Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Titles & IDs
Public title
Observational Evaluation of Atopic Dermatitis in Pediatric Patients
Query!
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
Query!
Secondary ID [1]
0
0
U1111-1211-9437
Query!
Secondary ID [2]
0
0
OBS15333
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PEDISTAD
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Dermatitis Atopic
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Observational [Patient Registry]
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Demographics
Query!
Assessment method [1]
0
0
Age, sex, race, ethnicity, body weight and height
Query!
Timepoint [1]
0
0
Baseline
Query!
Primary outcome [2]
0
0
Age at AD onset
Query!
Assessment method [2]
0
0
Age of study patients at time of AD onset
Query!
Timepoint [2]
0
0
Baseline
Query!
Primary outcome [3]
0
0
Time from AD onset to initiation of therapy
Query!
Assessment method [3]
0
0
Duration from onset of AD to start of AD therapy
Query!
Timepoint [3]
0
0
Baseline
Query!
Primary outcome [4]
0
0
Type of current AD therapy
Query!
Assessment method [4]
0
0
Type of therapy administered to treat AD (e.g., systemic, topical, other)
Query!
Timepoint [4]
0
0
Baseline
Query!
Primary outcome [5]
0
0
Presence of AD and selected comorbid conditions
Query!
Assessment method [5]
0
0
Percentage of patients with AD and selected comorbidities (e.g., asthma and allergic rhinitis) at baseline and during study
Query!
Timepoint [5]
0
0
Baseline to Month 60
Query!
Secondary outcome [1]
0
0
Percentage of patients using specific AD therapies and initiating new therapies
Query!
Assessment method [1]
0
0
Percentage of patients using specific AD therapies and initiating new therapies
Query!
Timepoint [1]
0
0
Baseline to Month 60
Query!
Secondary outcome [2]
0
0
Eczema Area and Severity Index (EASI)
Query!
Assessment method [2]
0
0
EASI score as assessed by physician
Query!
Timepoint [2]
0
0
Baseline to Month 60
Query!
Secondary outcome [3]
0
0
Body Surface Area (BSA) percentage affected by AD
Query!
Assessment method [3]
0
0
BSA score as assessed by physician
Query!
Timepoint [3]
0
0
Baseline to Month 60
Query!
Secondary outcome [4]
0
0
Patient Oriented Eczema Measure (POEM) questionnaire
Query!
Assessment method [4]
0
0
POEM score as reported by the participant's caregiver
Query!
Timepoint [4]
0
0
Baseline to Month 60
Query!
Secondary outcome [5]
0
0
Children's Dermatology Life Quality Index (CDLQI)
Query!
Assessment method [5]
0
0
CDLQI score as reported by the participant
Query!
Timepoint [5]
0
0
Baseline to Month 60
Query!
Secondary outcome [6]
0
0
Infant's Dermatitis Quality of Life (IDQOL)
Query!
Assessment method [6]
0
0
IDQOL score as reported by the participant's caregiver
Query!
Timepoint [6]
0
0
Baseline to Month 60
Query!
Secondary outcome [7]
0
0
Dermatitis Family Impact (DFI) questionnaires
Query!
Assessment method [7]
0
0
DFI score as reported by the participant's caregiver
Query!
Timepoint [7]
0
0
Baseline to Month 60
Query!
Secondary outcome [8]
0
0
Peak Pruritus Numerical Rating Scale (NRS)
Query!
Assessment method [8]
0
0
Peak Pruritus NRS score as reported by the participant
Query!
Timepoint [8]
0
0
Baseline to Month 60
Query!
Secondary outcome [9]
0
0
Worst scratching NRS questionnaires
Query!
Assessment method [9]
0
0
Worst scratching NRS score as reported by the participant's caregiver
Query!
Timepoint [9]
0
0
Baseline to Month 60
Query!
Secondary outcome [10]
0
0
Caregiver Global Assessment of Disease (CGAD) questionnaire
Query!
Assessment method [10]
0
0
CGAD score as reported by the participant's caregiver
Query!
Timepoint [10]
0
0
Baseline to Month 60
Query!
Secondary outcome [11]
0
0
Total Nasal Symptom Score (TNSS) questionnaire
Query!
Assessment method [11]
0
0
TNSS score as reported by the participant's caregiver
Query!
Timepoint [11]
0
0
Baseline to Month 60
Query!
Secondary outcome [12]
0
0
Days missed from school for the patient and days missed from work for the primary caregiver due to AD
Query!
Assessment method [12]
0
0
Days missed from school for the patient and days missed from work for the primary caregiver due to AD
Query!
Timepoint [12]
0
0
Baseline to Month 60
Query!
Secondary outcome [13]
0
0
Number of visits to healthcare professionals
Query!
Assessment method [13]
0
0
Number of visits to healthcare professionals for evaluation of healthcare utilization
Query!
Timepoint [13]
0
0
Baseline to Month 60
Query!
Secondary outcome [14]
0
0
Incidence of adverse events
Query!
Assessment method [14]
0
0
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
Query!
Timepoint [14]
0
0
Baseline to Month 60
Query!
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.
Query!
Minimum age
0
Years
Query!
Query!
Maximum age
11
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
15/08/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
21/04/2036
Query!
Actual
Query!
Sample size
Target
1856
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Query!
Recruitment hospital [1]
0
0
Investigational Site Number : 0360009 - Campbelltown
Query!
Recruitment hospital [2]
0
0
Investigational Site Number : 0360008 - Kogarah
Query!
Recruitment hospital [3]
0
0
Investigational Site Number : 0360001 - Westmead
Query!
Recruitment hospital [4]
0
0
Investigational Site Number : 0360010 - Box Hill
Query!
Recruitment hospital [5]
0
0
Investigational Site Number : 0360003 - Parkville
Query!
Recruitment hospital [6]
0
0
Investigational Site Number : 0360007 - Richmond
Query!
Recruitment hospital [7]
0
0
Investigational Site Number : 0360004 - Fremantle
Query!
Recruitment postcode(s) [1]
0
0
2560 - Campbelltown
Query!
Recruitment postcode(s) [2]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [3]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [4]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [5]
0
0
3052 - Parkville
Query!
Recruitment postcode(s) [6]
0
0
3121 - Richmond
Query!
Recruitment postcode(s) [7]
0
0
6160 - Fremantle
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kentucky
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Missouri
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nevada
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Jersey
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New York
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
North Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Ohio
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Oregon
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
South Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Wisconsin
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Buenos Aires
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Santa Fe
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
Ciudad Autonoma Bs As
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
Ciudad Autonoma Buenos Aires
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
San Miguel de Tucuman
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Paraná
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Rio Grande Do Sul
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
São Paulo
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Sorocaba
Query!
Country [31]
0
0
Canada
Query!
State/province [31]
0
0
Alberta
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
Manitoba
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Ontario
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Quebec
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Saskatchewan
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Beijing
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Changsha
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Chongqing
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Guangzhou
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Harbin
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Kunming
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Shenzhen
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Suzhou
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Xuzhou
Query!
Country [45]
0
0
Colombia
Query!
State/province [45]
0
0
Barranquilla
Query!
Country [46]
0
0
Colombia
Query!
State/province [46]
0
0
Bogota
Query!
Country [47]
0
0
Denmark
Query!
State/province [47]
0
0
Kobenhavn Nv
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Argenteuil Cedex
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Bordeaux
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Lille cedex
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Marseille cedex 5
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Martigues
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Nantes Cedex 1
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Paris Cedex 15
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Saint-Etienne Cedex 2
Query!
Country [56]
0
0
Greece
Query!
State/province [56]
0
0
Athens
Query!
Country [57]
0
0
Greece
Query!
State/province [57]
0
0
Larissa
Query!
Country [58]
0
0
Greece
Query!
State/province [58]
0
0
Thessaloniki
Query!
Country [59]
0
0
Israel
Query!
State/province [59]
0
0
Beer Sheva
Query!
Country [60]
0
0
Israel
Query!
State/province [60]
0
0
Haifa
Query!
Country [61]
0
0
Israel
Query!
State/province [61]
0
0
Kfar-Saba
Query!
Country [62]
0
0
Israel
Query!
State/province [62]
0
0
Ramat Gan
Query!
Country [63]
0
0
Israel
Query!
State/province [63]
0
0
Rehovot
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Latina
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Napoli
Query!
Country [66]
0
0
Italy
Query!
State/province [66]
0
0
Veneto
Query!
Country [67]
0
0
Italy
Query!
State/province [67]
0
0
Bari
Query!
Country [68]
0
0
Italy
Query!
State/province [68]
0
0
Bologna
Query!
Country [69]
0
0
Italy
Query!
State/province [69]
0
0
Catania
Query!
Country [70]
0
0
Italy
Query!
State/province [70]
0
0
Milano
Query!
Country [71]
0
0
Italy
Query!
State/province [71]
0
0
Padova
Query!
Country [72]
0
0
Italy
Query!
State/province [72]
0
0
Perugia
Query!
Country [73]
0
0
Italy
Query!
State/province [73]
0
0
Trieste
Query!
Country [74]
0
0
Japan
Query!
State/province [74]
0
0
Hiroshima
Query!
Country [75]
0
0
Japan
Query!
State/province [75]
0
0
Kanagawa
Query!
Country [76]
0
0
Japan
Query!
State/province [76]
0
0
Nagasaki
Query!
Country [77]
0
0
Japan
Query!
State/province [77]
0
0
Osaka-Fu
Query!
Country [78]
0
0
Japan
Query!
State/province [78]
0
0
Tokyo
Query!
Country [79]
0
0
Japan
Query!
State/province [79]
0
0
Fukuoka-shi
Query!
Country [80]
0
0
Japan
Query!
State/province [80]
0
0
Fukuyama-shi
Query!
Country [81]
0
0
Japan
Query!
State/province [81]
0
0
Kumagaya-shi
Query!
Country [82]
0
0
Japan
Query!
State/province [82]
0
0
Kyoto-shi
Query!
Country [83]
0
0
Japan
Query!
State/province [83]
0
0
Nagoya-shi
Query!
Country [84]
0
0
Japan
Query!
State/province [84]
0
0
Obu-shi
Query!
Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Osakasayama-shi
Query!
Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Sendai-shi
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Tsu-shi
Query!
Country [88]
0
0
Korea, Republic of
Query!
State/province [88]
0
0
Gyeonggi-do
Query!
Country [89]
0
0
Korea, Republic of
Query!
State/province [89]
0
0
Gyeongsangbuk-do
Query!
Country [90]
0
0
Korea, Republic of
Query!
State/province [90]
0
0
Seoul
Query!
Country [91]
0
0
Mexico
Query!
State/province [91]
0
0
Nuevo León
Query!
Country [92]
0
0
Mexico
Query!
State/province [92]
0
0
Mexico
Query!
Country [93]
0
0
Mexico
Query!
State/province [93]
0
0
Puebla
Query!
Country [94]
0
0
Mexico
Query!
State/province [94]
0
0
Tlalnepantla
Query!
Country [95]
0
0
Netherlands
Query!
State/province [95]
0
0
Amsterdam
Query!
Country [96]
0
0
Netherlands
Query!
State/province [96]
0
0
Den Haag
Query!
Country [97]
0
0
Netherlands
Query!
State/province [97]
0
0
Groningen
Query!
Country [98]
0
0
Netherlands
Query!
State/province [98]
0
0
Rotterdam
Query!
Country [99]
0
0
Netherlands
Query!
State/province [99]
0
0
Utrecht
Query!
Country [100]
0
0
Norway
Query!
State/province [100]
0
0
Bergen
Query!
Country [101]
0
0
Norway
Query!
State/province [101]
0
0
Oslo
Query!
Country [102]
0
0
Portugal
Query!
State/province [102]
0
0
Braga
Query!
Country [103]
0
0
Portugal
Query!
State/province [103]
0
0
Lisboa
Query!
Country [104]
0
0
Russian Federation
Query!
State/province [104]
0
0
Moscow
Query!
Country [105]
0
0
Spain
Query!
State/province [105]
0
0
Asturias
Query!
Country [106]
0
0
Spain
Query!
State/province [106]
0
0
Catalunya [Cataluña]
Query!
Country [107]
0
0
Spain
Query!
State/province [107]
0
0
Valencia
Query!
Country [108]
0
0
Spain
Query!
State/province [108]
0
0
Alicante
Query!
Country [109]
0
0
Spain
Query!
State/province [109]
0
0
Barcelona
Query!
Country [110]
0
0
Spain
Query!
State/province [110]
0
0
Madrid
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Sanofi
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03687359
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Sciences & Operations
Query!
Address
0
0
Sanofi
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Trial Transparency email recommended (Toll free number for US & Canada)
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
800-633-1610
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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