Ireland
--:--IST
Active, not recruiting Observational

Observational Evaluation of Atopic Dermatitis in Pediatric Patients

NCT03687359 · tracked via the Priya Life Science South Korea tracker
Sponsor
Phase
Observational
Started
2019-08-15
Last updated
2025-08-15

Condition(s) studied

Dermatitis Atopic

Investigational drug(s) / intervention(s)

Standard of care

Standard of care: Treatment as per standard practice

Study 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.

Eligibility

Sex
ALL
Min age
0 Years
Max age
11 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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)
  • Presence/severity of AD and selected atopic comorbid conditions — Baseline to Month 120
  • Therapy for selected atopic comorbid conditions — Baseline to Month 120

Trial sites (182)

FacilityCityRegionStatus
C Squared Research Center- Site Number : 8400068 Birmingham Alabama
Cahaba Dermatology & Skin Health Center- Site Number : 8400046 Birmingham Alabama
C2 Research Center, LLC- Site Number : 8400071 Montgomery Alabama
Phoenix Children's Hospital, Inc.- Site Number : 8400015 Phoenix Arizona
Orange County Research Institute- Site Number : 8400028 Anaheim California
Axis Clinical Trials- Site Number : 8400025 Los Angeles California
Madera Family Medical Group- Site Number : 8400054 Madera California
Carey Chronis, MD, FAAP- Site Number : 8400033 Ventura California
Daxia Trials- Site Number : 8400082 Boca Raton Florida
Frieder Dermatology- Site Number : 8400085 Boca Raton Florida
Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology, LLC- Site Number : 8400072 Coral Gables Florida
Green Dermatology and Cosmetic Center. Site Number : 8400078 Deerfield Beach Florida
Amedica Research Institute, Inc.- Site Number : 8400067 Hialeah Florida
Eastern Research, Inc.- Site Number : 8400032 Hialeah Florida
Premier Dermatology Partners- Site Number : 8400075 Miami Florida
Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400074 Miami Florida
Vista Health Research, LLC- Site Number : 8400034 Miami Florida
Pediatric & Adult Research Center- Site Number : 8400040 Orlando Florida
Elias Dermatology LLC- Site Number : 8400086 Pembroke Pines Florida
Elias Dermatology LLC- Site Number : 8400087 Pembroke Pines Florida
Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400056 Columbus Georgia
Northwestern University Feinberg School of Medicine- Site Number : 8400001 Chicago Illinois
NorthShore University HealthSystem - Skokie- Site Number : 8400064 Skokie Illinois
The Indiana Clinical Trial Center - Plainfield - Edwards Drive- Site Number : 8400007 Plainfield Indiana
The Indiana Clinical Trials Center, PC Site Number : 8400007 Plainfield Indiana
Michael W. Simon, M.D., PSC- Site Number : 8400073 Lexington Kentucky
Dermatology Associates PC- Site Number : 8400049 Rockville Maryland
Michigan Dermatology Institute Site Number : 8400059 Waterford Michigan
Tokunbo T. Dada, MD PA- Site Number : 8400079 Irvington New Jersey
Family Pediatrics Iwuozo L Obilo Md- Site Number : 8400077 Newark New Jersey
Providence Medical Center- Site Number : 8400081 North Plainfield New Jersey
VAMA Medical Health Center- Site Number : 8400083 Union New Jersey
Park Plaza Dermatology- Site Number : 8400080 New York New York
Philip Fried, M.D., PLLC- Site Number : 8400029 The Bronx New York
Tiga Pediatrics, PC- Site Number : 8400037 The Bronx New York
UNC Hospitals- Site Number : 8400016 Chapel Hill North Carolina
2G Clinical Research Services- Site Number : 8400031 Durham North Carolina
Clinical Research Of Gastonia- Site Number : 8400041 Gastonia North Carolina
Cincinnati Children's Hospital Medical Center- Site Number : 8400017 Cincinnati Ohio
Dermatology Associates of Mid-Ohio- Site Number : 8400052 Marion Ohio

+ 142 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03687359 on ClinicalTrials.gov ↗ ← All trials in South Korea