Observational Evaluation of Atopic Dermatitis in Pediatric Patients
- Conditions
- Dermatitis Atopic
- Registration Number
- NCT03687359
- Lead Sponsor
- 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.
- Detailed Description
The study duration is 60 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1856
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient demographics Baseline (Month 0) Medical history of selected atopic diseases and comorbidities Baseline (Month 0) Age at onset of atopic dermatitis (AD) Baseline (Month 0) Personal and family history of AD and selected atopic diseases Baseline (Month 0) All prior and current systemic AD treatment Baseline (Month 0) All prior and current topical therapy and phototherapy for AD (including dose, route and frequency of administration for all AD treatment) Baseline (Month 0) Therapy for selected atopic comorbid conditions Baseline to Month 120 Presence/severity of AD and selected atopic comorbid conditions Baseline to Month 120
- Secondary Outcome Measures
Name Time Method Days missed from school for the patient and days missed from work for the primary caregiver due to AD Baseline to Month 120 Visits to healthcare professionals (HCPs) Baseline to Month 120 Treatments and prescribing patterns for pediatric AD Baseline to Month 120 Changes in physician assessment of disease burden (Eczema Area and Severity Index [EASI]) Baseline to Month 120 Changes in physician assessment of disease burden (Body Surface Area [BSA]) Baseline to Month 120 Changes in patient/caregiver-reported outcome (PRO): Patient-Oriented Eczema Measure (POEM) Baseline to Month 120 Change in PRO: Children's Dermatology Life Quality Index (CDLQI)/ Infant's Dermatitis Quality of Life (IDQOL) Baseline to Month 120 Change in PRO: Dermatitis Family Impact (DFI) Baseline to Month 120 Change in PRO: Peak Pruritus Numerical Rating Scale (NRS)/ Pruritus (Itch) NRS/ Worst scratching NRS Baseline to Month 120 Change in PRO: Caregiver Global Assessment of Disease (CGAD) 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 Baseline to Month 120 Change in PRO: Total Nasal Symptom Score (TNSS) Baseline to Month 120 Change in PRO: Pediatric Asthma Questionnaire (PAQ) Baseline to Month 120 Change in PRO: Juniper Asthma Control Questionnaire-5 (ACQ-5) Baseline to Month 120 Adverse event (AE) reporting Baseline to Month 120
Trial Locations
- Locations (181)
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
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