NCT ID: NCT03568318
Last Updated: March 31, 2022
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
Status: Active, not recruiting
Phase: Phase 3
Gender: All
Age: 12 Years - 75 Years
Condition: Atopic Dermatitis
Study Type: Interventional
Lead Sponsor: AbbVie
Ages Eligible for Study: 12 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria: - Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and < 18 years of age - Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit and subject meets Hanifin and Rajka criteria. - Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) ≥ 4. - Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit. - Documented history of inadequate response to topical corticosteroids or topical calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to Baseline Visit Exclusion Criteria: - Prior exposure to any Janus kinase (JAK) inhibitor - Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study - Requirement of prohibited medications during the study - Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions - Female subject who is pregnant, breastfeeding, or considering pregnancy during the study
Collaborators: Not provided
Investigators: ABBVIE INC.
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Total Skin and Beauty Derm Ctr /ID# 200548 Birmingham, Alabama, United States |
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Clinical Research Center AL /ID# 201865 Birmingham, Alabama, United States |
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ACCEL Research Sites /ID# 213364 Birmingham, Alabama, United States |
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Advanced Dermatology and Skin Care Centre /ID# 213550 Mobile, Alabama, United States |
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Arizona Research Center, Inc. /ID# 200546 Phoenix, Arizona, United States |
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Clear Dermatology & Aesthetics Center /ID# 201257 Scottsdale, Arizona, United States |
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University of Arizona /ID# 201059 Tucson, Arizona, United States |
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Bakersfield Derma & Skin Cance /ID# 200892 Bakersfield, California, United States |
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Mosaic Dermatology /ID# 200553 Beverly Hills, California, United States |
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University of California Irvine /ID# 200902 Irvine, California, United States |
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Therapeutics Clinical Research /ID# 200593 San Diego, California, United States |
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Stanford University /ID# 200597 Stanford, California, United States |
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Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822 Aurora, Colorado, United States |
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Colorado Center for Dermatology, PLLC /ID# 203626 Centennial, Colorado, United States |
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Duplicate_Western States Clinical Research, Inc. /ID# 201702 Wheat Ridge, Colorado, United States |
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Dermatology Physicians of Connecticut /ID# 201004 Shelton, Connecticut, United States |
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Clearlyderm Dermatology /ID# 207709 Boca Raton, Florida, United States |
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Skin Care Research, LLC /ID# 200812 Boca Raton, Florida, United States |
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Clinical Research of West Florida, Inc /ID# 203643 Clearwater, Florida, United States |
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Florida Academic Centers Research and Education /ID# 200544 Coral Gables, Florida, United States |
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Tory P Sullivan, MD PA /ID# 201174 North Miami Beach, Florida, United States |
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Park Avenue Dermatology, PA /ID# 201012 Orange Park, Florida, United States |
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Precision Clinical Research /ID# 208734 Sunrise, Florida, United States |
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Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628 Boise, Idaho, United States |
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Northwestern University Feinberg School of Medicine /ID# 201646 Chicago, Illinois, United States |
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Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556 Skokie, Illinois, United States |
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DuPage Medical Group /ID# 202065 Wheaton, Illinois, United States |
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Deaconess Clinic Downtown /ID# 201001 Evansville, Indiana, United States |
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Indiana University /ID# 200515 Indianapolis, Indiana, United States |
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Epiphany Dermatology of Kansas LLC /ID# 203026 Overland Park, Kansas, United States |
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ORA, Inc. /ID# 202824 Andover, Massachusetts, United States |
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Tufts Medical Center /ID# 200570 Boston, Massachusetts, United States |
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Beth Israel Deaconess Medical Center /ID# 200545 Boston, Massachusetts, United States |
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Clin Res Inst of Michigan, LLC /ID# 208020 Chesterfield, Michigan, United States |
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Michigan Center for Research Company /ID# 200560 Clarkston, Michigan, United States |
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MediSearch Clinical Trials /ID# 201006 Saint Joseph, Missouri, United States |
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Skin Specialists, PC /ID# 200573 Omaha, Nebraska, United States |
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Dartmouth-Hitchcock Medical Center /ID# 200918 Lebanon, New Hampshire, United States |
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Psoriasis Treatment Center of Central New Jersey /ID# 200714 East Windsor, New Jersey, United States |
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Juva Skin and Laser Center /ID# 200997 New York, New York, United States |
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J. Schwartz, MD, PLLC /ID# 202122 Troy, New York, United States |
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Bexley Dermatology Research /ID# 200899 Bexley, Ohio, United States |
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The Ohio State University /ID# 200542 Columbus, Ohio, United States |
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Vital Prospects Clinical Research Institute, PC /ID# 200901 Tulsa, Oklahoma, United States |
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Oregon Dermatology and Research Center /ID# 200601 Portland, Oregon, United States |
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University of Pittsburgh MC /ID# 206057 Pittsburgh, Pennsylvania, United States |
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Rhode Island Hospital /ID# 200566 Providence, Rhode Island, United States |
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AAPRI Clinical Research /ID# 221134 Warwick, Rhode Island, United States |
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Rivergate Dermatology & Skin Care Center /ID# 201698 Goodlettsville, Tennessee, United States |
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Stones River Dermatology /ID# 204962 Murfreesboro, Tennessee, United States |
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Arlington Research Center, Inc /ID# 200559 Arlington, Texas, United States |
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Center for Clinical Studies /ID# 200582 Houston, Texas, United States |
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Progressive Clinical Research /ID# 201582 San Antonio, Texas, United States |
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Center for Clinical Studies - Webster TX /ID# 203186 Webster, Texas, United States |
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Advanced Clinical Research - Woseth Dermatology /ID# 213745 Salt Lake City, Utah, United States |
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Eastern Virginia Med School /ID# 200994 Norfolk, Virginia, United States |
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Dermatology Associates of Seattle /ID# 200717 Seattle, Washington, United States |
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University of Wisconsin - Madison /ID# 204933 Madison, Wisconsin, United States |
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St George Dermatology & Skin Cancer Centre /ID# 204788 Kogarah, New South Wales, Australia |
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Royal North Shore Hospital /ID# 204639 St Leonards, New South Wales, Australia |
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Westmead Hospital /ID# 205682 Westmead, New South Wales, Australia |
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Veracity Clinical Research /ID# 204793 Woolloongabba, Queensland, Australia |
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Fremantle Dermatology /ID# 205306 Fremantle, Western Australia, Australia |
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Ordensklinikum Linz GmbH Elisabethinen /ID# 209567 Linz, Oberoesterreich, Austria |
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Kepler Universitaetsklinikum GmbH /ID# 201075 Linz, Oberoesterreich, Austria |
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Medizinische Universitaet Innsbruck /ID# 210897 Innsbruck, Tirol, Austria |
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Medizinische Universitaet Wien /ID# 201080 Vienna, Wien, Austria |
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UZ Brussel /ID# 203557 Jette, Bruxelles-Capitale, Belgium |
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UCL Saint-Luc /ID# 202028 Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium |
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UZ Gent /ID# 202030 Gent, Oost-Vlaanderen, Belgium |
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IMTR - Grand Hopital de Charleroi /ID# 202029 Loverval, Belgium |
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Kirk Barber Research, CA /ID# 200329 Calgary, Alberta, Canada |
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Dermatology Research Institute Inc. /ID# 200341 Calgary, Alberta, Canada |
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Alberta DermaSurgery Centre /ID# 205674 Edmonton, Alberta, Canada |
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Karma Clinical Trials /ID# 200339 St. John's, Newfoundland and Labrador, Canada |
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Eastern Canada Cutaneous Resea /ID# 200335 Halifax, Nova Scotia, Canada |
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Lynderm Research Inc. /ID# 200338 Markham, Ontario, Canada |
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DermEdge Research Inc. /ID# 200337 Mississauga, Ontario, Canada |
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The Centre for Clinical Trials /ID# 205404 Oakville, Ontario, Canada |
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Angela Montgomery Medicine Professional Corporation /ID# 212653 Ottawa, Ontario, Canada |
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SKIN Centre for Dermatology /ID# 200331 Peterborough, Ontario, Canada |
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The Center For Dermatology /ID# 205409 Richmond Hill, Ontario, Canada |
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Toronto Research Centre /ID# 205411 Toronto, Ontario, Canada |
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Research Toronto /ID# 205410 Toronto, Ontario, Canada |
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XLR8 Medical Research /ID# 205405 Windsor, Ontario, Canada |
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CHU Sainte-Justine /ID# 206013 Montreal, Quebec, Canada |
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Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403 Québec, Quebec, Canada |
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Dre Angelique Gagne-Henley M.D. inc. /ID# 200330 Saint-Jerome, Quebec, Canada |
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Chinese PLA General Hospital /ID# 206786 Beijing, Beijing, China |
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Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728 Guangzhou, Guangdong, China |
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Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669 Wuhan, Hubei, China |
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The First Hospital of China Medical University /ID# 209840 Shenyang, Liaoning, China |
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The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132 Hangzhou, Zhejiang, China |
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The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442 Hangzhou, Zhejiang, China |
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Beijing Friendship Hospital /ID# 207434 Beijing, China |
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Xiangya Hospital Central South University /ID# 207510 Changsha, China |
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Huashan Hospital of Fudan University /ID# 207437 Shanghai, China |
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Fakultni nemocnice Plzen /ID# 202044 Plzen, Czechia |
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Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248 Prague, Czechia |
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Sanatorium profesora Arenbergera /ID# 202082 Praha, Czechia |
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Vseobecna fakultni nemocnice v Praze /ID# 202045 Praha, Czechia |
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Chu de Nice-Hopital L'Archet Ii /Id# 205780 Nice, Alpes-Maritimes, France |
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AP-HM - Hopital de la Timone /ID# 206128 Marseille CEDEX 05, Bouches-du-Rhone, France |
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CHRU Tours - Hopital Gatien de Clocheville /ID# 218209 Tours, Centre-Val De Loire, France |
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Hopital Saint-Andre /ID# 206129 Bordeaux, France |
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Polyclinique Courlancy /ID# 201537 Reims, France |
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Universitaetsklinik Heidelberg /ID# 202097 Heidelberg, Baden-Wuerttemberg, Germany |
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Universitaetsklinikum Frankfurt /ID# 202095 Frankfurt am Main, Hessen, Germany |
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Universitaetsklinikum Muenster /ID# 202094 Muenster, Nordrhein-Westfalen, Germany |
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CMS3 Company for Medical Study /ID# 205195 Selters, Rheinland-Pfalz, Germany |
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Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256 Kiel, Schleswig-Holstein, Germany |
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Universitaetsklinikum Bonn /ID# 202092 Bonn, Germany |
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TFS Trial Form Support GmbH /ID# 202096 Hamburg, Germany |
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Medizinische Hochschule Hannover /ID# 202098 Hannover, Germany |
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Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194 Mainz, Germany |
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Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093 Munich, Germany |
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401 GSNA - 401 Army General Hospital /ID# 211963 Athens, Attiki, Greece |
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Children's Hosp P. A. Kyriakou /ID# 217573 Athens, Attiki, Greece |
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University General Hospital Attikon /ID# 201126 Athens, Attiki, Greece |
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General Hospital Andreas Syggros /ID# 201123 Athens, Attiki, Greece |
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Papageorgiou General Hospital Thessaloniki /ID# 202392 Stavroupoli (Thessalonikis), Thessaloniki, Greece |
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Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124 Thessaloniki, Greece |
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Prince of Wales Hospital /ID# 205152 Hong Kong, Hong Kong |
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Queen Mary Hospital /ID# 205146 Hong Kong, Hong Kong |
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Oroshazi Korhaz /ID# 203525 Oroshaza, Bekes, Hungary |
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Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144 Szeged, Csongrad, Hungary |
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Debreceni Egyetem Klinikai Kozpont /ID# 201765 Debrecen, Hajdu-Bihar, Hungary |
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Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866 Debrecen, Hungary |
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Allergo-Derm Bakos Kft. /ID# 205361 Szolnok, Hungary |
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St James Hospital /ID# 201118 Dublin 8, Dublin, Ireland |
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South Infirmary Victoria University Hospital /ID# 201079 Cork, Ireland |
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University Hospital Waterford /ID# 201253 Waterford, Ireland |
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Soroka University Medical Center /ID# 206652 Be'er Sheva, HaDarom, Israel |
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The Chaim Sheba Medical Center /ID# 201611 Ramat Gan, Tel-Aviv, Israel |
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Tel Aviv Sourasky Medical Center /ID# 201608 Tel Aviv-Yafo, Tel-Aviv, Israel |
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HaEmek Medical Center /ID# 201958 Afula, Israel |
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Rabin Medical Center /ID# 201959 Petakh Tikva, Israel |
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014 Rome, Lazio, Italy |
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Istituto Clinico Humanitas /ID# 200739 Rozzano, Milano, Italy |
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Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690 Ancona, Italy |
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A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742 Catania, Italy |
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Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744 Milan, Italy |
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Azienda Ospedaliera Universitaria Federico II /ID# 200751 Napoli, Italy |
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Chukyo Hospital /ID# 202311 Nagoya-shi, Aichi, Japan |
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Medical Corporation Matsuo Clinic /ID# 202312 Fukuoka-shi, Fukuoka, Japan |
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Hiroshima University Hospital /ID# 201914 Hiroshima-shi, Hiroshima, Japan |
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Hiramoto skin clinic /ID# 204048 Amagasaki-shi, Hyogo, Japan |
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National Hospital Organization Sagamihara National Hospital /ID# 201658 Sagamihara-shi, Kanagawa, Japan |
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Queens Square Medical Center dermatology allergology /ID# 203850 Yokohama-shi, Kanagawa, Japan |
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Kyoto University Hospital /ID# 201654 Kyoto-shi, Kyoto, Japan |
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Tohoku University Hospital /ID# 206322 Sendai-shi, Miyagi, Japan |
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Osaka Habikino Medical Center /ID# 204243 Habikino-shi, Osaka, Japan |
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Jichi Medical University Hospital /ID# 201913 Shimotsuke-shi, Tochigi, Japan |
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Juntendo University Hospital /ID# 202888 Bunkyo-ku, Tokyo, Japan |
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Tokai University Hachioji Hospital /ID# 201711 Hachioji-shi, Tokyo, Japan |
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Maruyama Dermatology Clinic /ID# 202350 Koto-ku, Tokyo, Japan |
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Yamate Dermatological Clinic /ID# 202130 Shinjuku-ku, Tokyo, Japan |
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Erasmus Medisch Centrum /ID# 202196 Rotterdam, Zuid-Holland, Netherlands |
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Academisch Medisch Centrum /ID# 202193 Amsterdam, Netherlands |
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Universitair Medisch Centrum Groningen /ID# 202195 Groningen, Netherlands |
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Universitair Medisch Centrum Utrecht /ID# 202194 Utrecht, Netherlands |
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Clinical Trials NZ /ID# 205336 Hamilton, New Zealand |
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Haukeland University Hospital /ID# 201152 Bergen, Hordaland, Norway |
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Universitetssykehuset N-Norge, Harstad /ID# 201269 Harstad, Troms, Norway |
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Universitetssykehuset N-Norge, Tromso /ID# 201270 Tromso, Troms, Norway |
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Rikshospitalet OUS HF /ID# 201271 Oslo, Norway |
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Dr. Samuel Sanchez PSC /ID# 202002 Caguas, Puerto Rico |
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Clinical Research Puerto Rico /ID# 203644 San Juan, Puerto Rico |
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GCM Medical Group PSC - Hato Rey /ID# 202003 San Juan, Puerto Rico |
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Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372 Banska Bystrica, Slovakia |
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Univerzitna nemocnica Martin /ID# 203851 Martin, Slovakia |
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Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240 Nove Zamky, Slovakia |
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Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373 Presov, Slovakia |
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Hospital Universitario de Puerto Real /ID# 200875 Puerto Real, Cadiz, Spain |
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Hospital General Universitario Alicante /ID# 200873 Alicante, Spain |
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Hospital Santa Creu i Sant Pau /ID# 201325 Barcelona, Spain |
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Hospital Universitario de la Princesa /ID# 201517 Madrid, Spain |
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Hospital Universitario 12 de Octubre /ID# 201135 Madrid, Spain |
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Hospital Universitario La Paz /ID# 205438 Madrid, Spain |
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Skane University Hospital Lund /ID# 201244 Lund, Skane Lan, Sweden |
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Sahlgrenska University Hospital /ID# 201274 Gothenburg, Vastra Gotalands Lan, Sweden |
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Sodersjukhuset /ID# 201242 Stockholm, Sweden |
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Karolinska University Hospital /ID# 201243 Stockholm, Sweden |
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Barts Health NHS Trust /ID# 201044 London, London, City Of, United Kingdom |
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Guy's and St Thomas' NHS Foundation Trust /ID# 201193 London, London, City Of, United Kingdom |
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Guy's and St Thomas' NHS Foundation Trust /ID# 204642 London, London, City Of, United Kingdom |
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Oxford University Hospitals NHS Foundation Trust /ID# 202052 Oxford, Oxfordshire, United Kingdom |
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NHS Tayside /ID# 202081 Dundee, Scotland, United Kingdom |
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NHS Greater Glasgow and Clyde /ID# 201374 Glasgow, Scotland, United Kingdom |
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Leeds Teaching Hospitals NHS Trust /ID# 201106 Leeds, United Kingdom |