Dermatitis Atopic
Conditions
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.
Interventions
OTHERBlood sample
Blood samples obtained for biomarker analyses
OTHERCheek swab
Cheek swab obtained for genetic analysis
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Participation in the OBS15333 pediatric atopic dermatitis (AD) registry. * Signed informed consent by the parent/legally acceptable representative and assent by the participant appropriate to the participant's age.
Exclusion criteria
Not applicable. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker identification: Demographics | Baseline | Identification of biomarkers associated with demographic characteristics |
| 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 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: 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: 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: 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 |
Countries
Argentina, Australia, Brazil, Canada, Colombia, France, Mexico, Netherlands, United States
Contacts
STUDY_DIRECTORClinical Sciences & Operations
Sanofi
Outcome results
None listed