Month 120
Secondary outcome [13] 0 0
Change in PRO: Pediatric Asthma Questionnaire (PAQ)
Timepoint [13] 0 0
Baseline to Month 120
Secondary outcome [14] 0 0
Change in PRO: Juniper Asthma Control Questionnaire-5 (ACQ-5)
Timepoint [14] 0 0
Baseline to Month 120
Secondary outcome [15] 0 0
Adverse event (AE) reporting
Timepoint [15] 0 0
Baseline to Month 120

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.
Minimum age
0 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/04/2036
Actual
Sample size
Target
1845
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Investigational Site Number : 0360008 - Kogarah
Recruitment hospital [2] 0 0
Investigational Site Number : 0360011 - Sydney
Recruitment hospital [3] 0 0
Investigational Site Number : 0360009 - Sydney
Recruitment hospital [4] 0 0
Investigational Site Number : 0360001 - Westmead
Recruitment hospital [5] 0 0
Investigational Site Number : 0360010 - Melbourne
Recruitment hospital [6] 0 0
Investigational Site Number : 0360003 - Parkville
Recruitment hospital [7] 0 0
Investigational Site Number : 0360007 - Richmond
Recruitment hospital [8] 0 0
Investigational Site Number : 0360004 - Fremantle
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
2560 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
3128 - Melbourne
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment postcode(s) [7] 0 0
3121 - Richmond
Recruitment postcode(s) [8] 0 0
6160 - Fremantle
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03687359
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.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free number for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03687359