Observational Evaluation of Atopic Dermatitis in Pediatric Patients

Study Overview
=================
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.

Detailed Description
-----------------
The study duration is 60 months.

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

Conditions
-----------------
Dermatitis Atopic

Intervention / Treatment
-----------------
* Other: Standard of care


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 11 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with atopic dermatitis (AD)<br>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<br>* Treatment as per standard practice<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics | Age, sex, race, ethnicity, body weight and height | Baseline | 
| Age at AD onset | Age of study patients at time of AD onset | Baseline | 
| Time from AD onset to initiation of therapy | Duration from onset of AD to start of AD therapy | Baseline | 
| Type of current AD therapy | Type of therapy administered to treat AD (e.g., systemic, topical, other) | Baseline | 
| 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 | Baseline to Month 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients using specific AD therapies and initiating new therapies | Percentage of patients using specific AD therapies and initiating new therapies | Baseline to Month 60 | 
| Eczema Area and Severity Index (EASI) | EASI score as assessed by physician | Baseline to Month 60 | 
| Body Surface Area (BSA) percentage affected by AD | BSA score as assessed by physician | Baseline to Month 60 | 
| Patient Oriented Eczema Measure (POEM) questionnaire | POEM score as reported by the participant's caregiver | Baseline to Month 60 | 
| Children's Dermatology Life Quality Index (CDLQI) | CDLQI score as reported by the participant | Baseline to Month 60 | 
| Infant's Dermatitis Quality of Life (IDQOL) | IDQOL score as reported by the participant's caregiver | Baseline to Month 60 | 
| Dermatitis Family Impact (DFI) questionnaires | DFI score as reported by the participant's caregiver | Baseline to Month 60 | 
| Peak Pruritus Numerical Rating Scale (NRS) | Peak Pruritus NRS score as reported by the participant | Baseline to Month 60 | 
| Worst scratching NRS questionnaires | Worst scratching NRS score as reported by the participant's caregiver | Baseline to Month 60 | 
| Caregiver Global Assessment of Disease (CGAD) questionnaire | CGAD score as reported by the participant's caregiver | Baseline to Month 60 | 
| Total Nasal Symptom Score (TNSS) questionnaire | TNSS score as reported by the participant's caregiver | Baseline to Month 60 | 
| 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 | Baseline to Month 60 | 
| Number of visits to healthcare professionals | Number of visits to healthcare professionals for evaluation of healthcare utilization | Baseline to Month 60 | 
| 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 | Baseline to Month 60 |