Denne undersøgelse er et ikke-interventionelt sygdomsregister for unge og voksne patienter med atopisk dermatitis, som påbegynder eller skifter systemisk behandling (ARMADA-AD)
Atopisk Dermatitis Sygdomsregister for Voksne og Unge Patienter, der Påbegynder eller Skifter Systemiske Behandlinger
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.
Studieoversigt
Status
Status
Betingelser
Betingelser
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Trial Transparency email recommended (Toll free for US & Canada)
- Telefonnummer: option 6 800-633-1610
- E-mail: Contact-US@sanofi.com
Studiesteder
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Saskatchewan
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Regina, Saskatchewan, Canada, S4V 1R9
- Rekruttering
- Origins Dermatology Centre-Site Number : 1240003
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Ledende efterforsker:
- Rachel Asiniwasis
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Kontakt:
- Rachel Asiniwasis
- Telefonnummer: 3065527546
- E-mail: rasiniwasis@gmail.com
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Abu Dhabi, Forenede Arabiske Emirater, 66566
- Rekruttering
- Mediclinic Hospital, AUH-Site Number: 7840004
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Kontakt:
- Hussein Abdel Dayem
- Telefonnummer: +979126139438
- E-mail: habdeldayem@mediclinic.ae
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Ledende efterforsker:
- Hussein Abdel Dayem
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Abu Dhabi, Forenede Arabiske Emirater, 6222
- Rekruttering
- NMC Specialty Hospital-Site Number : 7840002
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Kontakt:
- Ahmed Ameen
- Telefonnummer: +97126179161
- E-mail: ahmed.ameen@nmc.ae
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Ledende efterforsker:
- Ahmed Ameen
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Al Karama, Forenede Arabiske Emirater, 50730
- Rekruttering
- Dr Joseph Polyclinic Amber Clinic-Site Number: 7840005
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Kontakt:
- Srikumar Goturu
- Telefonnummer: +96643378828
- E-mail: docsrikumar@gmail.com
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Ledende efterforsker:
- Srikumar Goturu
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Dubai, Forenede Arabiske Emirater, 00000
- Rekruttering
- Dermatology and Aesthetic Center Rashid Hospital-Site Number : 7840003
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Kontakt:
- Amani Abdulla Rahma Alfalasi
- E-mail: aaalfalasi@dubaihealth.ae
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Ledende efterforsker:
- Amani Abdulla Rahma Alfalasi
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Alabama
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Birmingham, Alabama, Forenede Stater, 35244
- Rekruttering
- Cahaba Dermatology & Skin Health Center- Site Number : 8400006
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Ledende efterforsker:
- Vlada Groysman
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Kontakt:
- Vlada Groysman
- Telefonnummer: 205-778-1564
- E-mail: vlada.groysman@cahabaderm.com
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Montgomery, Alabama, Forenede Stater, 36117
- Rekruttering
- River Region Dermatology and Laser- Site Number : 8400041
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Ledende efterforsker:
- Porcia Love
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Kontakt:
- Porcia Love
- Telefonnummer: 334-676-3366
- E-mail: drc.drlove@gmail.com
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Arizona
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Gilbert, Arizona, Forenede Stater, 85234
- Rekruttering
- San Tan Allergy & Asthma- Site Number : 8400031
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Kontakt:
- Sam Reed Shimamoto
- Telefonnummer: 4806266600
- E-mail: rshimamoto@santanallergy.com
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Ledende efterforsker:
- Sam Reed Shimamoto
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Phoenix, Arizona, Forenede Stater, 85008
- Rekruttering
- Saguaro Dermatology- Site Number : 8400028
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Ledende efterforsker:
- Dathan Hamann
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Kontakt:
- Dathan Hamann
- Telefonnummer: 480-562-3610
- E-mail: dhamann@saguaroderm.com
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California
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Bakersfield, California, Forenede Stater, 93301
- Rekruttering
- Kern Research, Inc.- Site Number : 8400047
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Ledende efterforsker:
- Tonny Tanus
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Kontakt:
- Tonny Tanus
- Telefonnummer: 661-864-7710
- E-mail: drttanus@kernresearch.com
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Fremont, California, Forenede Stater, 94538
- Rekruttering
- Center for Dermatology Clinical Research- Site Number : 8400014
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Ledende efterforsker:
- Sunil Dhawan
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Kontakt:
- Sunil Dhawan
- Telefonnummer: 510-797-4111
- E-mail: sdhaw@yahoo.com
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Los Angeles, California, Forenede Stater, 90045
- Rekruttering
- Dermatology Research Associates - Los Angeles- Site Number : 8400020
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Ledende efterforsker:
- Howard Sofen
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Kontakt:
- Howard Sofen
- Telefonnummer: 310-337-7171
- E-mail: hsofen@ucla.edu
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Northridge, California, Forenede Stater, 91325
- Rekruttering
- Northridge Clinical Trials, LLC- Site Number : 8400009
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Ledende efterforsker:
- Navid Ezra
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Kontakt:
- Navid Ezra
- Telefonnummer: 714-375-5970
- E-mail: nezra@northridgetrials.com
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Oakland, California, Forenede Stater, 94596
- Rekruttering
- Sunwise Clinical Research, LLC.- Site Number : 8400010
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Kontakt:
- Michael Abdel Malek
- Telefonnummer: 9252985147
- E-mail: mike@sunclin.com
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Ledende efterforsker:
- Michael Abdel Malek
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Pomona, California, Forenede Stater, 91767
- Rekruttering
- Empire Clinical Research, LLC- Site Number : 8400007
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Kontakt:
- Usha Mantha
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Ledende efterforsker:
- Usha Mantha
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San Diego, California, Forenede Stater, 92123
- Rekruttering
- University Clinical Trials- Site Number : 8400019
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Ledende efterforsker:
- Walter Nahm
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Kontakt:
- Walter Nahm
- Telefonnummer: 85827884701005
- E-mail: walter@univct.com
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Colorado
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Wheat Ridge, Colorado, Forenede Stater, 80033
- Rekruttering
- Western States Clinical Research, Inc.- Site Number : 8400051
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Ledende efterforsker:
- Jeffrey Rumbyrt
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Kontakt:
- Jeffrey Rumbyrt
- Telefonnummer: 303-940-9773
- E-mail: jrumbyrt@denverallergy.com
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Florida
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Doral, Florida, Forenede Stater, 33172
- Rekruttering
- St. Jude Clinical Research- Site Number : 8400049
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Kontakt:
- Gustavo Torres
- Telefonnummer: 305-507-2273
- E-mail: gtorres@stjudeclinicalresearch.com
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Ledende efterforsker:
- Gustavo Torres
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North Miami Beach, Florida, Forenede Stater, 33162-4708
- Rekruttering
- Ziaderm Research, LLC- Site Number : 8400021
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Ledende efterforsker:
- Tory Sullivan
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Kontakt:
- Tory Sullivan
- Telefonnummer: 305-652-8600
- E-mail: drtory@sullivandermatology.com
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Georgia
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Macon, Georgia, Forenede Stater, 31217
- Rekruttering
- Skin Care Physicians of Georgia - Macon- Site Number : 8400034
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Ledende efterforsker:
- David Cohen
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Kontakt:
- David Cohen
- Telefonnummer: 478-742-2180
- E-mail: bedadoc@aol.com
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Illinois
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Normal, Illinois, Forenede Stater, 61761
- Rekruttering
- Sneeze, Wheeze, & Itch Associates, LLC- Site Number : 8400029
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Ledende efterforsker:
- Dareen Siri
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Kontakt:
- Dareen Siri
- Telefonnummer: 309-452-0995
- E-mail: drsiri@asthma2.com
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North Chicago, Illinois, Forenede Stater, 60064
- Rekruttering
- Rosalind Franklin University of Medicine and Science- Site Number: 8400056
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Ledende efterforsker:
- Raj Chovatiya
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Kontakt:
- Raj Chovatiya
- Telefonnummer: 847-578-3000
- E-mail: rchovatiya@docsdermgroup.com
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48103
- Rekruttering
- David Fivenson, MD, Dermatology, PLLC- Site Number : 8400017
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Ledende efterforsker:
- David Fivenson
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Kontakt:
- David Fivenson
- Telefonnummer: 734-222-9630
- E-mail: dfivenson@fivensondermatology.com
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Auburn Hills, Michigan, Forenede Stater, 48326
- Rekruttering
- Oakland Hills Dermatology- Site Number : 8400042
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Ledende efterforsker:
- Christofer Buatti
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Kontakt:
- Christofer Buatti
- Telefonnummer: 248-858-2255
- E-mail: buattichris@yahoo.com
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Bay City, Michigan, Forenede Stater, 48706
- Rekruttering
- Great Lakes Research Group - Bay City- Site Number : 8400052
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Ledende efterforsker:
- Brent Boyce
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Kontakt:
- Brent Boyce
- Telefonnummer: 989-895-9100
- E-mail: bboyce@glrg.net
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Caledonia, Michigan, Forenede Stater, 49316
- Rekruttering
- The Derm Institute of West Michigan- Site Number : 8400025
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Ledende efterforsker:
- Kristi Hawley
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Kontakt:
- Kristi Hawley
- Telefonnummer: 616-512-4445
- E-mail: pi@derminstituteofwmi.com
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Kontakt:
- Kristi Hawley
- Telefonnummer: 6165124445
- E-mail: pi@derminstituteofwmi.com
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Detroit, Michigan, Forenede Stater, 48201
- Rekruttering
- Wayne State University - Detroit Medical Center- Site Number : 8400035
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Ledende efterforsker:
- Steven Daveluy
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Kontakt:
- Steven Daveluy
- Telefonnummer: 313-429-7854
- E-mail: sdaveluy@med.wayne.edu
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Waterford, Michigan, Forenede Stater, 48328
- Rekruttering
- Michigan Dermatology Institute - Waterford- Site Number : 8400013
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Kontakt:
- Cory Rubin
- Telefonnummer: 248-681-9541
- E-mail: cory.rubin@michigandermatologyinstitute.com
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Ledende efterforsker:
- Cory Rubin
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Missouri
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Bolivar, Missouri, Forenede Stater, 65613
- Rekruttering
- Red River Research Partners, Llc- Site Number : 8400054
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Kontakt:
- Murphy Mastin
- Telefonnummer: 417-493-8553
- E-mail: mmastin@redriverresearchpartners.com
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Ledende efterforsker:
- Murphy Mastin
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Kirksville, Missouri, Forenede Stater, 63501
- Rekruttering
- Cleaver Dermatology- Site Number : 8400033
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Kontakt:
- David Cleaver
- Telefonnummer: 660-627-7546
- E-mail: drdavid@cleaverderm.com
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Ledende efterforsker:
- David Cleaver
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68510
- Rekruttering
- Allergy Asthma & Immunology- Site Number : 8400044
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Ledende efterforsker:
- Robert Szalewski
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Kontakt:
- Robert Szalewski
- Telefonnummer: 402-486-3430
- E-mail: rszalewski@allergyasthmaimm.com
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89144
- Rekruttering
- Las Vegas Dermatology- Site Number : 8400002
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Ledende efterforsker:
- Harry Greenberg
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Kontakt:
- Harry Greenberg
- Telefonnummer: 702-456-3120
- E-mail: hlgreenberg@yahoo.com
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New Hampshire
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Portsmouth, New Hampshire, Forenede Stater, 03801
- Rekruttering
- Optima Research Portsmouth- Site Number : 8400032
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Ledende efterforsker:
- Abel Jarell
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Kontakt:
- Abel Jarell
- Telefonnummer: 603-441-1075
- E-mail: ajarell@stracskin.com
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87106
- Rekruttering
- University Of New Mexico School Of Medicine- Site Number : 8400022
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North Carolina
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Huntersville, North Carolina, Forenede Stater, 28078
- Rekruttering
- Piedmont Plastic Surgery and Dermatology- Site Number : 8400038
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Kontakt:
- Nicole Seminara Zambrzycka
- Telefonnummer: 800-785-3150
- E-mail: nseminaramd@onsiteclinical.com
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Ledende efterforsker:
- Nicole Seminara Zambrzycka
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Winston-Salem, North Carolina, Forenede Stater, 27104
- Rekruttering
- Wake Forest University Health Sciences- Site Number : 8400003
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Ledende efterforsker:
- Steven Feldman
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Kontakt:
- Steven Feldman
- Telefonnummer: 336-716-7740
- E-mail: steven.feldman@advocatehealth.org
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58103
- Rekruttering
- Red River Research Partners - Fargo- Site Number : 8400037
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Ledende efterforsker:
- Michael Blankinship
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Kontakt:
- Michael Blankinship
- Telefonnummer: 701-941-9601
- E-mail: michael@redriverresearchpartners.com
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Ohio
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Marion, Ohio, Forenede Stater, 43302
- Rekruttering
- Dermatology Associates of Mid-Ohio- Site Number : 8400026
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Kontakt:
- George Scott Drew
- Telefonnummer: 740-244-8559
- E-mail: spfxv@aol.com
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Ledende efterforsker:
- George Scott Drew
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Mason, Ohio, Forenede Stater, 45040
- Rekruttering
- Dermatologists of Southwest Ohio - Mason- Site Number : 8400050
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Ledende efterforsker:
- Rocco Serrao
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Kontakt:
- Rocco Serrao
- Telefonnummer: 513-701-5526
- E-mail: rserrao@dermswohio.com
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Rekruttering
- UPMC - Department of Dermatology- Site Number : 8400024
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Ledende efterforsker:
- Joe Tung
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Kontakt:
- Joe Tung
- Telefonnummer: 412-647-2013
- E-mail: tungjk@upmc.edu
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Rhode Island
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Warwick, Rhode Island, Forenede Stater, 02886
- Rekruttering
- Care Access Research - Warwick 2- Site Number : 8400045
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Kontakt:
- John Zwetchkenbaum
- Telefonnummer: 401-340-3695
- E-mail: john.zwetchkenbaum.pi@careaccess.com
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Ledende efterforsker:
- John Zwetchkenbaum
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South Carolina
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Spartanburg, South Carolina, Forenede Stater, 29307
- Rekruttering
- Advanced Dermatology and Cosmetic Surgery - Spartanburg- Site Number : 8400004
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Kontakt:
- Amylynne Frankel
- Telefonnummer: 864-574-0017
- E-mail: drafrankel@adcsclinics.com
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Ledende efterforsker:
- Amylynne Frankel
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Texas
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Dallas, Texas, Forenede Stater, 75235
- Rekruttering
- Reveal Research Institute - Dallas- Site Number : 8400012
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Ledende efterforsker:
- Aaron Farberg
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Kontakt:
- Aaron Farberg
- Telefonnummer: 97279792971
- E-mail: afarberg@revealinstitute.com
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Fort Worth, Texas, Forenede Stater, 76244
- Afsluttet
- Innovate Research - Fort Worth- Site Number : 8400016
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Pflugerville, Texas, Forenede Stater, 78660
- Rekruttering
- Austin Institute for Clinical Research, Inc- Site Number : 8400030
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Ledende efterforsker:
- Edward Lain
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Kontakt:
- Edward Lain
- Telefonnummer: 512-279-2545
- E-mail: drlain@atxresearch.com
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Sugar Land, Texas, Forenede Stater, 77479
- Rekruttering
- Complete Dermatology - Sugar Land- Site Number : 8400001
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Ledende efterforsker:
- Bartley Gill
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Kontakt:
- Bartley Gill
- Telefonnummer: 281-240-4313
- E-mail: bj.gill1@gmail.com
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Utah
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Bountiful, Utah, Forenede Stater, 84010
- Rekruttering
- Cope Family Medicine - Ogden Clinic- Site Number : 8400053
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Springville, Utah, Forenede Stater, 84663
- Rekruttering
- Springville Dermatology - Springville- Site Number : 8400055
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Kontakt:
- Michael Peterson
- Telefonnummer: 385-327-5115
- E-mail: michaelpeterson@cctresearch.com
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Ledende efterforsker:
- Michael Peterson
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Virginia
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Falls Church, Virginia, Forenede Stater, 22042
- Rekruttering
- Fuchs Dermatology- Site Number : 8400027
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Kontakt:
- Aaron Fuchs
- Telefonnummer: 703-578-1770
- E-mail: aaron.fuchs@gmail.com
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Ledende efterforsker:
- Aaron Fuchs
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Washington
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Mill Creek, Washington, Forenede Stater, 98012
- Rekruttering
- Frontier Dermatology Partners CRO LLC- Site Number : 8400011
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Kontakt:
- Eingun James Song
- Telefonnummer: 4252754404
- E-mail: eingun.song@frontierdermpartners.com
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Ledende efterforsker:
- Eingun James Song
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Seattle, Washington, Forenede Stater, 98105
- Rekruttering
- University of Washington - Roosevelt Location- Site Number : 8400005
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Kontakt:
- Vivian Shi
- Telefonnummer: 501-526-6994
- E-mail: dermtrials@uw.edu
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Ledende efterforsker:
- Vivian Shi
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Doubs
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Besançon, Doubs, Frankrig, 25030
- Rekruttering
- CHU Besançon - Hôpital Jean Minjoz-Site Number: 2500010
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Ledende efterforsker:
- Francois Aubin
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Kontakt:
- Francois Aubin
- Telefonnummer: +33381218483
- E-mail: faubin@chu-besancon.fr
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Drome
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Valence, Drome, Frankrig, 26000
- Rekruttering
- Centre Hospitalier de Valence-Site Number: 2500005
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Kontakt:
- Anne Grange
- Telefonnummer: +33475757737
- E-mail: aprunier@ch-valence.fr
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Ledende efterforsker:
- Anne Grange
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Haut Rhin
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Mulhouse, Haut Rhin, Frankrig, 68100
- Rekruttering
- GHRMSA - Hospital Emile Muller-Site Number : 2500006
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Kontakt:
- Catherine Michel
- Telefonnummer: +33389646185
- E-mail: michelc@ghrmsa.fr
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Ledende efterforsker:
- Catherine Michel
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Reunion
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Saint-Pierre, Reunion, Frankrig, 97448
- Rekruttering
- CHU de La Reunion-Site Number: 2500007
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Ledende efterforsker:
- Antoine Bertolotti
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Kontakt:
- Antoine Bertolotti
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Rhone
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Romans-sur-Isère, Rhone, Frankrig, 26102
- Rekruttering
- Hopitaux Drome Nord-Site Number : 2500002
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Ledende efterforsker:
- Francois Skowron
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Kontakt:
- Francois Skowron
- Telefonnummer: +33475757575
- E-mail: f.skowron@ch-hdn.fr
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Saone Et Loire
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Chalon-sur-Saône, Saone Et Loire, Frankrig, 71100
- Rekruttering
- Centre Hospitalier William Morey-Site Number: 2500008
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Kontakt:
- Marie Dhers
- Telefonnummer: +33385910402
- E-mail: marie.dhers@ch-chalon71.fr
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Ledende efterforsker:
- Marie Dhers
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Sarthe
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Le Mans, Sarthe, Frankrig, 72037
- Rekruttering
- Centre Hospitalier du Mans-Site Number: 2500004
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Kontakt:
- Nathalie Beneton Benhard
- Telefonnummer: +33243434343
- E-mail: nbeneton@ch-lemans.fr
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Ledende efterforsker:
- Nathalie Beneton Benhard
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Ancona, Italien, 60126
- Rekruttering
- Azienda Ospedaliero Universitaria delle Marche-Site Number: 3800009
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Ledende efterforsker:
- Oriana Simonetti
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Kontakt:
- Oriana Simonetti
- Telefonnummer: +390715963494
- E-mail: oriana.simonetti@ospedaliriuniti.marche.it
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Novara, Italien, 28100
- Rekruttering
- Ospedale Maggiore di Novara-Site Number: 3800005
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Kontakt:
- Paola Savoia
- Telefonnummer: +393213733387
- E-mail: paola.savoia@med.uniupo.it
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Ledende efterforsker:
- Paola Savoia
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Reggio Emilia, Italien, 42100
- Rekruttering
- Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia-Site Number : 3800006
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Kontakt:
- Vito Di Lernia
- Telefonnummer: +39522296654
- E-mail: vito.dilernia@ausl.re.it
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Ledende efterforsker:
- Vito Di Lernia
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Roma, Italien, 00144
- Rekruttering
- Istituto San Gallicano IRCCS - Istituti Fisioterapici Ospitalieri-Site Number: 3800002
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Kontakt:
- Maria Concetta Fargnoli
- Telefonnummer: +39862368519
- E-mail: mariaconcetta.fargnoli@ifo.it
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Ledende efterforsker:
- Maria Concetta Fargnoli
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Kagawa-ken
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Marugame-shi, Kagawa-ken, Japan, 763-0074
- Rekruttering
- Takeoka Dermatology Clinic- Site Number : 3920005
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Kontakt:
- Shintaro Takeoka
- Telefonnummer: +81877251880
- E-mail: takexile1130@gmail.com
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Ledende efterforsker:
- Shintaro Takeoka
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Osaka
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Habikino-shi, Osaka, Japan, 583-8588
- Rekruttering
- Osaka Habikino Medical Center-Site Number : 3920001
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Ledende efterforsker:
- Yoko Kataoka
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Kontakt:
- Yoko Kataoka
- Telefonnummer: +81729572121
- E-mail: chiken_jimu@ra.opho.jp
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Shizuoka
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Hamamatsu, Shizuoka, Japan, 430-0929
- Rekruttering
- JA-Shizuoka Enshu Hospital-Site Number: 3920003
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Kontakt:
- Chika Shibuya
- Telefonnummer: +81534531111
- E-mail: chikashibu2@gmail.com
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Ledende efterforsker:
- Chika Shibuya
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Chongqing, Kina, 400016
- Rekruttering
- The First Affiliated Hospital of Chongqing Medical University-Site Number : 1560011
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Kontakt:
- Tao Cai
- Telefonnummer: +8615902305525
- E-mail: caidaodao@hotmail.com
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Ledende efterforsker:
- Tao Cai
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Shanghai, Kina, 200040
- Rekruttering
- Huashan Hospital, Fudan University-Site Number: 1560012
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Ledende efterforsker:
- Wei Li
-
Kontakt:
- Wei Li
- Telefonnummer: +8618629352992
- E-mail: liweiderma@fudan.edu.cn
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100191
- Rekruttering
- Peking University Third Hospital-Site Number: 1560008
-
Ledende efterforsker:
- Wenhui Wang
-
Kontakt:
- Wenhui Wang
- Telefonnummer: +8618618269437
- E-mail: wwh0608@126.com
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Guangdong
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Shenzhen, Guangdong, Kina, 518033
- Rekruttering
- The Eighth Affiliated Hospital, Sun Yat-sen University-Site Number: 1560006
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Kontakt:
- Peimei Zhou
- Telefonnummer: +8613880699378
- E-mail: 46551704@qq.com
-
Ledende efterforsker:
- Peimei Zhou
-
-
Hu'nan
-
Changsha, Hu'nan, Kina, 410008
- Rekruttering
- Xiangya Hospital of Central South University-Site Number : 1560001
-
Ledende efterforsker:
- Juan Su
-
Kontakt:
- Juan Su
- Telefonnummer: +8615116408921
- E-mail: 540020068@qq.com
-
Changsha, Hu'nan, Kina, 410011
- Rekruttering
- The Second Xiangya Hospital of Central South University-Site Number: 1560014
-
Ledende efterforsker:
- Yunsheng Liang
-
Kontakt:
- Yunsheng Liang
- Telefonnummer: +8615973189908
- E-mail: yunshengliang@aliyun.com
-
-
Shanxi
-
Xi’an, Shanxi, Kina, 710004
- Rekruttering
- The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)-Site Number: 1560002
-
Ledende efterforsker:
- Songmei Geng
-
Kontakt:
- Songmei Geng
- Telefonnummer: +8613060423612
- E-mail: gengsongmei73@163.com
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610041
- Rekruttering
- West China Hospital, Sichuan University- Site Number: 1560003
-
Ledende efterforsker:
- Jingyi Li
-
Kontakt:
- Jingyi Li
- Telefonnummer: +8618980605704
- E-mail: ljy7733@163.com
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310006
- Rekruttering
- Hangzhou First People's Hospital-Site Number: 1560004
-
Ledende efterforsker:
- Liming Wu
-
Kontakt:
- Liming Wu
- Telefonnummer: +8613750837205
- E-mail: 18957118053@163.com
-
Hangzhou, Zhejiang, Kina, 310009
- Rekruttering
- The Second Affiliated Hospital of Zhejiang University School of Medicine-Site Number: 1560007
-
Ledende efterforsker:
- Xiaoyong Man
-
Kontakt:
- Xiaoyong Man
- Telefonnummer: +8613600516219
- E-mail: manxy@zju.edu.cn
-
Ningbo, Zhejiang, Kina, 315010
- Rekruttering
- The First Affiliated Hospital of Ningbo University-Site Number : 1560009
-
Kontakt:
- Bingjiang Lin
- Telefonnummer: +8617757461212
- E-mail: linbingj@163.com
-
Ledende efterforsker:
- Bingjiang Lin
-
-
-
-
-
Jeddah, Saudi Arabien, 21452
- Rekruttering
- Erfan and Bagedo Hospital-Site Number : 6820002
-
Kontakt:
- Ahmed Ismail Ebraheem Abdellateef
- Telefonnummer: +96602613888
- E-mail: drahmedismail2006@gmail.com
-
Ledende efterforsker:
- Ahmed Ismail Ebraheem Abdellateef
-
Jeddah, Saudi Arabien, 23421
- Rekruttering
- Medical Fakeeh-Site Number : 6820003
-
Kontakt:
- Ayman Elgendi
- Telefonnummer: +966507364687
- E-mail: aymanelgendy91@yahoo.com
-
Ledende efterforsker:
- Ayman Elgendi
-
Riyadh, Saudi Arabien, 12231
- Rekruttering
- King Fahad Medical City-Site Number : 6820001
-
Kontakt:
- Mohammed Alajlan
- Telefonnummer: +96612889999
- E-mail: malajlan@kfmc.med.sa
-
Ledende efterforsker:
- Mohammed Alajlan
-
-
-
-
-
Alicante, Spanien, 03010
- Rekruttering
- Hospital General Universitario Dr. Balmis-Site Number: 7240005
-
Ledende efterforsker:
- Juan Francisco Silvestre Salvador
-
Kontakt:
- Juan Francisco Silvestre Salvador
- Telefonnummer: +34965913723
- E-mail: silvestre.jfr@gmail.com
-
-
Catalunya [Cataluña]
-
Barcelona, Catalunya [Cataluña], Spanien, 08041
- Rekruttering
- Investigational Site Number : 7240006
-
-
Tenerife
-
Santa Cruz de Tenerife, Tenerife, Spanien, 38320
- Rekruttering
- Hospital Universitario de Canarias-Site Number: 7240008
-
Ledende efterforsker:
- Ruperto Gonzalez Perez
-
Kontakt:
- Ruperto Gonzalez Perez
- Telefonnummer: +34922677231
- E-mail: glezruperto@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Patients with any atopic dermatitis severity will be invited to enroll in the registry after the decision has been made to initiate a new systemic medication for the first time or switch systemic therapies. Inclusion in the registry will not influence a patient's treatment course.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Antal grupper/kohorter
Kohorter og interventioner
Gruppe / kohorteGruppe / kohorte |
|---|
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Utilizing Atopic Dermatitis (AD) Treatment
Tidsramme: Baseline to up to 60 months
|
The number (and percentage) of participants taking AD treatments and treatments per patient will be described. |
Baseline to up to 60 months
|
|
Duration of Treatment
Tidsramme: Baseline to up to 60 months
|
The duration of AD treatments will be summarized descriptively. |
Baseline to up to 60 months
|
|
AD Treatment Sequences
Tidsramme: Baseline to up to 60 months
|
The ordering of AD treatments will be summarized descriptively. |
Baseline to up to 60 months
|
|
Number of Participants Initiating AD Treatments with Reasons
Tidsramme: Baseline to up to 60 months
|
The number (and percentage) of patients initiating AD treatment and reasons for initiation will be summarized descriptively. |
Baseline to up to 60 months
|
|
Number of Participants Interrupting AD Treatment
Tidsramme: Baseline to up to 60 months
|
The number (and percentage) of patients interrupting AD treatment and reasons for treatment interruption will be summarized descriptively. |
Baseline to up to 60 months
|
|
Number of Participants Discontinuing AD Treatment
Tidsramme: Baseline to up to 60 months
|
The number (and percentage) of patients discontinuing AD treatment and reasons for treatment discontinuation will be summarized descriptively. |
Baseline to up to 60 months
|
|
Number of Participants Switching AD Treatments
Tidsramme: Baseline to up to 60 months
|
The number (and percentage) of patients switching AD treatment and reasons for treatment switch will be summarized descriptively. |
Baseline to up to 60 months
|
|
Number of Participants Augmenting AD treatment
Tidsramme: Baseline to up to 60 months
|
The number (and percentage) of patients augmenting AD treatment will be summarized descriptively. |
Baseline to up to 60 months
|
|
Number of Participants Modifying AD Treatment Dose
Tidsramme: 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. |
Baseline to up to 60 months
|
|
Change from Baseline in Extent and Severity of AD Measured with Eczema Area and Severity Index (EASI)
Tidsramme: 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. |
Baseline to up to 60 months
|
|
Change from Baseline in Extent and Severity of AD Measured with Body Surface Area (BSA)
Tidsramme: 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. |
Baseline to up to 60 months
|
|
Change from Baseline in Extent and Severity of AD Measured with Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD)
Tidsramme: 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. |
Baseline to up to 60 months
|
|
Change from Baseline in Extent and Severity of AD Measured with Revised Investigator's Global Assessment for Atopic Dermatitis (rIGA-AD)
Tidsramme: 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. |
Baseline to up to 60 months
|
|
Change in Atopic Dermatitis Control Test (ADCT) from Baseline
Tidsramme: 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. |
Baseline to up to 60 months
|
|
Change in Patient Global Impression of Severity (PGIS) from Baseline
Tidsramme: 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. |
Baseline to up to 60 months
|
|
Change in Itch severity as Measured with the Peak Pruritus Numeric Rating Scale (PP-NRS) from Baseline
Tidsramme: 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. |
Baseline to up to 60 months
|
|
Change in Skin Pain as Measured with Skin Pain Numeric Rating Scale (SP-NRS) from Baseline
Tidsramme: 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. |
Baseline to up to 60 months
|
|
Change in Sleep Disturbance as Measured with Sleep Disturbance Numeric Rating Scale (SD-NRS) from Baseline
Tidsramme: 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. |
Baseline to up to 60 months
|
|
Remission of AD
Tidsramme: Baseline to up to 60 months
|
Total remission of all signs and symptoms of AD will be assessed. |
Baseline to up to 60 months
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sociodemographic characteristics of Participants
Tidsramme: Baseline
|
Demographics characteristics including age, sex, body weight, height, geographic region, education level, employment status, smoking and alcohol status will be collected. |
Baseline
|
|
Ethnic Origin in Combination with Fitzpatrick Scale
Tidsramme: Baseline
|
The Fitzpatrick Skin Type Scale was developed based on an individual's reaction to sun exposure and will be completed by the Investigator. Skin types range from I - VI, with scores of I indicating the palest skin tone with no inherent melanin pigmentation, and VI indicating the darkest skin tone with significant amount of melanin. |
Baseline
|
|
Disease characteristics of Participants
Tidsramme: Baseline
|
History of AD (including date of diagnosis, age of onset, specialty of provider who diagnosed condition), AD morphology, including but not limited to, patches, plaques, prurigo nodules, lichenoid papules, perifollicular papules, nummular lesions, and psoriasiform lesions and family history of AD and comorbidities will be collected. |
Baseline
|
|
Change from Baseline in Dermatology-specific Quality of Life Measure with Dermatology Life Quality Index (DLQI)
Tidsramme: Baseline to up to 60 months
|
DLQI is calculated by summing the score of each question resulting in a maximum score of 30 and a minimum score of 0 (higher scores indicate quality of life is more impaired). |
Baseline to up to 60 months
|
|
Change from Baseline in Dermatology-specific Quality of Life Measure with Children's Dermatology Life Quality Index (CDLQI)
Tidsramme: Baseline to up to 60 months
|
The CDLQI is calculated by summing the score of each question resulting in a maximum score of 30 and a minimum score of 0 (higher scores indicate quality of life is more impaired). |
Baseline to up to 60 months
|
|
Change from Baseline in Burden of Assessment Using Patient Health Questionnaire-9 (PHQ-9)
Tidsramme: Baseline to up to 60 months
|
PHQ-9 is a 9-item, validated, patient-reported questionnaire to assess depression which scores each of the 9 Diagnostic and Statistical Manual of Mental Disorders-IV criteria as "0" (not at all) to "3" (nearly every day). Possible scores range from 0 to 27 and are classified as 1-4: "minimal depression"; 5-9: "mild depression"; 10-14: "moderate depression"; 15-19: "moderately severe depression"; and 20-27: "severe depression". |
Baseline to up to 60 months
|
|
Change from Baseline in AD Specific Work and Classroom Productivity and Impairment Assessed Using WPAI+CIQ
Tidsramme: Baseline to up to 60 months
|
Work Productivity and Activity Impairment plus Classroom Impairment Questions (WPAI+CIQ) is a 10-item, patient-reported, validated questionnaire adapted for AD to measure impairments in work, classroom, and regular daily activities over a 7-day period. |
Baseline to up to 60 months
|
|
Change from Baseline in Treatment Satisfaction Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Tidsramme: Baseline to up to 60 months
|
The 14-item TSQM-9 is a generic measure of treatment satisfaction, assessing side effects, effectiveness, convenience and global satisfaction, over the last 2 to 3 weeks, or since the patient has last used it. A lower score indicates lower satisfaction with treatment. |
Baseline to up to 60 months
|
|
Visits with Specialty of Attending Healthcare Provider and Reason for Visit
Tidsramme: Baseline to up to 60 months
|
Health care resource utilization including visits with specialty of attending health care provider and reason for visit (example, disease flare-up, regular visit, prescription change, adverse event [AE]) will be assessed. |
Baseline to up to 60 months
|
|
Hospitalizations for AD
Tidsramme: Baseline to up to 60 months
|
Hospitalization for AD will be assessed. |
Baseline to up to 60 months
|
|
Prevalence of Comorbid Atopic Conditions
Tidsramme: Baseline to up to 60 months
|
Prevalence of comorbid atopic conditions (including but not limited to, asthma, allergic conjunctivitis, allergic rhinitis, eosinophilic esophagitis, nasal polyposis, food allergy, prurigo nodularis, chronic spontaneous urticaria, and rhinoconjunctivitis) and non-atopic conditions (including but not limited to, insomnia, anxiety, attention deficit disorder, depression, major adverse cardiovascular event, cardiovascular disease, skin infection, pulmonary disease, osteoporosis, fractures, contact allergy, and inflammatory conditions) will be assessed. |
Baseline to up to 60 months
|
|
Incidence of Comorbid Atopic Conditions
Tidsramme: Baseline to up to 60 months
|
Incidence of comorbid atopic conditions (including but not limited to, asthma, allergic conjunctivitis, allergic rhinitis, eosinophilic esophagitis, nasal polyposis, food allergy, prurigo nodularis, chronic spontaneous urticaria, and rhinoconjunctivitis) and non-atopic conditions (including but not limited to, insomnia, anxiety, attention deficit disorder, depression, major adverse cardiovascular event, cardiovascular disease, skin infection, pulmonary disease, osteoporosis, fractures, contact allergy, and inflammatory conditions) will be assessed. |
Baseline to up to 60 months
|
|
Change from Baseline in Asthma Control Assessed with Asthma Control Questionnaire-5 (ACQ-5)
Tidsramme: Baseline to up to 60 months
|
ACQ-5 is a 5-item questionnaire used to assess asthma control [33]. Each question is rated on a 7-point scale (0=no impairment; 6=maximum impairment). The ACQ-5 score is calculated using the mean of the 5 items and ranges between 0 (well controlled asthma) to 6 (extremely poorly controlled asthma). The ACQ-5 will only be completed by patients with comorbid asthma. |
Baseline to up to 60 months
|
|
Occurrence of Concomitant Medication use for AD and Selected Comorbidities
Tidsramme: Baseline to up to 60 months
|
The occurrence of concomitant medication use for AD and selected comorbidities at baseline and changes (including reason for change) will be summarized. |
Baseline to up to 60 months
|
|
Number of Adverse Events (SAEs)
Tidsramme: Baseline to up to 60 months
|
Number of patients experiencing AEs. |
Baseline to up to 60 months
|
|
Number of Serious Adverse Events (SAEs)
Tidsramme: Baseline to up to 60 months
|
Number of patients experiencing SAEs. |
Baseline to up to 60 months
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- OBS18388
- U1111-1311-1824 (Registry Identifier: ICTRP)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .