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OpenTrials
Completed

NCT Number: NCT03849716

Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients (PEDISTAD BIOMARKER STUDY)

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.

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Key information

Conditions

Dermatitis Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

0 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site Number : 0320006, Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

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About this study

The estimated enrollment duration is approximately 2 years, while duration of observation is approximately 5 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sample

Other

Blood samples obtained for biomarker analyses

Cheek swab

Other

Cheek swab obtained for genetic analysis

Primary outcomes

  1. Biomarker identification: Demographics

    Time frame: Baseline

    Identification of biomarkers associated with demographic characteristics

  2. Biomarker identification: Baseline disease characteristics

    Time frame: Baseline

    Identification of biomarkers associated with disease characteristics at study entry (eg, disease severity, presence of other co-morbidities)

  3. Biomarker identification: Changes in disease severity

    Time frame: Up to 5 years

    Identification of biomarkers associated with disease severity increases/decreases (including remission) over time

  4. Biomarker evaluation: High versus low disease severity across participants

    Time frame: Up to 5 years

    Examination of biomarker expression in participants with high disease severity versus those with low disease severity

  5. Biomarker identification: New presentation or resolution of atopic comorbidity

    Time frame: Up to 5 years

    Identification of biomarkers associated with onset of a new atopic comorbidity or resolution of an existing atopic comorbidity

  6. Biomarker identification: Introduction of new systemic treatment

    Time frame: Up to 5 years

    Identification of biomarkers associated with introduction of new systemic treatment

  7. Biomarker identification: Response to systemic treatment

    Time frame: Up to 5 years

    Identification of biomarkers associated with response to systemic treatment

  8. Biomarker identification: Loss of response to systemic treatment

    Time frame: Up to 5 years

    Identification of biomarkers associated with loss of response to systemic treatment

  9. Biomarker evaluation: Start of systemic therapy early in life versus later in life

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2019
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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