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

Sanofi

Status: Active, not recruiting

Conditions: Dermatitis Atopic

Treatments: Other: Blood sample; Other: Cheek swab

Study type: Observational

Funder types: Industry

Identifiers

NCT03849716

LPS15496

U1111-1207-8876 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 266 patients

Sex: All

Ages: Under 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

266 participants in 1 patient group

Participants with atopic dermatitis (AD)

Description:

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

Treatment:

Other: Cheek swab

Other: Blood sample