Understanding Atopic Dermatitis Treatment in the Real World

This study is a registry for adolescents and adults with atopic dermatitis (AD), a chronic skin condition. It aims to better understand the experiences of patients who are starting or switching any systemic treatment for their AD. Researchers will look at how long people use different treatments and the sequence of treatments over a period of up to five years. The study wants to learn about the challenges patients face, how their journey with AD unfolds, and how safe and effective treatments are in everyday life. You may be able to join if you are 12 years or older, have a confirmed diagnosis of AD, and are about to start a new systemic AD treatment.

Study design
This is an observational study, meaning researchers will collect information without giving specific treatments. It plans to include 1000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 60 months (5 years) to track their treatment use and outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07290803

This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment

Recruiting
Not specifiedAges 12+Observational
Sanofi
~1,000 participants
Updated 2026-08-06 on ClinicalTrials.gov

At a glance

Recruiting sites
79 of 79 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Utilizing Atopic Dermatitis (AD) Treatment
Measured over Baseline to up to 60 months
+18 more outcomes measured
Atopic Dermatitis
79 sites across 46 states
California7
Michigan6
Texas4
Italy4
Zhejiang3
Alabama2
Arizona2
Florida2
Trial Transparency email recommended (Toll free for US & Canada)
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Eligibility criteria

Inclusion

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

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.
  • Number of Participants Utilizing Atopic Dermatitis (AD) TreatmentBaseline to up to 60 months

    The number (and percentage) of participants taking AD treatments and treatments per patient will be described.

  • Duration of TreatmentBaseline to up to 60 months

    The duration of AD treatments will be summarized descriptively.

  • AD Treatment SequencesBaseline to up to 60 months

    The ordering of AD treatments will be summarized descriptively.

  • Number of Participants Initiating AD Treatments with ReasonsBaseline to up to 60 months

    The number (and percentage) of patients initiating AD treatment and reasons for initiation will be summarized descriptively.

  • Number of Participants Interrupting AD TreatmentBaseline to up to 60 months

    The number (and percentage) of patients interrupting AD treatment and reasons for treatment interruption will be summarized descriptively.

  • Number of Participants Discontinuing AD TreatmentBaseline to up to 60 months

    The number (and percentage) of patients discontinuing AD treatment and reasons for treatment discontinuation will be summarized descriptively.

  • Number of Participants Switching AD TreatmentsBaseline to up to 60 months

    The number (and percentage) of patients switching AD treatment and reasons for treatment switch will be summarized descriptively.

  • Number of Participants Augmenting AD treatmentBaseline to up to 60 months

    The number (and percentage) of patients augmenting AD treatment will be summarized descriptively.

  • Number of Participants Modifying AD Treatment DoseBaseline to up to 60 months

    The number (and percentage) of patients modifying AD treatment dose, reasons for dose modification, and dosing will be summarized descriptively.

  • Change from Baseline in Extent and Severity of AD Measured with Eczema Area and Severity Index (EASI)Baseline to up to 60 months

    Clinical outcomes measured using EASI will be summarized at the start of a treatment episode and each follow-up time point.

  • Change from Baseline in Extent and Severity of AD Measured with Body Surface Area (BSA)Baseline to up to 60 months

    Clinical outcomes measured using BSA will be summarized at the start of a treatment episode and each follow-up time point.

  • Change from Baseline in Extent and Severity of AD Measured with Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD)Baseline to up to 60 months

    Clinical outcomes measured using vIGA-AD will be summarized at the start of a treatment episode and each follow-up time point.

  • Change from Baseline in Extent and Severity of AD Measured with Revised Investigator's Global Assessment for Atopic Dermatitis (rIGA-AD)Baseline to up to 60 months

    Clinical outcomes measured using rIGA-AD will be summarized at the start of a treatment episode and each follow-up time point.

  • Change in Atopic Dermatitis Control Test (ADCT) from BaselineBaseline to up to 60 months

    The ADCT is a 6-item patient-reported outcomes instrument with a 7-day recall period to measure AD disease control. Total score ranges from 0 to 24.

  • Change in Patient Global Impression of Severity (PGIS) from BaselineBaseline to up to 60 months

    The PGIS is a single item tool used to assess current severity of eczema symptoms, scored on a 5-point scale from 1 = no symptoms to 5 = very severe symptoms.

  • Change in Itch severity as Measured with the Peak Pruritus Numeric Rating Scale (PP-NRS) from BaselineBaseline to up to 60 months

    The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.

  • Change in Skin Pain as Measured with Skin Pain Numeric Rating Scale (SP-NRS) from BaselineBaseline to up to 60 months

    The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD during the past 24 hours, with 0 = no pain and 10 = worst possible pain imaginable.

  • Change in Sleep Disturbance as Measured with Sleep Disturbance Numeric Rating Scale (SD-NRS) from BaselineBaseline to up to 60 months

    The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD, with 0 being 'no sleep loss related to the symptoms of atopic dermatitis' and 10 being 'I did not sleep at all' due to the symptoms of atopic dermatitis.

  • Remission of ADBaseline to up to 60 months

    Total remission of all signs and symptoms of AD will be assessed.