French Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (AD) (FRAME)

Sanofi

Status: Enrolling

Conditions: Atopic Dermatitis

Study type: Observational

Funder types: Industry

Identifiers

NCT06837454

U1111-1279-3382 (Registry Identifier)

OBS17667

Details and patient eligibility

About

The objective of the study is to describe the therapeutic management of patients more than or equal to 18 years old eligible for systemic therapy or treated by systemic therapy for atopic dermatitis (AD). This study will be proposed to a sample of French dermatologists experienced in the management of AD, practicing in hospital centers and/or office-based dermatologists. The study will be conducted in real conditions of practice, systemic treatment decisions will be taken at the sole initiative of the participating physician irrespective of the patient enrollment decision. Each patient will be followed-up in routine care setting for 1 year.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent form.

• Patient with moderate to severe AD according to the Investigator's judgment and

  1. Patient eligible to systemic treatment as Atopic Dermatitis Control Tool (ADCT) more than or equal to (≥) 7 and/or use topical corticosteroids (TCS) more than (>) 90 gram (g)/month and/or TCS are not advisable.

     or

  2. Patient currently under systemic treatment.

• Able to understand and complete study-related questionnaires.

Exclusion criteria

• Any condition that, in the opinion of the Investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from adequately completing, as per routine care, the schedule of visits and assessments
• Patient receiving systemic therapy only for a disease other than AD.
• Patient participating in any interventional clinical trial at the time of enrolment.
• Patient is under tutorship or curatorship; patient under safeguard of justice or deprived of his/her liberty by an administrative or court decision

Trial design

600 participants in 1 patient group

Atopic Dermatitis

Description:

The study plans to collect information on patients during visits according to clinical practice. Enrolled patients will receive AD treatment of marketed drugs prescribed by the specialty physician. No investigational drug will be given for the purpose of this study.