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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03687359
Ethics application status
Date submitted
6/09/2018
Date registered
27/09/2018
Date last updated
9/10/2020

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 - Age, sex, race, ethnicity, body weight and height
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Age at AD onset - Age of study patients at time of AD onset
Timepoint [2] 0 0
Baseline
Primary outcome [3] 0 0
Time from AD onset to initiation of therapy - Duration from onset of AD to start of AD therapy
Timepoint [3] 0 0
Baseline
Primary outcome [4] 0 0
Type of current AD therapy - Type of therapy administered to treat AD (e.g., systemic, topical, other)
Timepoint [4] 0 0
Baseline
Primary outcome [5] 0 0
Presence of AD and selected comorbid conditions - Percentage of patients with AD and selected comorbidities (e.g., asthma and allergic rhinitis) at baseline and during study
Timepoint [5] 0 0
Baseline to Month 60
Secondary outcome [1] 0 0
Percentage of patients using specific AD therapies and initiating new therapies - 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) - EASI score as assessed by physician
Timepoint [2] 0 0
Baseline to Month 60
Secondary outcome [3] 0 0
Body Surface Area (BSA) percentage affected by AD - BSA score as assessed by physician
Timepoint [3] 0 0
Baseline to Month 60
Secondary outcome [4] 0 0
Patient Oriented Eczema Measure (POEM) questionnaire - POEM score as reported by the participant's caregiver
Timepoint [4] 0 0
Baseline to Month 60
Secondary outcome [5] 0 0
Children's Dermatology Life Quality Index (CDLQI) - CDLQI score as reported by the participant
Timepoint [5] 0 0
Baseline to Month 60
Secondary outcome [6] 0 0
Infant's Dermatitis Quality of Life (IDQOL) - IDQOL score as reported by the participant's caregiver
Timepoint [6] 0 0
Baseline to Month 60
Secondary outcome [7] 0 0
Dermatitis Family Impact (DFI) questionnaires - DFI score as reported by the participant's caregiver
Timepoint [7] 0 0
Baseline to Month 60
Secondary outcome [8] 0 0
Peak Pruritus Numerical Rating Scale (NRS) - Peak Pruritus NRS score as reported by the participant
Timepoint [8] 0 0
Baseline to Month 60
Secondary outcome [9] 0 0
Worst scratching NRS questionnaires - Worst scratching NRS score as reported by the participant's caregiver
Timepoint [9] 0 0
Baseline to Month 60
Secondary outcome [10] 0 0
Caregiver Global Assessment of Disease (CGAD) questionnaire - CGAD score as reported by the participant's caregiver
Timepoint [10] 0 0
Baseline to Month 60
Secondary outcome [11] 0 0
Total Nasal Symptom Score (TNSS) questionnaire - TNSS score as reported by the participant's caregiver
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 - 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 - Number of visits to healthcare professionals for evaluation of healthcare utilization
Timepoint [13] 0 0
Baseline to Month 60
Secondary outcome [14] 0 0
Incidence of adverse events - Frequency of patients with at least one event, the number of events, and the incidence rate will be summarized by System Organ Class and Preferred Term
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
No limit
Maximum age
11 Years
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
investigational site AUSTRALIA - Australia
Recruitment postcode(s) [1] 0 0
- Australia
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Argentina
State/province [2] 0 0
Argentina
Country [3] 0 0
Brazil
State/province [3] 0 0
Brazil
Country [4] 0 0
Canada
State/province [4] 0 0
Canada
Country [5] 0 0
Colombia
State/province [5] 0 0
Colombia
Country [6] 0 0
Denmark
State/province [6] 0 0
Denmark
Country [7] 0 0
France
State/province [7] 0 0
France
Country [8] 0 0
Greece
State/province [8] 0 0
Greece
Country [9] 0 0
Israel
State/province [9] 0 0
Israel
Country [10] 0 0
Italy
State/province [10] 0 0
Italy
Country [11] 0 0
Japan
State/province [11] 0 0
Japan
Country [12] 0 0
Mexico
State/province [12] 0 0
Mexico
Country [13] 0 0
Netherlands
State/province [13] 0 0
Netherlands
Country [14] 0 0
Norway
State/province [14] 0 0
Norway
Country [15] 0 0
Portugal
State/province [15] 0 0
Portugal
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Russia
Country [17] 0 0
Spain
State/province [17] 0 0
Spain

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/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
Contact-US@sanofi.com
Contact person for scientific queries

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