Study in Paediatric Patients With Atopic Dermatitis Treated With Dupilumab in Spain (PROADAP)

Sanofi

Status: Enrolling

Conditions: Atopic Dermatitis

Treatments: Drug: Dupilumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06415175

OBS18427

U1111-1306-7579 (Registry Identifier)

Details and patient eligibility

About

This is a multicentre, prospective, non-interventional study that aims to describe the treatment patterns of in Atopic dermatitis (AD) patients aged 6 months to 11 years old in Spain: patients' characteristics, disease characteristics, prior treatments for and treatment prescription modalities. As well as to document the real-world effectiveness and safety of dupilumab during the two years of follow up. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied.

Enrollment: 150 estimated patients

Sex: All

Ages: 6 months to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged 6 months to 11 years old at baseline.
• Patients with severe Atopic dermatitis (AD) according to the investigator's assessment.
• Patients initiating dupilumab (in those patients initiated retrospectively 2 months before the start of the study, the baseline information must be correctly filled out in the medical records).
• Signed informed consent by the parent/legally acceptable representative and assent by the patient appropriate to the patient's age.

Exclusion criteria

• Patients who are participating in an interventional clinical trial that modifies patient care.

Trial design

150 participants in 1 patient group

Dupilumab

Description:

The information will be collected during consultation as part of the patient's usual follow-up.

Treatment:

Drug: Dupilumab