This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment (NCT07290803) — China Trial Details

Condition(s) studied

Atopic Dermatitis

Study summary

The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions.

The study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.

Eligibility

Sex

ALL

Min age

12 Years

Max age

—

Healthy volunteers

No

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.

Primary outcome measure(s)

Number of Participants Utilizing Atopic Dermatitis (AD) Treatment — Baseline to up to 60 months
The number (and percentage) of participants taking AD treatments and treatments per patient will be described.
Duration of Treatment — Baseline to up to 60 months
The duration of AD treatments will be summarized descriptively.
AD Treatment Sequences — Baseline to up to 60 months
The ordering of AD treatments will be summarized descriptively.
Number of Participants Initiating AD Treatments with Reasons — Baseline 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 Treatment — Baseline 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 Treatment — Baseline 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 Treatments — Baseline 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 treatment — Baseline to up to 60 months
The number (and percentage) of patients augmenting AD treatment will be summarized descriptively.
Number of Participants Modifying AD Treatment Dose — Baseline 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 Baseline — Baseline 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 Baseline — Baseline 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 Baseline — Baseline 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 Baseline — Baseline 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 Baseline — Baseline 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 AD — Baseline to up to 60 months
Total remission of all signs and symptoms of AD will be assessed.

Trial sites (79)

Facility	City	Region	Status
Cahaba Dermatology & Skin Health Center- Site Number : 8400006	Birmingham	Alabama	Recruiting
River Region Dermatology and Laser- Site Number : 8400041	Montgomery	Alabama	Recruiting
San Tan Allergy & Asthma- Site Number : 8400031	Gilbert	Arizona	Recruiting
Saguaro Dermatology- Site Number : 8400028	Phoenix	Arizona	Recruiting
Kern Research, Inc.- Site Number : 8400047	Bakersfield	California	Recruiting
Center for Dermatology Clinical Research- Site Number : 8400014	Fremont	California	Recruiting
Dermatology Research Associates - Los Angeles- Site Number : 8400020	Los Angeles	California	Recruiting
Northridge Clinical Trials, LLC- Site Number : 8400009	Northridge	California	Recruiting
Sunwise Clinical Research, LLC.- Site Number : 8400010	Oakland	California	Recruiting
Empire Clinical Research, LLC- Site Number : 8400007	Pomona	California	Recruiting
University Clinical Trials- Site Number : 8400019	San Diego	California	Recruiting
Western States Clinical Research, Inc.- Site Number : 8400051	Wheat Ridge	Colorado	Recruiting
St. Jude Clinical Research- Site Number : 8400049	Doral	Florida	Recruiting
Ziaderm Research, LLC- Site Number : 8400021	North Miami Beach	Florida	Recruiting
Skin Care Physicians of Georgia - Macon- Site Number : 8400034	Macon	Georgia	Recruiting
Sneeze, Wheeze, & Itch Associates, LLC- Site Number : 8400029	Normal	Illinois	Recruiting
Rosalind Franklin University of Medicine and Science- Site Number: 8400056	North Chicago	Illinois	Recruiting
David Fivenson, MD, Dermatology, PLLC- Site Number : 8400017	Ann Arbor	Michigan	Recruiting
Oakland Hills Dermatology- Site Number : 8400042	Auburn Hills	Michigan	Recruiting
Great Lakes Research Group - Bay City- Site Number : 8400052	Bay City	Michigan	Recruiting
The Derm Institute of West Michigan- Site Number : 8400025	Caledonia	Michigan	Recruiting
Wayne State University - Detroit Medical Center- Site Number : 8400035	Detroit	Michigan	Recruiting
Michigan Dermatology Institute - Waterford- Site Number : 8400013	Waterford	Michigan	Recruiting
Red River Research Partners, Llc- Site Number : 8400054	Bolivar	Missouri	Recruiting
Cleaver Dermatology- Site Number : 8400033	Kirksville	Missouri	Recruiting
Allergy Asthma & Immunology- Site Number : 8400044	Lincoln	Nebraska	Recruiting
Las Vegas Dermatology- Site Number : 8400002	Las Vegas	Nevada	Recruiting
Optima Research Portsmouth- Site Number : 8400032	Portsmouth	New Hampshire	Recruiting
University Of New Mexico School Of Medicine- Site Number : 8400022	Albuquerque	New Mexico	Recruiting
Piedmont Plastic Surgery and Dermatology- Site Number : 8400038	Huntersville	North Carolina	Recruiting
Wake Forest University Health Sciences- Site Number : 8400003	Winston-Salem	North Carolina	Recruiting
Red River Research Partners - Fargo- Site Number : 8400037	Fargo	North Dakota	Recruiting
Dermatology Associates of Mid-Ohio- Site Number : 8400026	Marion	Ohio	Recruiting
Dermatologists of Southwest Ohio - Mason- Site Number : 8400050	Mason	Ohio	Recruiting
UPMC - Department of Dermatology- Site Number : 8400024	Pittsburgh	Pennsylvania	Recruiting
Care Access Research - Warwick 2- Site Number : 8400045	Warwick	Rhode Island	Recruiting
Advanced Dermatology and Cosmetic Surgery - Spartanburg- Site Number : 8400004	Spartanburg	South Carolina	Recruiting
Reveal Research Institute - Dallas- Site Number : 8400012	Dallas	Texas	Recruiting
Innovate Research - Fort Worth- Site Number : 8400016	Fort Worth	Texas	Recruiting
Austin Institute for Clinical Research, Inc- Site Number : 8400030	Pflugerville	Texas	Recruiting

+ 39 more sites — see the full list on the official registry below.

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