Observational study on systemic therapy for atopic dermatitis in adults
French Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (AD)
This study looks at how adults with moderate to severe atopic dermatitis are treated with systemic therapy in real-life settings over the course of a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 60 sites (Aix-en-Provence and 59 other locations) |
| Trial ID | NCT06837454 on ClinicalTrials.gov |
What this trial studies
This study aims to describe how patients aged 18 and older with moderate to severe atopic dermatitis are managed when eligible for systemic therapy. Conducted in real-world clinical settings, experienced dermatologists will make treatment decisions independently of the study enrollment. Patients will be followed for one year to assess their therapeutic management and outcomes. The study focuses on understanding the practical application of systemic treatments in everyday practice.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with moderate to severe atopic dermatitis who are eligible for or currently receiving systemic therapy.
Not a fit: Patients with conditions that may interfere with their ability to participate, such as severe cognitive impairment or those receiving systemic therapy for other diseases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effective management of atopic dermatitis, potentially leading to improved treatment strategies.
How similar studies have performed: While observational studies in atopic dermatitis exist, this specific approach focusing on real-world management and systemic therapy decisions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Where this trial is running
Aix-en-Provence and 59 other locations
- Investigational Site Number: 2500051 — Aix-en-Provence, France (Recruiting)
- Investigational Site Number: 2500023 — Amiens, France (Recruiting)
- Investigational Site Number: 2500004 — Angers, France (Recruiting)
- Investigational Site Number: 2500017 — Angers, France (Recruiting)
- Investigational Site Number: 2500050 — Arès, France (Recruiting)
- Investigational Site Number: 2500063 — Arès, France (Recruiting)
- Investigational Site Number: 2500054 — Bayonne, France (Recruiting)
- Investigational Site Number: 2500043 — Bezannes, France (Recruiting)
- Investigational Site Number: 2500040 — Biarritz, France (Recruiting)
- Investigational Site Number: 2500036 — Bordeaux, France (Recruiting)
- Investigational Site Number: 2500053 — Bordeaux, France (Recruiting)
- Investigational Site Number: 2500013 — Chalon-sur-Saône, France (Recruiting)
- Investigational Site Number: 2500026 — Chalon-sur-Saône, France (Recruiting)
- Investigational Site Number: 2500046 — Chalon-sur-Saône, France (Recruiting)
- Investigational Site Number: 2500041 — Châlons-en-Champagne, France (Recruiting)
- Investigational Site Number: 2500018 — Cherbourg, France (Recruiting)
- Investigational Site Number: 2500020 — Cholet, France (Recruiting)
- Investigational Site Number: 2500048 — Clermond Ferrand, France (Recruiting)
- Investigational Site Number: 2500059 — Contamine-sur-Arve, France (Recruiting)
- Investigational Site Number: 2500010 — Dunkirk, France (Recruiting)
- Investigational Site Number: 2500047 — Estrées-Deniécourt, France (Recruiting)
- Investigational Site Number: 2500049 — Fort-de-france, France (Recruiting)
- Investigational Site Number: 2500032 — La Ravoire, France (Recruiting)
- Investigational Site Number: 2500044 — La Ravoire, France (Recruiting)
- Investigational Site Number: 2500011 — La Roche-sur-Yon, France (Recruiting)
- Investigational Site Number: 2500037 — La Tronche, France (Recruiting)
- Investigational Site Number: 2500056 — Le Mans, France (Recruiting)
- Investigational Site Number: 2500068 — Le Mans, France (Recruiting)
- Investigational Site Number: 2500001 — Le Mans, France (Recruiting)
- Investigational Site Number: 2500012 — Le Puy-en-Velay, France (Recruiting)
- Investigational Site Number: 2500003 — Limoges, France (Recruiting)
- Investigational Site Number: 2500031 — Loperhet, France (Recruiting)
- Investigational Site Number: 2500060 — Marseille, France (Recruiting)
- Investigational Site Number: 2500055 — Monaco, France (Recruiting)
- Investigational Site Number: 2500058 — Mont-de-Marsan, France (Recruiting)
- Investigational Site Number: 2500070 — Mont-Saint-Aignan, France (Recruiting)
- Investigational Site Number: 2500033 — Niort, France (Recruiting)
- Investigational Site Number: 2500005 — Paris, France (Recruiting)
- Investigational Site Number: 2500030 — Paris, France (Recruiting)
- Investigational Site Number: 2500009 — Paris, France (Recruiting)
- Investigational Site Number: 2500028 — Périgueux, France (Recruiting)
- Investigational Site Number: 2500027 — Périgueux, France (Recruiting)
- Investigational Site Number: 2500029 — Rennes, France (Recruiting)
- Investigational Site Number: 2500035 — Rennes, France (Recruiting)
- Investigational Site Number: 2500021 — Romans-sur-Isère, France (Recruiting)
- Investigational Site Number: 2500022 — Rouen, France (Recruiting)
- Investigational Site Number: 2500025 — Saint-Etienne, France (Recruiting)
- Investigational Site Number: 2500062 — Saint-Gervais-les-Bains, France (Recruiting)
- Investigational Site Number: 2500076 — Saint-Martin, France (Recruiting)
- Investigational Site Number: 2500034 — Saint-Maur-des-Fossés, France (Recruiting)
+10 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.