This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment
Recruiting · NCT07290803 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sanofi
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
12 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
60 locations listed across 23 US states.
- Cahaba Dermatology & Skin Health Center- Site Number : 8400006 - Birmingham, Alabama, United States
- River Region Dermatology and Laser- Site Number : 8400041 - Montgomery, Alabama, United States
- San Tan Allergy & Asthma- Site Number : 8400031 - Gilbert, Arizona, United States
- Saguaro Dermatology- Site Number : 8400028 - Phoenix, Arizona, United States
- Kern Research, Inc.- Site Number : 8400047 - Bakersfield, California, United States
- Center for Dermatology Clinical Research- Site Number : 8400014 - Fremont, California, United States
- Dermatology Research Associates - Los Angeles- Site Number : 8400020 - Los Angeles, California, United States
- Northridge Clinical Trials, LLC- Site Number : 8400009 - Northridge, California, United States
- Sunwise Clinical Research, LLC.- Site Number : 8400010 - Oakland, California, United States
- Empire Clinical Research, LLC- Site Number : 8400007 - Pomona, California, United States
- University Clinical Trials- Site Number : 8400019 - San Diego, California, United States
- Western States Clinical Research, Inc.- Site Number : 8400051 - Wheat Ridge, Colorado, United States
- St. Jude Clinical Research- Site Number : 8400049 - Doral, Florida, United States
- Ziaderm Research, LLC- Site Number : 8400021 - North Miami Beach, Florida, United States
- Skin Care Physicians of Georgia - Macon- Site Number : 8400034 - Macon, Georgia, United States
- Sneeze, Wheeze, & Itch Associates, LLC- Site Number : 8400029 - Normal, Illinois, United States
- Rosalind Franklin University of Medicine and Science- Site Number: 8400056 - North Chicago, Illinois, United States
- David Fivenson, MD, Dermatology, PLLC- Site Number : 8400017 - Ann Arbor, Michigan, United States
- Oakland Hills Dermatology- Site Number : 8400042 - Auburn Hills, Michigan, United States
- Great Lakes Research Group - Bay City- Site Number : 8400052 - Bay City, Michigan, United States
- The Derm Institute of West Michigan- Site Number : 8400025 - Caledonia, Michigan, United States
- Wayne State University - Detroit Medical Center- Site Number : 8400035 - Detroit, Michigan, United States
- Michigan Dermatology Institute - Waterford- Site Number : 8400013 - Waterford, Michigan, United States
- Red River Research Partners, Llc- Site Number : 8400054 - Bolivar, Missouri, United States
- Cleaver Dermatology- Site Number : 8400033 - Kirksville, Missouri, United States
- Allergy Asthma & Immunology- Site Number : 8400044 - Lincoln, Nebraska, United States
- Las Vegas Dermatology- Site Number : 8400002 - Las Vegas, Nevada, United States
- Optima Research Portsmouth- Site Number : 8400032 - Portsmouth, New Hampshire, United States
- University Of New Mexico School Of Medicine- Site Number : 8400022 - Albuquerque, New Mexico, United States
- Piedmont Plastic Surgery and Dermatology- Site Number : 8400038 - Huntersville, North Carolina, United States
- Wake Forest University Health Sciences- Site Number : 8400003 - Winston-Salem, North Carolina, United States
- Red River Research Partners - Fargo- Site Number : 8400037 - Fargo, North Dakota, United States
- Dermatology Associates of Mid-Ohio- Site Number : 8400026 - Marion, Ohio, United States
- Dermatologists of Southwest Ohio - Mason- Site Number : 8400050 - Mason, Ohio, United States
- UPMC - Department of Dermatology- Site Number : 8400024 - Pittsburgh, Pennsylvania, United States
- Care Access Research - Warwick 2- Site Number : 8400045 - Warwick, Rhode Island, United States
- Advanced Dermatology and Cosmetic Surgery - Spartanburg- Site Number : 8400004 - Spartanburg, South Carolina, United States
- Reveal Research Institute - Dallas- Site Number : 8400012 - Dallas, Texas, United States
- Innovate Research - Fort Worth- Site Number : 8400016 - Fort Worth, Texas, United States
- Austin Institute for Clinical Research, Inc- Site Number : 8400030 - Pflugerville, Texas, United States
- Complete Dermatology - Sugar Land- Site Number : 8400001 - Sugar Land, Texas, United States
- Cope Family Medicine-Site Number : 8400053 - Bountiful, Utah, United States
- Springville Dermatology - Springville- Site Number : 8400055 - Springville, Utah, United States
- Fuchs Dermatology- Site Number : 8400027 - Falls Church, Virginia, United States
- Frontier Dermatology Partners CRO LLC- Site Number : 8400011 - Mill Creek, Washington, United States
- University of Washington - Roosevelt Location- Site Number : 8400005 - Seattle, Washington, United States
- Mediclinic Hospital, AUH-Site Number: 7840004 - Abu Dhabi, United Arab Emirates
- Dr Joseph Polyclinic Amber Clinic-Site Number: 7840005 - Al Karama, United Arab Emirates
- Hospital General Universitario Dr. Balmis-Site Number: 7240005 - Alicante, Spain
- Azienda Ospedaliero Universitaria delle Marche-Site Number: 3800009 - Ancona, Italy
- Investigational Site Number: 7240006 - Barcelona, Spain
- The First Affiliated Hospital of Chongqing Medical University-Site Number : 1560011 - Chongqing, China
- Ospedale Maggiore di Novara-Site Number: 3800005 - Novara, Italy
- Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia-Site Number : 3800006 - Reggio Emilia, Italy
- King Saud University-Site Number: 6820004 - Riyadh, Saudi Arabia
- King Fahad Medical City-Site Number : 6820001 - Riyadh, Saudi Arabia
- Istituto San Gallicano IRCCS - Istituti Fisioterapici Ospitalieri-Site Number: 3800002 - Roma, Italy
- Huashan Hospital, Fudan University-Site Number: 1560012 - Shanghai, China
- Peking University Third Hospital-Site Number: 1560008 - Beijing, Beijing Municipality, China
- CHU Besançon - Hôpital Jean Minjoz-Site Number: 2500010 - Besançon, Doubs, France
Showing 60 of 79 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →