Clinical trial NCT06837454: French Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (AD)
Official title: French Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (AD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2025-02-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients participating in this study will be more than equal to (≥) 18 years old, managed in France for moderate to severe AD, and who are either eligible to systemic treatment or currently under systemic treatment, in realworldsettings within the inclusion period.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Previous and Current Treatments for Atopic Dermatitis (AD)
timeFrame: Baseline, month 6 and month 12
measure: Atopic Comorbidities: Previous and Current Therapeutic Management
timeFrame: Baseline, month 6 and month 12
measure: Change from Baseline in Drug Survival for Systemic Treatments for AD by Name and Dose
timeFrame: Baseline, month 6 and month 12
measure: Compliance for AD Treatments
timeFrame: Baseline, month 6 and month 12
Secondary outcomes:
measure: Demographic Characteristics of Participants
timeFrame: Baseline
measure: Medical History and AD history
timeFrame: Baseline
measure: Change from Baseline in AD Severity
timeFrame: Baseline, month 6 and month 12
measure: Atopic Comorbidities
timeFrame: Baseline, month 6 and month 12
measure: Non-atopic Comorbidities
timeFrame: Baseline, month 6 and month 12
measure: Use of Psychoactive Substances
timeFrame: Baseline, month 6 and month 12
measure: Change from Baseline in Itch Assessment
timeFrame: Baseline, month 6 and month 12
measure: Change from Baseline in Sleep Disturbance NRS
timeFrame: Baseline, month 6 and month 12
measure: Change from Baseline in Skin Pain NRS
timeFrame: Baseline, month 6 and month 12
measure: Change from Baseline in AD Disease Control Using the Atopic Dermatitis Control Tool (ADCT)
timeFrame: Baseline, month 6 and month 12
measure: Change from Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline, month 6 and month 12
measure: Change from Baseline in Psychological Comorbidities Assessed using Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, month 6 and month 12
measure: Cumulative Life Course Impairment (CLCI) - for Physicians in Hospital Centers
timeFrame: Baseline, month 6 and month 12
measure: Change from Baseline in Patient's Treatment Satisfaction Score Using the Patient Global Assessment of Treatment Effect (PGATE)
timeFrame: Baseline, month 6 and month 12
measure: Evolution of Atopic Comorbidities
timeFrame: Baseline, month 6 and month 12
measure: Management of AD from First Diagnosis
timeFrame: Baseline, month 6 and month 12
measure: Therapeutic Education
timeFrame: Baseline, month 6 and month 12
measure: Cost of Emollients and Hygiene Products
timeFrame: At month 12
measure: Sick Leaves Related to AD
timeFrame: Baseline, month 6 and month 12
measure: Hospitalization with Overnight Stay Related to AD
timeFrame: Baseline, month 6 and month 12
Other outcomes:
Locations:
city: Le Puy-en-Velay
country: France
facility: Investigational Site Number 00001
Study officials:
References: