Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Observational Evaluation of Atopic Dermatitis in Pediatric Patients (PEDISTAD)

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03687359
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment
Dermatitis Atopic Other: Standard of care

Detailed Description:
The study duration is 60 months.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official 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
Actual Study Start Date : September 21, 2018
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Group/Cohort Intervention/treatment
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: Standard of care
Treatment as per standard practice




Primary Outcome Measures :
  1. Demographics [ Time Frame: Baseline ]
    Age, sex, race, ethnicity, body weight and height

  2. Age at AD onset [ Time Frame: Baseline ]
    Age of study patients at time of AD onset

  3. Time from AD onset to initiation of therapy [ Time Frame: Baseline ]
    Duration from onset of AD to start of AD therapy

  4. Type of current AD therapy [ Time Frame: Baseline ]
    Type of therapy administered to treat AD (e.g., systemic, topical, other)

  5. Presence of AD and selected comorbid conditions [ Time Frame: Baseline to Month 60 ]
    Percentage of patients with AD and selected comorbidities (e.g., asthma and allergic rhinitis) at baseline and during study


Secondary Outcome Measures :
  1. Percentage of patients using specific AD therapies and initiating new therapies [ Time Frame: Baseline to Month 60 ]
    Percentage of patients using specific AD therapies and initiating new therapies

  2. Eczema Area and Severity Index (EASI) [ Time Frame: Baseline to Month 60 ]
    EASI score as assessed by physician

  3. Body Surface Area (BSA) percentage affected by AD [ Time Frame: Baseline to Month 60 ]
    BSA score as assessed by physician

  4. Patient Oriented Eczema Measure (POEM) questionnaire [ Time Frame: Baseline to Month 60 ]
    POEM score as reported by the participant's caregiver

  5. Children's Dermatology Life Quality Index (CDLQI) [ Time Frame: Baseline to Month 60 ]
    CDLQI score as reported by the participant

  6. Infant's Dermatitis Quality of Life (IDQOL) [ Time Frame: Baseline to Month 60 ]
    IDQOL score as reported by the participant's caregiver

  7. Dermatitis Family Impact (DFI) questionnaires [ Time Frame: Baseline to Month 60 ]
    DFI score as reported by the participant's caregiver

  8. Peak Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline to Month 60 ]
    Peak Pruritus NRS score as reported by the participant

  9. Worst scratching NRS questionnaires [ Time Frame: Baseline to Month 60 ]
    Worst scratching NRS score as reported by the participant's caregiver

  10. Caregiver Global Assessment of Disease (CGAD) questionnaire [ Time Frame: Baseline to Month 60 ]
    CGAD score as reported by the participant's caregiver

  11. Total Nasal Symptom Score (TNSS) questionnaire [ Time Frame: Baseline to Month 60 ]
    TNSS score as reported by the participant's caregiver

  12. Days missed from school for the patient and days missed from work for the primary caregiver due to AD [ Time Frame: Baseline to Month 60 ]
    Days missed from school for the patient and days missed from work for the primary caregiver due to AD

  13. Number of visits to healthcare professionals [ Time Frame: Baseline to Month 60 ]
    Number of visits to healthcare professionals for evaluation of healthcare utilization

  14. Incidence of adverse events [ Time Frame: Baseline to Month 60 ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pediatric patients with moderate to severe AD whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable.
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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687359


Contacts
Layout table for location contacts
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

Locations
Layout table for location information
United States, Texas
Investigational site USA Recruiting
Grapevine, Texas, United States, 76051
Argentina
investigational site Argentina Recruiting
Argentina, Argentina
Brazil
investigational site Brazil Recruiting
Brazil, Brazil
Canada
Investigational site Canada Recruiting
Canada, Canada
Colombia
investigational site Colombia Recruiting
Colombia, Colombia
Denmark
investigational site Denmark Recruiting
Denmark, Denmark
France
investigational site France Recruiting
France, France
Greece
Investigational site Greece Recruiting
Greece, Greece
Israel
investigational site Israel Recruiting
Israel, Israel
Italy
investigational site Italy Recruiting
Italy, Italy
Japan
investigational site Japan Recruiting
Japan, Japan
Mexico
Investigational site Mexico Recruiting
Mexico, Mexico
Netherlands
Investigational site Netherlands Recruiting
Netherlands, Netherlands
Norway
investigational site Norway Recruiting
Norway, Norway
Portugal
Investigational site Portugal Recruiting
Portugal, Portugal
Spain
investigational site Spain Recruiting
Spain, Spain
Sponsors and Collaborators
Sanofi
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi

Additional Information:

Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03687359    
Other Study ID Numbers: OBS15333
U1111-1211-9437 ( Other Identifier: UTN )
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases