Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients (PEDISTAD BIOMARKER STUDY)
- Conditions
- Dermatitis Atopic
- Interventions
- Other: Blood sampleOther: Cheek swab
- 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
- Arm && Interventions
Group Intervention Description Participants with atopic dermatitis (AD) Blood sample Participants included in observational study OBS15333 (atopic dermatitis pediatric registry) who consent to enter this companion study LPS15496. Participants receive AD therapy as part of their usual care as determined by their physician independent of decision to enter either protocol, and neither protocol OBS15333 nor LPS15496 specifies assignment of any drug intervention Participants with atopic dermatitis (AD) Cheek swab Participants included in observational study OBS15333 (atopic dermatitis pediatric registry) who consent to enter this companion study LPS15496. Participants receive AD therapy as part of their usual care as determined by their physician independent of decision to enter either protocol, and neither protocol OBS15333 nor LPS15496 specifies assignment of any drug intervention
- 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)
Investigational Site Number : 2500003
🇫🇷Paris Cedex 15, France
Investigational Site Number : 4840006
🇲🇽Mexico, Mexico
Investigational Site Number : 5280005
🇳🇱Groningen, Netherlands
Investigational Site Number : 5280003
🇳🇱Utrecht, Netherlands
Eastern Research, Inc. Site Number : 8400032
🇺🇸Hialeah, Florida, United States
Northwestern University Feinberg School of Medicine Site Number : 8400001
🇺🇸Chicago, Illinois, United States
Investigational Site Number : 1240008
🇨🇦Toronto, Ontario, Canada
NorthShore University HealthSystem Site Number : 8400064
🇺🇸Skokie, Illinois, United States
Cincinnati Children's Hospital Medical Center Site Number : 8400017
🇺🇸Cincinnati, Ohio, United States
Axis Clinical Trials Site Number : 8400025
🇺🇸Los Angeles, California, United States
Amedica Research Institute, Inc. Site Number : 8400067
🇺🇸Hialeah, Florida, United States
Vista Health Research, LLC Site Number : 8400034
🇺🇸Miami, Florida, United States
Madera Family Medical Group Site Number : 8400054
🇺🇸Madera, California, United States
Heights Dermatology and Aesthetic Center Site Number : 8400065
🇺🇸Houston, Texas, United States
Investigational Site Number : 4840003
🇲🇽Monterrey, Nuevo León, Mexico
Investigational Site Number : 0320002
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Investigational Site Number : 0320006
🇦🇷Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Investigational Site Number : 4840005
🇲🇽Tlalnepantla, Mexico
Investigational Site Number : 0320004
🇦🇷Rosario, Santa Fe, Argentina
Investigational Site Number : 0360003
🇦🇺Melbourne, Victoria, Australia
Universidade Federal do Paraná Site Number : 0760003
🇧🇷Curitiba, Paraná, Brazil
Investigational Site Number : 1700001
🇨🇴Bogota, Colombia
HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760004
🇧🇷Curitiba, Paraná, Brazil
Hospital Sao Paulo Site Number : 0760006
🇧🇷São Paulo, São Paulo, Brazil
Cahaba Dermatology Site Number : 8400046
🇺🇸Birmingham, Alabama, United States
IACT Health Site Number : 8400056
🇺🇸Columbus, Georgia, United States
C Squared Research Center Site Number : 8400068
🇺🇸Birmingham, Alabama, United States
C2 Research Center, LLC Site Number : 8400071
🇺🇸Montgomery, Alabama, United States
Fomat Medical Research, Inc. Site Number : 8400033
🇺🇸Oxnard, California, United States
Amarillo Center for Clinical Research Site Number : 8400055
🇺🇸Amarillo, Texas, United States
Allergic Disease and Asthma Research Center, PA Site Number : 8400048
🇺🇸Greenville, South Carolina, United States
Dermatology Associates of Mid-Ohio Site Number : 8400052
🇺🇸Marion, Ohio, United States
Investigational Site Number : 0360001
🇦🇺Westmead, New South Wales, Australia
Investigational Site Number : 0320001
🇦🇷Ciudad Autonoma Bs As, Argentina
Investigational Site Number : 0320003
🇦🇷Buenos Aires, Argentina
Irmandade da Santa Casa de Misericórdia de Porto Alegre Site Number : 0760002
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Clínica de Alergia Martti Antila Site Number : 0760001
🇧🇷Sorocaba, Brazil
Investigational Site Number : 1240005
🇨🇦Winnipeg, Manitoba, Canada
Investigational Site Number : 1240007
🇨🇦Calgary, Alberta, Canada
Investigational Site Number : 1700004
🇨🇴Bogota, Colombia
Investigational Site Number : 1240006
🇨🇦Montreal, Quebec, Canada
Investigational Site Number : 2500006
🇫🇷Marseille cedex 5, France
Georgia Pollens Clinical Research Centers, Inc. Site Number : 8400057
🇺🇸Albany, Georgia, United States
Pediatric & Adult Research Center Site Number : 8400040
🇺🇸Orlando, Florida, United States
MUSC Site Number : 8400013
🇺🇸Charleston, South Carolina, United States
Philip Fried, M.D., PLLC Site Number : 8400029
🇺🇸Bronx, New York, United States
Tiga Pediatrics, PC Site Number : 8400037
🇺🇸Bronx, New York, United States
HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760005
🇧🇷Curitiba, Paraná, Brazil