Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients (PEDISTAD BIOMARKER STUDY)
- Conditions
- Dermatitis Atopic
- Registration Number
- NCT03849716
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To explore associations between biomarkers of atopic dermatitis (AD) and:
* Disease state and time course of AD,
* Disease state and evolution of selected atopic comorbid conditions,
* Effectiveness of specific AD treatments.
- Detailed Description
The estimated enrollment duration is approximately 2 years, while duration of observation is approximately 5 years.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 266
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biomarker identification: New presentation or resolution of atopic comorbidity Up to 5 years Identification of biomarkers associated with onset of a new atopic comorbidity or resolution of an existing atopic comorbidity
Biomarker identification: Demographics Baseline Identification of biomarkers associated with demographic characteristics
Biomarker evaluation: High versus low disease severity across participants Up to 5 years Examination of biomarker expression in participants with high disease severity versus those with low disease severity
Biomarker identification: Introduction of new systemic treatment Up to 5 years Identification of biomarkers associated with introduction of new systemic treatment
Biomarker identification: Response to systemic treatment Up to 5 years Identification of biomarkers associated with response to systemic treatment
Biomarker identification: Baseline disease characteristics Baseline Identification of biomarkers associated with disease characteristics at study entry (eg, disease severity, presence of other co-morbidities)
Biomarker identification: Changes in disease severity Up to 5 years Identification of biomarkers associated with disease severity increases/decreases (including remission) over time
Biomarker identification: Loss of response to systemic treatment Up to 5 years Identification of biomarkers associated with loss of response to systemic treatment
Biomarker evaluation: Start of systemic therapy early in life versus later in life Up to 5 years Examination of whether biomarker expression in participants who started systemic therapy for AD early in life (within 6 months) differs from those who started it later in life
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (48)
C Squared Research Center Site Number : 8400068
🇺🇸Birmingham, Alabama, United States
Cahaba Dermatology Site Number : 8400046
🇺🇸Birmingham, Alabama, United States
C2 Research Center, LLC Site Number : 8400071
🇺🇸Montgomery, Alabama, United States
Axis Clinical Trials Site Number : 8400025
🇺🇸Los Angeles, California, United States
Madera Family Medical Group Site Number : 8400054
🇺🇸Madera, California, United States
Fomat Medical Research, Inc. Site Number : 8400033
🇺🇸Oxnard, California, United States
Amedica Research Institute, Inc. Site Number : 8400067
🇺🇸Hialeah, Florida, United States
Eastern Research, Inc. Site Number : 8400032
🇺🇸Hialeah, Florida, United States
Vista Health Research, LLC Site Number : 8400034
🇺🇸Miami, Florida, United States
Pediatric & Adult Research Center Site Number : 8400040
🇺🇸Orlando, Florida, United States
Scroll for more (38 remaining)C Squared Research Center Site Number : 8400068🇺🇸Birmingham, Alabama, United States