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

Observational Sanofi · NCT07290803

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 typeObservational
Enrollment1000 (estimated)
Ages12 Years and up
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsmethotrexate
Locations43 sites (Birmingham, Alabama and 42 other locations)
Trial IDNCT07290803 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

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Atopic Dermatitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.