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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03687359




Registration number
NCT03687359
Ethics application status
Date submitted
6/09/2018
Date registered
27/09/2018
Date last updated
15/12/2023

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
Demographics
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Age at AD onset
Timepoint [2] 0 0
Baseline
Primary outcome [3] 0 0
Time from AD onset to initiation of therapy
Timepoint [3] 0 0
Baseline
Primary outcome [4] 0 0
Type of current AD therapy
Timepoint [4] 0 0
Baseline
Primary outcome [5] 0 0
Presence of AD and selected comorbid conditions
Timepoint [5] 0 0
Baseline to Month 60
Secondary outcome [1] 0 0
Percentage of patients using specific AD therapies and initiating new therapies
Timepoint [1] 0 0
Baseline to Month 60
Secondary outcome [2] 0 0
Eczema Area and Severity Index (EASI)
Timepoint [2] 0 0
Baseline to Month 60
Secondary outcome [3] 0 0
Body Surface Area (BSA) percentage affected by AD
Timepoint [3] 0 0
Baseline to Month 60
Secondary outcome [4] 0 0
Patient Oriented Eczema Measure (POEM) questionnaire
Timepoint [4] 0 0
Baseline to Month 60
Secondary outcome [5] 0 0
Children's Dermatology Life Quality Index (CDLQI)
Timepoint [5] 0 0
Baseline to Month 60
Secondary outcome [6] 0 0
Infant's Dermatitis Quality of Life (IDQOL)
Timepoint [6] 0 0
Baseline to Month 60
Secondary outcome [7] 0 0
Dermatitis Family Impact (DFI) questionnaires
Timepoint [7] 0 0
Baseline to Month 60
Secondary outcome [8] 0 0
Peak Pruritus Numerical Rating Scale (NRS)
Timepoint [8] 0 0
Baseline to Month 60
Secondary outcome [9] 0 0
Worst scratching NRS questionnaires
Timepoint [9] 0 0
Baseline to Month 60
Secondary outcome [10] 0 0
Caregiver Global Assessment of Disease (CGAD) questionnaire
Timepoint [10] 0 0
Baseline to Month 60
Secondary outcome [11] 0 0
Total Nasal Symptom Score (TNSS) questionnaire
Timepoint [11] 0 0
Baseline to Month 60
Secondary outcome [12] 0 0
Days missed from school for the patient and days missed from work for the primary caregiver due to AD
Timepoint [12] 0 0
Baseline to Month 60
Secondary outcome [13] 0 0
Number of visits to healthcare professionals
Timepoint [13] 0 0
Baseline to Month 60
Secondary outcome [14] 0 0
Incidence of adverse events
Timepoint [14] 0 0
Baseline to Month 60

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
1856
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Investigational Site Number : 0360009 - Campbelltown
Recruitment hospital [2] 0 0
Investigational Site Number : 0360008 - Kogarah
Recruitment hospital [3] 0 0
Investigational Site Number : 0360001 - Westmead
Recruitment hospital [4] 0 0
Investigational Site Number : 0360010 - Box Hill
Recruitment hospital [5] 0 0
Investigational Site Number : 0360003 - Parkville
Recruitment hospital [6] 0 0
Investigational Site Number : 0360007 - Richmond
Recruitment hospital [7] 0 0
Investigational Site Number : 0360004 - Fremantle
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
3121 - Richmond
Recruitment postcode(s) [7] 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/ct2/show/NCT03687359
Trial related presentations / publications
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/ct2/show/NCT03687359