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

Purpose

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.

Condition

  • Atopic Dermatitis

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Atopic Dermatitis This study plans to collect information on adolescent and adult patients with atopic dermatitis who initiate or switch any systemic treatment (eg, biologics, oral Janus kinase [JAK] inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil) for AD according to the country-specific prescribing information. During the study, investigators will prescribe medical products for treatment of AD per standard of care (SoC) and per medical judgment.

Recruiting Locations

Cahaba Dermatology & Skin Health Center- Site Number : 8400006
Birmingham 4049979, Alabama 4829764 35244

Center for Dermatology Clinical Research- Site Number : 8400014
Fremont 5350734, California 5332921 94538

Dermatology Research Associates - Los Angeles- Site Number : 8400020
Los Angeles 5368361, California 5332921 90045

Sunwise Clinical Research, LLC.- Site Number : 8400010
Oakland 5378538, California 5332921 94596

Empire Clinical Research, LLC- Site Number : 8400007
Pomona 5384170, California 5332921 91767

Western States Clinical Research, Inc.- Site Number : 8400051
Wheat Ridge 5443948, Colorado 5417618 80033

St. Jude Clinical Research- Site Number : 8400049
Doral 4153471, Florida 4155751 33172
Contact:
Gustavo Torres
305-507-2273
gtorres@stjudeclinicalresearch.com

Skin Care Physicians of Georgia - Macon- Site Number : 8400034
Macon 4207400, Georgia 4197000 31217

Oakland Hills Dermatology- Site Number : 8400042
Auburn Hills 4984565, Michigan 5001836 48326

Michigan Dermatology Institute - Waterford- Site Number : 8400013
Waterford 5014130, Michigan 5001836 48328

Allergy Asthma & Immunology- Site Number : 8400044
Lincoln 5072006, Nebraska 5073708 68510

Las Vegas Dermatology- Site Number : 8400002
Las Vegas 5506956, Nevada 5509151 89144
Contact:
Harry Greenberg
702-456-3120
hlgreenberg@yahoo.com

Optima Research Portsmouth- Site Number : 8400032
Portsmouth 5091383, New Hampshire 5090174 03801
Contact:
Abel Jarell
603-441-1075
ajarell@stracskin.com

Red River Research Partners - Fargo- Site Number : 8400037
Fargo 5059163, North Dakota 5690763 58103

Advanced Dermatology and Cosmetic Surgery - Spartanburg- Site Number : 8400004
Spartanburg 4597200, South Carolina 4597040 29307

Complete Dermatology - Sugar Land- Site Number : 8400001
Sugar Land 4734825, Texas 4736286 77479

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
Contact-US@sanofi.com