Tracking teens and adults with atopic dermatitis who start or change systemic treatment
Atopic Dermatitis Disease Registry of Adult and Adolescent Patients Initiating or Switching Systemic Treatments
This registry will follow people aged 12 and up with atopic dermatitis who start or switch systemic treatments to see how well the treatments work and how safe they are in everyday care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Drugs / interventions | methotrexate |
| Locations | 43 sites (Birmingham, Alabama and 42 other locations) |
| Trial ID | NCT07290803 on ClinicalTrials.gov |
What this trial studies
This prospective, non-interventional registry enrolls patients aged ≥12 with clinically diagnosed atopic dermatitis who are initiating or switching any systemic therapy. Participants are followed for up to five years across sites in 10 countries spanning four geographic regions, with regular clinic visits and data collection on treatments, flares, comorbidities, and adverse events. The study collects patient-specific factors such as age, skin color, trigger exposures, prior treatment responses, and lesion extent and location to map the real-world treatment journey. Data will be analyzed descriptively to characterize unmet needs, safety profiles, and clinical outcomes across diverse patient subgroups.
Who should consider this trial
Good fit: Ideal candidates are patients aged 12 or older with a confirmed diagnosis of atopic dermatitis who are about to start or change any systemic therapy and can provide informed consent (or assent with parental consent).
Not a fit: Patients who are not starting or switching systemic therapy, who are enrolled in interventional trials that alter their care, or who cannot complete long-term follow-up are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the registry could help doctors and patients choose systemic treatments that are safer and more effective for different types of people with atopic dermatitis.
How similar studies have performed: Similar prospective and registry studies in atopic dermatitis and biologic safety registries have previously provided useful long-term safety and effectiveness data, although fully global five-year registries remain relatively uncommon.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged more than or equal to (≥) 12 years at the time of consent. * Confirmed diagnosis of AD, of any severity, according to the Investigator's assessment as aligned with International Classification of Diseases 10th revision (ICD-10) code of L20. * Prescribed and scheduled to initiate any systemic treatment for AD (including but not limited to biologics, oral Janus kinase (JAK) inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil) * Signed informed consent for registry participation by the patient or parent/legal representative and assent by the patient appropriate to the patient's age, including willingness to participate in long-term follow-up. Exclusion Criteria: * Concurrent participation in an interventional clinical trial that administers an investigational drug that modifies patient care. * Insufficient understanding of the study by the patient and/or parent/guardian. 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
Birmingham, Alabama and 42 other locations
- Cahaba Dermatology & Skin Health Center- Site Number : 8400006 — Birmingham, Alabama, United States (Recruiting)
- River Region Dermatology and Laser- Site Number : 8400041 — Montgomery, Alabama, United States (Recruiting)
- San Tan Allergy & Asthma- Site Number : 8400031 — Gilbert, Arizona, United States (Recruiting)
- Kern Research, Inc.- Site Number : 8400047 — Bakersfield, California, United States (Recruiting)
- Center for Dermatology Clinical Research- Site Number : 8400014 — Fremont, California, United States (Recruiting)
- Dermatology Research Associates - Los Angeles- Site Number : 8400020 — Los Angeles, California, United States (Recruiting)
- Northridge Clinical Trials, LLC- Site Number : 8400009 — Northridge, California, United States (Recruiting)
- Sunwise Clinical Research, LLC.- Site Number : 8400010 — Oakland, California, United States (Recruiting)
- Empire Clinical Research, LLC- Site Number : 8400007 — Pomona, California, United States (Recruiting)
- University Clinical Trials- Site Number : 8400019 — San Diego, California, United States (Recruiting)
- Western States Clinical Research, Inc.- Site Number : 8400051 — Wheat Ridge, Colorado, United States (Recruiting)
- St. Jude Clinical Research- Site Number : 8400049 — Doral, Florida, United States (Recruiting)
- Ziaderm Research, LLC- Site Number : 8400021 — North Miami Beach, Florida, United States (Recruiting)
- Skin Care Physicians of Georgia - Macon- Site Number : 8400034 — Macon, Georgia, United States (Recruiting)
- Georgia Skin & Cancer Clinic- Site Number : 8400023 — Savannah, Georgia, United States (Recruiting)
- Rosalind Franklin University of Medicine and Science- Site Number: 8400056 — North Chicago, Illinois, United States (Recruiting)
- David Fivenson, MD, Dermatology, PLLC- Site Number : 8400017 — Ann Arbor, Michigan, United States (Recruiting)
- Oakland Hills Dermatology- Site Number : 8400042 — Auburn Hills, Michigan, United States (Recruiting)
- Great Lakes Research Group - Bay City- Site Number : 8400052 — Bay City, Michigan, United States (Recruiting)
- The Derm Institute of West Michigan- Site Number : 8400025 — Caledonia, Michigan, United States (Recruiting)
- Michigan Dermatology Institute - Waterford- Site Number : 8400013 — Waterford, Michigan, United States (Recruiting)
- Red River Research Partners, LLC- Site Number : 8400054 — Bolivar, Missouri, United States (Recruiting)
- Cleaver Dermatology- Site Number : 8400033 — Kirksville, Missouri, United States (Recruiting)
- Allergy Asthma & Immunology- Site Number : 8400044 — Lincoln, Nebraska, United States (Recruiting)
- Las Vegas Dermatology- Site Number : 8400002 — Las Vegas, Nevada, United States (Recruiting)
- Optima Research Portsmouth- Site Number : 8400032 — Portsmouth, New Hampshire, United States (Recruiting)
- Piedmont Plastic Surgery and Dermatology- Site Number : 8400038 — Huntersville, North Carolina, United States (Recruiting)
- Red River Research Partners - Fargo- Site Number : 8400037 — Fargo, North Dakota, United States (Recruiting)
- Dermatologists of Southwest Ohio - Mason- Site Number : 8400050 — Mason, Ohio, United States (Recruiting)
- Care Access Research - Warwick 2- Site Number : 8400045 — Warwick, Rhode Island, United States (Recruiting)
- Advanced Dermatology and Cosmetic Surgery - Spartanburg- Site Number : 8400004 — Spartanburg, South Carolina, United States (Recruiting)
- Reveal Research Institute - Dallas- Site Number : 8400012 — Dallas, Texas, United States (Recruiting)
- Innovate Research - Fort Worth- Site Number : 8400016 — Fort Worth, Texas, United States (Recruiting)
- Austin Institute for Clinical Research, Inc- Site Number : 8400030 — Pflugerville, Texas, United States (Recruiting)
- Complete Dermatology - Sugar Land- Site Number : 8400001 — Sugar Land, Texas, United States (Recruiting)
- Cope Family Medicine Ogden Clinic- Site Number : 8400053 — Bountiful, Utah, United States (Recruiting)
- Fuchs Dermatology- Site Number : 8400027 — Falls Church, Virginia, United States (Recruiting)
- Frontier Dermatology Partners CRO LLC- Site Number : 8400011 — Mill Creek, Washington, United States (Recruiting)
- Origins Dermatology Centre-Site Number : 1240003 — Regina, Saskatchewan, Canada (Recruiting)
- The First Affiliated Hospital of Ningbo University-Site Number : 1560009 — Ningbo, Zhejiang, China (Recruiting)
- GHRMSA - Hospital Emile Muller-Site Number : 2500006 — Mulhouse, Haut Rhin, France (Recruiting)
- Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia-Site Number : 3800006 — Reggio Emilia, Italy (Recruiting)
- King Fahad Medical City-Site Number : 6820001 — Riyadh, Saudi Arabia (Recruiting)
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.