French Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (AD)
FRAME
2 other identifiers
observational
600
1 country
62
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Typical duration for all trials
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2025
CompletedStudy Start
First participant enrolled
February 4, 2025
CompletedFirst Posted
Study publicly available on registry
February 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 13, 2027
May 20, 2026
May 1, 2026
2.3 years
January 28, 2025
May 19, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Previous and Current Treatments for Atopic Dermatitis (AD)
List of previous and current treatments for AD based on physician-reported data will be assessed.
Baseline, month 6 and month 12
Atopic Comorbidities: Previous and Current Therapeutic Management
Description of previous and current therapeutic management of atopic comorbidities over time based on physician-reported data will be assessed.
Baseline, month 6 and month 12
Change from Baseline in Drug Survival for Systemic Treatments for AD by Name and Dose
Drug survival is defined as the time from the start of treatment to the end or discontinuation of treatment with no changes. If a patient has multiple drug survival events for the same treatment, the longest drug survival will be used in the data summarization. The drug survival will be illustrated using a Kaplan-Meier plot.
Baseline, month 6 and month 12
Compliance for AD Treatments
Compliance for AD treatments will be assessed by the physician.
Baseline, month 6 and month 12
Secondary Outcomes (20)
Demographic Characteristics of Participants
Baseline
Medical History and AD history
Baseline
Change from Baseline in AD Severity
Baseline, month 6 and month 12
Atopic Comorbidities
Baseline, month 6 and month 12
Non-atopic Comorbidities
Baseline, month 6 and month 12
- +15 more secondary outcomes
Study Arms (1)
Atopic Dermatitis
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.
Eligibility Criteria
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.
You may qualify if:
- Signed informed consent form.
- Patient with moderate to severe AD according to the Investigator's judgment and
- 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.
- Patient currently under systemic treatment.
- Able to understand and complete study-related questionnaires.
You may not qualify if:
- 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
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (62)
Investigational Site Number: 2500051
Aix-en-Provence, 13100, France
Investigational Site Number: 2500023
Amiens, 80000, France
Investigational Site Number: 2500004
Angers, 49000, France
Investigational Site Number: 2500017
Angers, 49100, France
Investigational Site Number: 2500050
Arès, 33740, France
Investigational Site Number: 2500063
Arès, 33740, France
Investigational Site Number: 2500054
Bayonne, 64100, France
Investigational Site Number: 2500043
Bezannes, 51430, France
Investigational Site Number: 2500040
Biarritz, 64200, France
Investigational Site Number: 2500036
Bordeaux, 33000, France
Investigational Site Number: 2500053
Bordeaux, 33000, France
Investigational Site Number: 2500013
Chalon-sur-Saône, 71100, France
Investigational Site Number: 2500026
Chalon-sur-Saône, 71100, France
Investigational Site Number: 2500046
Chalon-sur-Saône, 71100, France
Investigational Site Number: 2500041
Châlons-en-Champagne, 51005, France
Investigational Site Number: 2500018
Cherbourg, 50102, France
Investigational Site Number: 2500020
Cholet, 49300, France
Investigational Site Number: 2500048
Clermond Ferrand, 63003, France
Investigational Site Number: 2500059
Contamine-sur-Arve, 74130, France
Investigational Site Number: 2500010
Dunkirk, 59385, France
Investigational Site Number: 2500047
Estrées-Deniécourt, 80200, France
Investigational Site Number: 2500049
Fort-de-france, 97261, France
Investigational Site Number: 2500032
La Ravoire, 73490, France
Investigational Site Number: 2500044
La Ravoire, 73490, France
Investigational Site Number: 2500011
La Roche-sur-Yon, 85925, France
Investigational Site Number: 2500037
La Tronche, 38700, France
Investigational Site Number: 2500056
Le Mans, 72000, France
Investigational Site Number: 2500068
Le Mans, 72000, France
Investigational Site Number: 2500001
Le Mans, 72037, France
Investigational Site Number: 2500012
Le Puy-en-Velay, 43000, France
Investigational Site Number: 2500003
Limoges, 87042, France
Investigational Site Number: 2500031
Loperhet, 29470, France
Investigational Site Number: 2500060
Marseille, 13012, France
Investigational Site Number: 2500055
Monaco, 98000, France
Investigational Site Number: 2500058
Mont-de-Marsan, 40024, France
Investigational Site Number: 2500070
Mont-Saint-Aignan, 76140, France
Investigational Site Number: 2500033
Niort, 79021, France
Investigational Site Number: 2500065
Paris, 75005, France
Investigational Site Number: 2500005
Paris, 75009, France
Investigational Site Number: 2500030
Paris, 75010, France
Investigational Site Number: 2500071
Paris, 75017, France
Investigational Site Number: 2500009
Paris, 75020, France
Investigational Site Number: 2500028
Périgueux, 24000, France
Investigational Site Number: 2500027
Périgueux, 24019, France
Investigational Site Number: 2500029
Rennes, 35000, France
Investigational Site Number: 2500035
Rennes, 35000, France
Investigational Site Number: 2500021
Romans-sur-Isère, 26102, France
Investigational Site Number: 2500022
Rouen, 76031, France
Investigational Site Number: 2500025
Saint-Etienne, 42100, France
Investigational Site Number: 2500062
Saint-Gervais-les-Bains, 74170, France
Investigational Site Number: 2500076
Saint-Martin, 97150, France
Investigational Site Number: 2500034
Saint-Maur-des-Fossés, 94100, France
Investigational Site Number: 2500008
Saint-Maur-dès-Faussés, 94100, France
Investigational Site Number: 2500045
Saint-Quentin, 02321, France
Investigational Site Number: 2500057
Sainte-Eulalie, 15140, France
Investigational Site Number: 2500019
Sainte-Maxime, 83120, France
Investigational Site Number: 2500015
Toulouse, 31200, France
Investigational Site Number: 2500016
Tours, 37044, France
Investigational Site Number: 2500038
Vannes, 56000, France
Investigational Site Number: 2500024
Villefranche-sur-Saône, 69655, France
Investigational Site Number: 2500052
Villeurbanne, 69100, France
Investigational Site Number: 2500066
Villeurbanne, 69100, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2025
First Posted
February 20, 2025
Study Start
February 4, 2025
Primary Completion (Estimated)
May 13, 2027
Study Completion (Estimated)
May 13, 2027
Last Updated
May 20, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org