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.
This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment
At a glance
Conditions
Where it's being run
79 sites across 46 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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.