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.
The study duration is 120 months.
Study Type
OBSERVATIONAL
Enrollment
1,860
Treatment as per standard practice
Patient demographics
Time frame: Baseline (Month 0)
Medical history of selected atopic diseases and comorbidities
Time frame: Baseline (Month 0)
Age at onset of atopic dermatitis (AD)
Time frame: Baseline (Month 0)
Personal and family history of AD and selected atopic diseases
Time frame: Baseline (Month 0)
All prior and current systemic AD treatment
Time frame: Baseline (Month 0)
All prior and current topical therapy and phototherapy for AD (including dose, route and frequency of administration for all AD treatment)
Time frame: Baseline (Month 0)
Presence/severity of AD and selected atopic comorbid conditions
Time frame: Baseline to Month 120
Therapy for selected atopic comorbid conditions
Time frame: Baseline to Month 120
Days missed from school for the patient and days missed from work for the primary caregiver due to AD
Time frame: Baseline to Month 120
Visits to healthcare professionals (HCPs)
Time frame: Baseline to Month 120
Treatments and prescribing patterns for pediatric AD
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C Squared Research Center- Site Number : 8400068
Birmingham, Alabama, United States
Cahaba Dermatology & Skin Health Center- Site Number : 8400046
Birmingham, Alabama, United States
C2 Research Center, LLC- Site Number : 8400071
Montgomery, Alabama, United States
Phoenix Children's Hospital, Inc.- Site Number : 8400015
Phoenix, Arizona, United States
Orange County Research Institute- Site Number : 8400028
Anaheim, California, United States
Axis Clinical Trials- Site Number : 8400025
Los Angeles, California, United States
Madera Family Medical Group- Site Number : 8400054
Madera, California, United States
Carey Chronis, MD, FAAP- Site Number : 8400033
Ventura, California, United States
Daxia Trials- Site Number : 8400082
Boca Raton, Florida, United States
Frieder Dermatology- Site Number : 8400085
Boca Raton, Florida, United States
...and 172 more locations
Time frame: Baseline to Month 120
Changes in physician assessment of disease burden (Eczema Area and Severity Index [EASI])
Time frame: Baseline to Month 120
Changes in physician assessment of disease burden (Body Surface Area [BSA])
Time frame: Baseline to Month 120
Changes in patient/caregiver-reported outcome (PRO): Patient-Oriented Eczema Measure (POEM)
Time frame: Baseline to Month 120
Change in PRO: Children's Dermatology Life Quality Index (CDLQI)/ Infant's Dermatitis Quality of Life (IDQOL)
Time frame: Baseline to Month 120
Change in PRO: Dermatitis Family Impact (DFI)
Time frame: Baseline to Month 120
Change in PRO: Peak Pruritus Numerical Rating Scale (NRS)/ Pruritus (Itch) NRS/ Worst scratching NRS
Time frame: Baseline to Month 120
Change in PRO: Caregiver Global Assessment of Disease (CGAD)
Time frame: Baseline to Month 120
Change in PRO: Days missed from school for the patient and days missed from work for the primary caregiver due to AD since last visit
Time frame: Baseline to Month 120
Change in PRO: Total Nasal Symptom Score (TNSS)
Time frame: Baseline to Month 120
Change in PRO: Pediatric Asthma Questionnaire (PAQ)
Time frame: Baseline to Month 120
Change in PRO: Juniper Asthma Control Questionnaire-5 (ACQ-5)
Time frame: Baseline to Month 120
Adverse event (AE) reporting
Time frame: Baseline to Month 120