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NCT03568318Active, not recruitingPhase 3

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

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

Source: ClinicalTrials.gov · Last updated 23 Dec 2025

Brief summary (registry, in English)

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 (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1533 (actual)
First submitted
14 Jun 2018
Start date
9 Aug 2018
Primary completion date
16 Feb 2021
Lead sponsor
AbbVie
NCT number
NCT03568318
EU CT number
2022-502937-24-00
EudraCT number
2017-005126-37

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1533
  • From 9 Aug 2018 to the primary completion date, 16 Feb 2021
  • 230 sites in 28 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 illness

  • Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions

Other

  • Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Who the study is looking for

  • 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

Age in the registry: 12 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (230)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet Innsbruck
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InnsbruckAustriaActive, not recruiting
Ordensklinikum Linz GmbH
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LinzAustriaActive, not recruiting
Kepler Universitaetsklinikum GmbH
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LinzAustriaActive, not recruiting
Noe LGA Gesundheit Region Mitte GmbH
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St. PoeltenAustriaActive, not recruiting
Medical University of Vienna
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ViennaAustriaActive, not recruiting
Fremantle Dermatology /ID# 205306
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FremantleAustraliaUnknown status
St George Dermatology & Skin Cancer Centre /ID# 204788
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KogarahAustraliaUnknown status
Royal North Shore Hospital /ID# 204639
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St LeonardsAustraliaUnknown status
Westmead Hospital /ID# 205682
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WestmeadAustraliaUnknown status
Veracity Clinical Research /ID# 204793
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WoolloongabbaAustraliaUnknown status
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
UZ Brussel
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JetteBelgiumActive, not recruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumActive, not recruiting
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
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PlevenBulgariaActive, not recruiting
ASMC IPSMC Skin And Venereal Diseases
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SofiyaBulgariaActive, not recruiting
Kirk Barber Research, CA /ID# 200329
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CalgaryCanadaUnknown status
Dermatology Research Institute Inc. /ID# 200341
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CalgaryCanadaUnknown status
Alberta DermaSurgery Centre /ID# 205674
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EdmontonCanadaUnknown status
Eastern Canada Cutaneous Resea /ID# 200335
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HalifaxCanadaUnknown status
Lynderm Research Inc. /ID# 200338
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MarkhamCanadaUnknown status
DermEdge Research Inc. /ID# 200337
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MississaugaCanadaUnknown status
CHU Sainte-Justine /ID# 206013
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MontrealCanadaUnknown status
The Centre for Clinical Trials /ID# 205404
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OakvilleCanadaUnknown status
Angela Montgomery Medicine Professional Corporation /ID# 212653
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OttawaCanadaUnknown status
SKIN Centre for Dermatology /ID# 200331
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PeterboroughCanadaUnknown status
Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403
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QuébecCanadaUnknown status
The Center For Dermatology /ID# 205409
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Richmond HillCanadaUnknown status
Dre Angelique Gagne-Henley M.D. inc. /ID# 200330
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Saint-JérômeCanadaUnknown status
Karma Clinical Trials /ID# 200339
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St. John'sCanadaUnknown status
Research Toronto /ID# 205410
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TorontoCanadaUnknown status
Toronto Research Centre /ID# 205411
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TorontoCanadaUnknown status
XLR8 Medical Research /ID# 205405
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WindsorCanadaUnknown status
Beijing Friendship Hospital /ID# 207434
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BeijingChinaUnknown status
Chinese PLA General Hospital /ID# 206786
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BeijingChinaUnknown status
Xiangya Hospital Central South University /ID# 207510
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ChangshaChinaUnknown status
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728
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GuangzhouChinaUnknown status
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132
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HangzhouChinaUnknown status
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442
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HangzhouChinaUnknown status
Huashan Hospital of Fudan University /ID# 207437
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ShanghaiChinaUnknown status
The First Hospital of China Medical University /ID# 209840
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ShenyangChinaUnknown status
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669
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WuhanChinaUnknown status
Sanatorium profesora Arenbergera
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Prague 1CzechiaActive, not recruiting
Vseobecna Fakultni Nemocnice V Praze
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Prague 2CzechiaActive, not recruiting
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
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Blankenfelde-MahlowGermanyActive, not recruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyActive, not recruiting
Klinikum Darmstadt GmbH
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DarmstadtGermanyActive, not recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyActive, not recruiting
Universitaetsklinikum Frankfurt AöR
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Frankfurt Am MainGermanyActive, not recruiting
TFS Trial Form Support GmbH
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HamburgGermanyActive, not recruiting
Medizinische Hochschule Hannover Service GmbH
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HanoverGermanyActive, not recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyActive, not recruiting
University Medical Centre Schleswig-Holstein
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KielGermanyActive, not recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyActive, not recruiting
Universitaetsklinikum Muenster AöR
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MuensterGermanyActive, not recruiting
Klinikum rechts der Isar der TU Muenchen AöR
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MunichGermanyActive, not recruiting
cms³ Company for Medical Study & Service Selters GmbH
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Selters (Westerwald)GermanyActive, not recruiting
Dermatologisches Studienzentrum Hunsrück
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SimmernGermanyActive, not recruiting
Hospital General Universitario Dr. Balmis
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AlicanteSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Consorci Mar Parc De Salut De Barcelona
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BarcelonaSpainActive, not recruiting
Hospital General Universitario Reina Sofia
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CórdobaSpainActive, not recruiting
Sant Joan De Deu Barcelona Hospital
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Esplugues De LlobregatSpainActive, not recruiting
Hospital Universitario Clínico San Cecilio
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GranadaSpainActive, not recruiting
Hospital Universitario de la Princesa
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MadridSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Universitario Infanta Leonor
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario De Puerto Real
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Puerto RealSpainActive, not recruiting
Hospital General Universitario de Valencia
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ValenciaSpainActive, not recruiting
Suomen Terveystalo Oy
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TampereFinlandActive, not recruiting
Hopital Prive D Antony
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AntonyFranceActive, not recruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceActive, not recruiting
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceActive, not recruiting
Centre Hospitalier Le Mans
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Le Mans Cedex 9FranceActive, not recruiting
Assistance Publique Hôpitaux de Marseille
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MarseilleFranceActive, not recruiting
Du Docteur Ruer S.E.L.A.R.L.
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MartiguesFranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceActive, not recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceActive, not recruiting
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceActive, not recruiting
Courlancy Sante
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ReimsFranceActive, not recruiting
CHU De Rouen
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Rouen CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceActive, not recruiting
Centre Hospitalier Régional Universitaire de Tours
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ToursFranceActive, not recruiting
NHS Tayside /ID# 202081
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DundeeUnited KingdomUnknown status
NHS Greater Glasgow and Clyde /ID# 201374
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GlasgowUnited KingdomUnknown status
Leeds Teaching Hospitals NHS Trust /ID# 201106
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LeedsUnited KingdomUnknown status
Guy's and St Thomas' NHS Foundation Trust /ID# 201193
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LondonUnited KingdomUnknown status
Guy's and St Thomas' NHS Foundation Trust /ID# 204642
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LondonUnited KingdomUnknown status
Barts Health NHS Trust /ID# 201044
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LondonUnited KingdomUnknown status
Oxford University Hospitals NHS Foundation Trust /ID# 202052
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OxfordUnited KingdomUnknown status
University General Hospital Attikon
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AthensGreeceActive, not recruiting
401 General Military Hospital of Athens
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AthensGreeceActive, not recruiting
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
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AthensGreeceActive, not recruiting
General Hospital Of Thessaloniki Papageorgiou
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EfkarpiaGreeceActive, not recruiting
Ippokratio General Hospital of Thessaloniki
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ThessalonikiGreeceActive, not recruiting
Prince of Wales Hospital /ID# 205152
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Hong KongHong KongUnknown status
Queen Mary Hospital /ID# 205146
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Hong KongHong KongUnknown status
Poliklinika Vlatka Cavka d.o.o.
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Grad ZagrebCroatiaActive, not recruiting
Klinika Za Djecje Bolesti Zagreb
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Grad ZagrebCroatiaActive, not recruiting
Poliklinika Dermaplus
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Grad ZagrebCroatiaActive, not recruiting
Djecja bolnica Srebrnjak
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Grad ZagrebCroatiaActive, not recruiting
NAFTALAN specijalna bolnica za medicinsku rehabilitaciju
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Ivanic-GradCroatiaActive, not recruiting
KBC Split
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SplitCroatiaActive, not recruiting
Clinexpert Kft.
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Budapest IIIHungaryActive, not recruiting
University of Debrecen
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DebrecenHungaryActive, not recruiting
Derma-B Kft.
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DebrecenHungaryActive, not recruiting
Gyöngyösi Bugát Pál Kórház
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GyongyosHungaryActive, not recruiting
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
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MiskolcHungaryActive, not recruiting
Dermamed Research Kft.
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OrosházaHungaryActive, not recruiting
University of Pecs
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PécsHungaryActive, not recruiting
University of Szeged
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SzegedHungaryActive, not recruiting
Allergo-Derm Bakos Kft
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SzolnokHungaryActive, not recruiting
South Infirmary Victoria University Hospital
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CorkIrelandActive, not recruiting
St James's Hospital
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Dublin 8IrelandActive, not recruiting
University Hospital Galway
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GalwayIrelandActive, not recruiting
University Hospital Waterford
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WaterfordIrelandActive, not recruiting
HaEmek Medical Center /ID# 201958
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AfulaIsraelUnknown status
Soroka University Medical Center /ID# 206652
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BeershebaIsraelUnknown status
Rabin Medical Center /ID# 201959
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Petah TikvaIsraelUnknown status
The Chaim Sheba Medical Center /ID# 201611
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Ramat GanIsraelUnknown status
Tel Aviv Sourasky Medical Center /ID# 201608
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Tel AvivIsraelUnknown status
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyActive, not recruiting
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
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L'aquilaItalyActive, not recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Di Cagliari
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MonserratoItalyActive, not recruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Humanitas Research Hospital
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RozzanoItalyActive, not recruiting
Hiramoto skin clinic /ID# 204048
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Amagasaki-shiJapanUnknown status
Juntendo University Hospital /ID# 202888
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Bunkyo-kuJapanUnknown status
Medical Corporation Matsuo Clinic /ID# 202312
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FukuokaJapanUnknown status
Osaka Habikino Medical Center /ID# 204243
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Habikino-shiJapanUnknown status
Tokai University Hachioji Hospital /ID# 201711
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Hachioji-shiJapanUnknown status
Hiroshima University Hospital /ID# 201914
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HiroshimaJapanUnknown status
Maruyama Dermatology Clinic /ID# 202350
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Koto-kuJapanUnknown status
Kyoto University Hospital /ID# 201654
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KyotoJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine /ID#258604
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KyotoJapanUnknown status
Chukyo Hospital /ID# 202311
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NagoyaJapanUnknown status
National Hospital Organization Sagamihara National Hospital /ID# 201658
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Sagamihara-shiJapanUnknown status
Medical Corporation Kojinkai Sapporo Skin Clinic /ID#258665
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SapporoJapanUnknown status
Tohoku University Hospital /ID# 206322
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SendaiJapanUnknown status
Jichi Medical University Hospital /ID# 201913
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Shimotsuke-shiJapanUnknown status
Yamate Dermatological Clinic /ID# 202130
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Shinjuku-kuJapanUnknown status
Queens Square Medical Center dermatology allergology /ID# 203850
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YokohamaJapanUnknown status
Academisch Medisch Centrum
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AmsterdamNetherlandsActive, not recruiting
Bravis Ziekenhuis
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Bergen op ZoomNetherlandsActive, not recruiting
University Medical Center Groningen
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GroningenNetherlandsActive, not recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsActive, not recruiting
University Medical Center Utrecht
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UtrechtNetherlandsActive, not recruiting
Helse Bergen HF
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BergenNorwayCompleted
Oslo University Hospital HF
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OsloNorwayCompleted
University Hospital Of North Norway HF
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TromsoeNorwayCompleted
Clinical Trials NZ /ID# 205336
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HamiltonNew ZealandUnknown status
Dr. Samuel Sanchez PSC /ID# 202002
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CaguasPuerto RicoUnknown status
Clinical Research Puerto Rico /ID# 203644
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San JuanPuerto RicoUnknown status
GCM Medical Group PSC - Hato Rey /ID# 202003
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San JuanPuerto RicoUnknown status
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalActive, not recruiting
Unidade Local De Saude Da Regiao De Leiria E.P.E.
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LeiriaPortugalActive, not recruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalActive, not recruiting
Hospital Cuf Descobertas S.A.
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LisbonPortugalActive, not recruiting
Unidade Local De Saude De Santo Antonio E.P.E.
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PortoPortugalActive, not recruiting
Unidade Local de Saude de Sao Joao E.P.E.
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PortoPortugalActive, not recruiting
Sahlgrenska University Hospital-Vastra Gotalandsregionen
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GoteborgSwedenActive, not recruiting
Karolinska University Hospital
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StockholmSwedenActive, not recruiting
Univerzitna nemocnica Martin
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MartinSlovakiaActive, not recruiting
Fakultna nemocnica s poliklinikou Nove Zamky
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Nové ZámkySlovakiaActive, not recruiting
Fakultna nemocnica s poliklinikou J.A. Reimana Presov
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PrešovSlovakiaActive, not recruiting
ORA, Inc. /ID# 202824
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AndoverUnited StatesUnknown status
Arlington Research Center, Inc /ID# 200559
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ArlingtonUnited StatesUnknown status
Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822
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AuroraUnited StatesUnknown status
Bakersfield Derma & Skin Cance /ID# 200892
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BakersfieldUnited StatesUnknown status
Mosaic Dermatology /ID# 200553
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Beverly HillsUnited StatesUnknown status
Bexley Dermatology Research /ID# 200899
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BexleyUnited StatesUnknown status
Total Skin and Beauty Derm Ctr /ID# 200548
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BirminghamUnited StatesUnknown status
Clinical Research Center AL /ID# 201865
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BirminghamUnited StatesUnknown status
ACCEL Research Sites /ID# 213364
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BirminghamUnited StatesUnknown status
Clearlyderm Dermatology /ID# 207709
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Boca RatonUnited StatesUnknown status
Skin Care Research, LLC /ID# 200812
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Boca RatonUnited StatesUnknown status
Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628
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BoiseUnited StatesUnknown status
Beth Israel Deaconess Medical Center /ID# 200545
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BostonUnited StatesUnknown status
Tufts Medical Center /ID# 200570
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BostonUnited StatesUnknown status
Colorado Center for Dermatology, PLLC /ID# 203626
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CentennialUnited StatesUnknown status
Clin Res Inst of Michigan, LLC /ID# 208020
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ChesterfieldUnited StatesUnknown status
Northwestern University Feinberg School of Medicine /ID# 201646
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ChicagoUnited StatesUnknown status
Michigan Center for Research Company /ID# 200560
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ClarkstonUnited StatesUnknown status
Clinical Research of West Florida, Inc /ID# 203643
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ClearwaterUnited StatesUnknown status
The Ohio State University /ID# 200542
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ColumbusUnited StatesUnknown status
Florida Academic Centers Research and Education /ID# 200544
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Coral GablesUnited StatesUnknown status
Psoriasis Treatment Center of Central New Jersey /ID# 200714
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East WindsorUnited StatesUnknown status
Deaconess Clinic Downtown /ID# 201001
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EvansvilleUnited StatesUnknown status
Rivergate Dermatology & Skin Care Center /ID# 201698
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GoodlettsvilleUnited StatesUnknown status
Center for Clinical Studies /ID# 200582
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HoustonUnited StatesUnknown status
Indiana University /ID# 200515
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IndianapolisUnited StatesUnknown status
University of California Irvine /ID# 200902
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IrvineUnited StatesUnknown status
Dartmouth-Hitchcock Medical Center /ID# 200918
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LebanonUnited StatesUnknown status
University of Wisconsin - Madison /ID# 204933
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MadisonUnited StatesUnknown status
Advanced Dermatology and Skin Care Centre /ID# 213550
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MobileUnited StatesUnknown status
Stones River Dermatology /ID# 204962
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MurfreesboroUnited StatesUnknown status
Juva Skin and Laser Center /ID# 200997
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New YorkUnited StatesUnknown status
Eastern Virginia Med School /ID# 200994
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NorfolkUnited StatesUnknown status
Tory P Sullivan, MD PA /ID# 201174
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North Miami BeachUnited StatesUnknown status
Skin Specialists, PC /ID# 200573
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OmahaUnited StatesUnknown status
Park Avenue Dermatology, PA /ID# 201012
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Orange ParkUnited StatesUnknown status
Epiphany Dermatology of Kansas LLC /ID# 203026
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Overland ParkUnited StatesUnknown status
Alliance Dermatology and MOHs Center, PC /ID#200540
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PhoenixUnited StatesUnknown status
Arizona Research Center, Inc. /ID# 200546
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PhoenixUnited StatesUnknown status
University of Pittsburgh MC /ID# 206057
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PittsburghUnited StatesUnknown status
Oregon Dermatology and Research Center /ID# 200601
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PortlandUnited StatesUnknown status
Rhode Island Hospital /ID# 200566
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ProvidenceUnited StatesUnknown status
MediSearch Clinical Trials /ID# 201006
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Saint JosephUnited StatesUnknown status
Advanced Clinical Research - Woseth Dermatology /ID# 213745
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Salt Lake CityUnited StatesUnknown status
Progressive Clinical Research /ID# 201582
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San AntonioUnited StatesUnknown status
Therapeutics Clinical Research /ID# 200593
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San DiegoUnited StatesUnknown status
Clear Dermatology & Aesthetics Center /ID# 201257
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ScottsdaleUnited StatesUnknown status
Dermatology Associates of Seattle /ID# 200717
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SeattleUnited StatesUnknown status
Dermatology Physicians of Connecticut /ID# 201004
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SheltonUnited StatesUnknown status
Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556
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SkokieUnited StatesUnknown status
Stanford University /ID# 200597
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StanfordUnited StatesUnknown status
Precision Clinical Research /ID# 208734
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SunriseUnited StatesUnknown status
J. Schwartz, MD, PLLC /ID# 202122
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TroyUnited StatesUnknown status
University of Arizona /ID# 201059
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TucsonUnited StatesUnknown status
Vital Prospects Clinical Research Institute, PC /ID# 200901
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TulsaUnited StatesUnknown status
AAPRI Clinical Research /ID# 221134
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WarwickUnited StatesUnknown status
Center for Clinical Studies - Webster TX /ID# 203186
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WebsterUnited StatesUnknown status
DuPage Medical Group /ID# 202065
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WheatonUnited StatesUnknown status
Duplicate_Western States Clinical Research, Inc. /ID# 201702
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Wheat RidgeUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.