Long-Term PF-06651600 for the Treatment of Alopecia Areata
Study Purpose
This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug. A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 12 Years and Over |
Gender | All |
Inclusion Criteria- For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:
- - Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss.
- - De novo participants >=12 to <18 years of age: >=50% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis.
- - De novo participants >=18 years of age and participants from Study B7931005 or B7981015 with >30 days between first visit in B7981032 and last dose in the prior study: >=25% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis.
- - No evidence of terminal scalp hair regrowth within 6 months (de novo only) - Current episode of terminal scalp hair loss <=10 years (de novo only) Exclusion Criteria- For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study: - Hearing loss with progression over previous 5 years, or sudden hearing loss, or middle or inner ear disease, or other auditory condition that is considered acute, fluctuating or progressive.
- - History of or current malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- - History of a single episode of disseminated herpes zoster or disseminated herpes simplex, or a history of more than one episode of localized, dermatomal herpes zoster.
- - Infection requiring hospitalization, or parenteral antimicrobial therapy within 6 months prior to Day 1.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04006457 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Pfizer |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Pfizer CT.gov Call Center |
Principal Investigator Affiliation | Pfizer |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Active, not recruiting |
Countries | Argentina, Australia, Canada, Chile, China, Colombia, Czechia, Germany, Japan, Korea, Republic of, Mexico, Poland, Russian Federation, Spain, Taiwan, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Alopecia Areata |
Study Website: | View Trial Website |
Arms
Experimental: Treatment sequence 1
Participants who did not previously receive study intervention in either study B7931005 or B7981015 will receive 200 milligrams (mg) PF-06651600, given as four 50 mg tablets once daily (QD) for 1 month, followed by 50 mg PF-06651600 tablet or capsule given QD for 59 months. Patients participating in the vaccine sub-study will receive the 2 vaccines or one of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 9 visit and prior to or on the Month 56 visit of the main B7981032 study.
Experimental: Treatment sequence 2
Participants who previously received study intervention in either study B7931005 or B7981015 will receive 50 mg PF-06651600 tablet or capsule given QD for 59 months. Patients participating in the vaccine sub-study will receive the 2 vaccines or 1 of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 6 visit and prior to or on the Month 56 visit of the main B7981032 study.
Interventions
Drug: - PF-06651600
50 mg oral tablets/capsules
Biological: - Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine
Single intramuscular injection administered to patients participating in the vaccine sub-study
Biological: - Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
Single intramuscular injection administered to patients participating in the vaccine sub-study
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
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The University of Alabama at Birmingham Hosptial Outreach Lab
Birmingham, Alabama, 35233
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The University of Alabama at Birmingham
Birmingham, Alabama, 35233
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The University of Alabama at Birmingham, Department of Dermatology
Birmingham, Alabama, 35294
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Mosaic Dermatology
Beverly Hills, California, 90211
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Univ of California, Irvine, Dermatology Clinical Research Center
Irvine, California, 92697
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Dermatology Specialists Inc.
Murrieta, California, 92562
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University of California, San Francisco
San Francisco, California, 94115
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Kaiser Permanente Clinical Trials Unit
San Francisco, California, 94118
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Southern California Dermatology, Inc.
Santa Ana, California, 92701
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
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University of Colorado Hospital Clinical and Translational Research Center
Aurora, Colorado, 80045
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University of Colorado Hospital Outpatient Pavilion
Aurora, Colorado, 80045
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Yale School of Medicine
New Haven, Connecticut, 06510
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Investigational Drug Services
New Haven, Connecticut, 06511
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Yale School of Medicine, Yale Center for Clinical Investigations
New Haven, Connecticut, 06519
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Yale School of Medicine, Yale Center for Clinical Investigation
New Haven, Connecticut, 06519
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Medstar Georgetown University Hospital - Department of Otolaryngology
Washington, District of Columbia, 20007
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Medstar Georgetown University Hospital-Dept of Otolaryngology
Washington, District of Columbia, 20007
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Medstar Washington Hospital Center-Claude Nogay Research Pharmacy
Washington, District of Columbia, 20010
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MedStar Washington Hospital Center
Washington, District of Columbia, 20010
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Medstar Georgetown University Hospital - Department of Pediatrics
Washington, District of Columbia, 20016
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Siperstein Dermatology Group
Boynton Beach, Florida, 33472
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Park Avenue Dermatology
Orange Park, Florida, 32073
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ForCare Clinical Research
Tampa, Florida, 33613
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Velocity Clinical Research - Boise
Meridian, Idaho, 83642
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Northwestern Medical Group
Chicago, Illinois, 60611
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Northwestern Medicine Diagnostic Testing Center
Chicago, Illinois, 60611
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Northwestern Medicine
Chicago, Illinois, 60611
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Northwestern Memorial Hospital Investigational Drug Service Pharmacy
Chicago, Illinois, 60611
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Northwestern Memorial Hospital
Chicago, Illinois, 60611
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Summit Dermatology and Aesthetic Surgery (in c/o TrialSpark, Inc)
Oakbrook Terrace, Illinois, 60181
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NorthShore University HealthSystem Dermatology Clinical Trials Unit
Skokie, Illinois, 60077
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Northshore University HealthSystem/Dermatology
Skokie, Illinois, 60077
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Southern Illinois University School of Medicine
Springfield, Illinois, 62702
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Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
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Medstar Georgetown University Hospital - Department of Dermatology
Chevy Chase, Maryland, 20815
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Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)
Boston, Massachusetts, 02114
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University of Minnesota Clinical Research Unit (CRU)
Minneapolis, Minnesota, 55455
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University of Minnesota Lillehei Clinical Research Unit (LCRU)
Minneapolis, Minnesota, 55455
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University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette Luke
Minneapolis, Minnesota, 55455
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Skin Specialists PC
Omaha, Nebraska, 68144
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Schweiger Dermatology, P.C.
Verona, New Jersey, 07044
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NYU School of Medicine, The Ronald O. Perelman Department of Dermatology
New York, New York, 10016
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Pura Dermatology (in c/o TrialSpark, Inc)
New York, New York, 10018
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029
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UNC CTRC
Chapel Hill, North Carolina, 27514
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UNC Hospitals, Investigational Drug Service
Chapel Hill, North Carolina, 27514
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UNC Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, 27516
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UNC Dermatology Clinical Trials Unit
Chapel Hill, North Carolina, 27516
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195
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Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136
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Oregon Medical Research Center
Portland, Oregon, 97201
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Oregon Medical Research Center
Portland, Oregon, 97223
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The University of Texas Health Science Center at Houston
Bellaire, Texas, 77401
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Tamjidi Skin Institute (in c/o TrialSpark, Inc)
Vienna, Virginia, 22182
International Sites
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CINME Centro de Investigaciones Metabolicas
Caba, Buenos Aires, C1027AAP
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Psoriahue Medicina Interdisciplinaria
Caba, , C1425DKG
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Address
Premier Specialists Pty Ltd
Kogarah, New South Wales, 2217
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St George Dermatology & Skin Cancer Centre
Kogarah, New South Wales, 2217
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The Skin Centre
Benowa, Queensland, 4217
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Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102
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Skin Health Institute
Carlton, Victoria, 3053
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Sinclair Dermatology
East Melbourne, Victoria, 3002
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Royal Melbourne Hospital, Melbourne Health
Parkville, Victoria, 3050
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Royal Melbourne Hospital
Parkville, Victoria, 3050
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Royal Melbourne Hospital, Melbourne Health
Parkville, Victoria, 3052
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Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4
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Eastern Canada Cutaneous Research Associates Ltd.
Halifax, Nova Scotia, B3H 1Z2
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Guenther Research Inc
London, Ontario, N6A 3H7
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Lynderm Research Inc.
Markham, Ontario, L3P 1X2
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Lynderm Research Inc.
Markham, Ontario, L3P 1X3
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The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5
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SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2
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York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, L4C 9M7
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Medicor Research Inc
Sudbury, Ontario, P3A 1W8
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Medicor Research Inc
Sudbury, Ontario, P3C 1X3
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Sudbury Skin Clinique
Sudbury, Ontario, P3C 1X8
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Research Toronto
Toronto, Ontario, M4W 2N2
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Research Toronto
Toronto, Ontario, M4W 2N4
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Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1
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Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Quebec, , G1V 4X7
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Centro Medico Skin Med
Santiago, LAS Condes, 7580206
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Centro Internacional de Estudios Clinicos - CIEC
Santiago, Recoleta, 8420383
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Medical Skin Center
Vina del Mar, Valparaiso, 2530900
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Clinica Dermacross S.A.
Santiago, Vitacura, 7640881
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing, 100050
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Peking University Third Hospital
Beijing, Beijing, 100191
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The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
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The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, 518053
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
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The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
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Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, 200025
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The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
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Fundacion Centro de Investigacion Clinica CIC
Medellin, Antioquia, 050001
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Fundacion Hospitalaria San Vicente de Paul
Medellin, Antioquia, 050010
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Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
Bogota D.C., , 110221
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DERMAMEDICA s.r.o.
Nachod, , 547 01
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Fakultni nemocnice Olomouc
Olomouc, , 779 00
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Clintrial s.r.o.
Praha 10, , 100 00
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Sanatorium profesora Arenbergera
Praha 1, , 110 00
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Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, 48455
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Fachklinik Bad Bentheim
Bad Bentheim, , 48455
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Emovis GmbH
Berlin, , 10629
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Universitaetsklinikum Erlangen
Erlangen, , 91054
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University Hospital Frankfurt
Frankfurt am Main, , 60590
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University Hospital Schleswig-Holstein
Luebeck, , 23538
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University Hospital Muenster
Muenster, , 48149
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Nagoya City University Hospital
Nagoya, Aichi, 467-8602
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Tohoku University Hospital
Sendai, Miyagi, 980-8574
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Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
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Juntendo Tokyo Koto Geriatric Medical Center
Koto-ku, Tokyo, 136-0075
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Kyorin University Hospital
Mitaka-shi, Tokyo, 181-8611
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Osaka Metropolitan University Hospital
Osaka, , 545-8586
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Tokyo Medical University Hospital
Tokyo, , 160-0023
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Pusan National University Hospital
Busan, , 49241
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Seoul National University Hospital
Seoul, , 03080
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Sociedad de Metabolismo y Corazon S.C.
Veracruz, , 91900
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Hospital D Maria
Veracruz, , 91910
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Address
Twoja Przychodnia SCM
Szczecin, Zachodniopomorskie, 71-500
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McBk S.C.
Grodzisk Mazowiecki, , 05-825
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Centermed Krakow Sp.z o.o.
Krakow, , 31-530
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Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak
Lodz, , 90-436
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Dermedic Jacek Zdybski
Ostrowiec Swietokrzyski, , 27-400
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Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, , 71-434
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RCMed Oddzial Warszawa
Warszawa, , 00-892
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Magdalena Opadczuk Carpe Diem Centrum Medycyny Estetycznej
Warszawa, , 02-661
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ETG Warszawa
Warszawa, , 02-793
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Royalderm Agnieszka Nawrocka
Warszawa, , 02-962
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EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej we Wroclawiu
Wroclaw, , 50-220
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Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
Wroclaw, , 50-566
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Centrum Medyczne OPOROW
Wroclaw, , 52-416
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State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Dermatovenerologic Dispensary"
Chelyabinsk, , 454092
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University Clinic of Kirov SMU
Kirov, , 610035
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Clinical Medical Center of Moscow State University of Medicine and Dentistry
Moscow, , 111398
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Federal State Autonomous Institution "National Medical Research Centre of Children's' Health"
Moscow, , 119991
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State Budgetary Institution of the Rostov Region "Dermatovenerologic Dispensary"
Rostov-on-Don, , 344002
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Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic"
Saint Petersburg,, , 191123
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Limited Liability Company "Centre Vitiligo" ("Centre Vitiligo" LLC)
Saint Petersburg, , 191123
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Address
Saint Petersburg State Budgetary Healthcare Institution "Dermatovenerologic Dispensary No. 10 -
Saint Petersburg, , 194021
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State Autonomous Healthcare Institution of the Yaroslavl Region "Clinical Emergency Hospital
Yaroslavl, , 150003
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Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
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Hospital del Mar
Barcelona, , 08003
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Hospital Universitario Reina Sofia
Cordoba, , 14004
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Hospital Universitario Infanta Leonor
Madrid, , 28031
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Hospital Universitario La Paz: Servicio de Farmacia
Madrid, , 28046
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Hospital Universitario La Paz
Madrid, , 28046
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Hospital Universitario y Politecnico La Fe
Valencia, , 46026
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Chung-Shan Medical University Hospital
Taichung, R.o.c., 40201
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Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , 83301
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, , 807
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Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, , 23561
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National Taiwan University Hospital
Taipei, , 100
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Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan City, , 333
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University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO14 0YG
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University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
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University Hospitals Sussex NHS Foundation Trust (UHSussex)
Brighton, , BN2 1ES
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NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital
Glasgow, , G51 4TF
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Guy's and St Thomas Hospitals NHS Foundation Trust, St Thomas Hospital
London, , SE1 7EH
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Guy's and St Thomas' Hospitals NHS Foundation Trust, St Thomas' Hospital
London, , SE1 7EH
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Guy's and St Thomas' Hospitals NHS Foundation Trust, Guy's Hospital
London, , SE1 9RT