A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis (APPLES)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00475605
First received: May 17, 2007
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were < 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.


Condition
Atopic Dermatitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • The endpoint is the occurrence of serious adverse events, including the observation of systemic and cutaneous malignancies [ Time Frame: At six month intervals for ten years ] [ Designated as safety issue: No ]

Enrollment: 8037
Study Start Date: May 2005
Estimated Study Completion Date: August 2022
Estimated Primary Completion Date: August 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts
1. Protopic Exposure
Pediatric subjects whose ages are/were <16 years at the time of first tacrolimus ointment exposure

Detailed Description:

Data will be collected at enrollment and every 6 months thereafter either by interview, Internet, or physician office visit. Each subject will be followed for 10 years in this study.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric subjects whose ages are/were <16 years at the time of first tacrolimus ointment exposure

Criteria

Inclusion Criteria:

  • Subjects who first used Protopic® 0.03% or 0.1% before they were sixteen years of age and were treated for at least 6 weeks for the treatment of Atopic dermatitis may enroll into the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475605

  Hide Study Locations
Locations
United States, Alabama
Shelby Dermatology
Albaster, Alabama, United States, 35007
Pediatric Care Center of NE Alabama
Anniston, Alabama, United States, 36207
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, United States, 35205
Skin Wellness Center of Alabama
Birmingham, Alabama, United States, 35209
Metro Pediatrics, P.C
Birmingham, Alabama, United States, 35209
Pediatric & Adult Asthma and Allergy, P.C.
Birmingham, Alabama, United States, 35209
Southview Dermatology
Birmingham, Alabama, United States, 35213
Ruth A Yates
Huntsville, Alabama, United States, 35801
United States, Arizona
Derma
Phoenix, Arizona, United States, 85048
Alliance Dermatology
Phoenix, Arizona, United States, 85032
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Hull Dermatology, P.A.
Rogers, Arkansas, United States, 72758
United States, California
Coastal Allergy Care
Camarillo, California, United States, 93010
Tien Nguyen
Fountain Valley, California, United States, 92708
Dermatology Research Associates
Los Angeles, California, United States, 90045
California Skin Institute
Mountain View, California, United States, 94040
Capital Allergy & Respiratory Disease Center
Sacramento, California, United States, 95819
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
Allergy and Immunology Clinic
San Diego, California, United States, 92111
California Dermatology Care
San Ramon, California, United States, 94583
United States, Connecticut
Connecticut Children's Medical Center Dept of Dermatology
Hartford, Connecticut, United States, 06106
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Delaware
Webster Dermatology, PA
Hockessin, Delaware, United States, 19707
Atlantic Skin & Cosmetic Surgery Group
Wilmington, Delaware, United States, 19810
United States, Florida
Center for Dermatology
Boca Raton, Florida, United States, 33428
Joshua Berlin P.A.
Boynton Beach, Florida, United States, 33437
Angelos Koutsonikolis, MD, PA
Boynton Beach, Florida, United States, 33437
Fort Lauderdale Dermatology & Cosmetic Skin Center
Fort Lauderdale, Florida, United States, 33308
North Florida Dermatology Associates, P.A.
Jacksonville, Florida, United States, 32204
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Tory Patrick Sullivan
N. Miami Beach, Florida, United States, 33162
Andrea Trowers, MD
North Miami, Florida, United States, 33181
Allergy Associates of the Palm Beaches, PA
North Palm Beach, Florida, United States, 33408
Orlando Dermatology
Orlando, Florida, United States, 32819
Donna Zeide
Palm Beach Gardens, Florida, United States, 33418
Dr.Robert A. Norman
Tampa, Florida, United States, 33626
Academic Alliance in Dermatology
Tampa, Florida, United States, 33615
United States, Georgia
Georgia Pollens Clinical Research Centers, Inc
Albany, Georgia, United States, 31707
Emory University
Atlanta, Georgia, United States, 30322
Dermatology Consultants PC
Covington, Georgia, United States, 30014
Dermatologic Surgery Specialist Inc.
Macon, Georgia, United States, 31217
MedaPhase,Inc.
Newnan, Georgia, United States, 30263
AeroAllergy Research Labs of Savannah, Inc.
Savannah, Georgia, United States, 31406
Southern Crescent Dermatology
Stockbridge, Georgia, United States, 30281
United States, Hawaii
Wayne Fujita, M.D. - Private Practice
Aiea, Hawaii, United States, 96701
Paul S. Takiguchi- MD- Inc.
Aiea, Hawaii, United States, 96701
United States, Idaho
Dermatology Clinic of Idaho
Boise, Idaho, United States, 83704
Southeast Idaho Family Practice
Idaho Falls, Idaho, United States, 83404
United States, Illinois
DermAssociates LTD
Belleville, Illinois, United States, 62226
Christie Clinic
Champaign, Illinois, United States, 61820
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Indiana
Dermatology, Inc.
Carmel, Indiana, United States, 46032
Shideler Clinical Research Center
Carmel, Indiana, United States, 46032
Dermatology Associates, PC
Indianapolis, Indiana, United States, 46240
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
The Dermatology Center
New Albany, Indiana, United States, 47150
Dermatology Center of Indiana P.C.
Plainfield, Indiana, United States, 46168
Randall Dermatology
West Lafayette, Indiana, United States, 47906
United States, Iowa
Clinton Urgent Care
Clinton, Iowa, United States, 52732
United States, Kansas
Kansas City Dermatology, PA
Overland Park, Kansas, United States, 66215
Midwest Dermatology
Overland Park, Kansas, United States, 66209
Kansas Medical Clinic, PA
Topeka, Kansas, United States, 66614
Mid-Kansas Dermatology Clinic, PA
Wichita, Kansas, United States, 67206
United States, Kentucky
Melissa Knuckles
Corbin, Kentucky, United States, 40701
Michael W. Simon, M.D.
Nicholasville, Kentucky, United States, 40356
United States, Louisiana
LA Dermatology Assoc LLC
Baton Rouge, Louisiana, United States, 70809
Dimitri Dermatology
Gretna, Louisiana, United States, 70056
Kids First Prytania
New Orleans, Louisiana, United States, 70115
All Kids Pediatrics of Opelousas APMC
Opelousas, Louisiana, United States, 70570
Highland Clinic
Shreveport, Louisiana, United States, 71105
Holliway Pediatric Clinic
Shreveport, Louisiana, United States, 71103
Healing Hands Family Medicine
Shreveport, Louisiana, United States, 71129
Wee Care Pediatrics & Kidmed Clinic
Shreveport, Louisiana, United States, 71107
United States, Maryland
Johns Hopkins University, Division of Pediatric Dermatolgy
Baltimore, Maryland, United States, 21287
Clarksburg Pediatrics, LLC
Clarksburg, Maryland, United States, 20871
Family Allergy & Asthma Care
Gaithersburg, Maryland, United States, 20878
Callender Skin and Laser Center
Glenn Dale, Maryland, United States, 20769
DermAssociates, PC
Silver Spring, Maryland, United States, 20902
Beverly Johnson, MD
Silver Springs, Maryland, United States, 20904
Robert S. Berger
White Plains, Maryland, United States, 20695
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Adult & Pediatric Dermatology
Marlborough, Massachusetts, United States, 01752
Kenneth M. Reed, MD
Quincy, Massachusetts, United States, 02169
United States, Michigan
Drs. Iacobelli & DiGregorio, PC
Clinton Township, Michigan, United States, 48038
Henry Ford Medical Center
Detroit, Michigan, United States, 48202
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
Silverton Skin Institute
Grand Blanc, Michigan, United States, 48439
SVC Dermatology PC
Sterling Heights, Michigan, United States, 48314
Somerset Skin Centre
Troy, Michigan, United States, 48084
Grekin Skin Institute
Warren, Michigan, United States, 48093
Midwest Center for Dermatology and Cosmetic Surgery
Warren, Michigan, United States, 48093
United States, Minnesota
Dermatology Center for Children and Young Adults
Eagan, Minnesota, United States, 55121
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
Asthma & Allergy Center of North Jackson
Jackson, Mississippi, United States, 39206
Peace Children's Clinic
Jackson, Mississippi, United States, 39216
United States, Missouri
North County Dermatology
Florissant, Missouri, United States, 63031
Kosse Pediatrics
Saint Joseph, Missouri, United States, 64506
United States, Nebraska
South Lincoln Dermatology Clinic
Lincoln, Nebraska, United States, 68502
Advanced Skin Research
Omaha, Nebraska, United States, 68144
United States, Nevada
Bettencourt Skin Center
Henderson, Nevada, United States, 89014
Aistheta
Reno, Nevada, United States, 89509
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cheryl D. Ackerman
Glen Ridge, New Jersey, United States, 07028
CDLC
Ridgewood, New Jersey, United States, 07450
The Dermatology Group, PC
Verona, New Jersey, United States, 07044
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Allergy & Asthma Associates of NNM
Los Alamos, New Mexico, United States, 87544
United States, New York
New York Dermatology, P.C.
Bayside, New York, United States, 11360
Robert S. Darr, MD, PC
Brooklyn, New York, United States, 11209
Morris Westfried, M.D.
Brooklyn, New York, United States, 11228
Garden City Dermatology, P.C.
Garden City, New York, United States, 11530
Hollis Medisys
Hollis, New York, United States, 11432
Marvin S.Watsky
Lindenhurst, New York, United States, 11757
Orange Dermatology Assoc, PC
Monroe, New York, United States, 10950
Columbia University Medical Center., Dept. of Medicine
New York, New York, United States, 10032
St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10025
Helendale Dermatology & Medical Spa, LLC
Rochester, New York, United States, 14609
Marina I Peredo, MD
Smithtown, New York, United States, 11787
Derm Research Center of New York, Inc.
Stony Brook, New York, United States, 11790
Joseph D. Sutton, MD
Suffern, New York, United States, 10901
Stanley A. Newfield
Valley Stream, New York, United States, 11581
United States, North Carolina
Davie Dermatology
Advance, North Carolina, United States, 27006
Alamance Skin Center
Burlington, North Carolina, United States, 27215
Pediatrx Clinic
Fayetteville, North Carolina, United States, 28305
Southeastern Dermatology, PA
Lumberton, North Carolina, United States, 28358
FMC/OIC
Rocky Mount, North Carolina, United States, 27801
Atlantic Dermatology Associates, P.A.
Wilmington, North Carolina, United States, 28401
Carolina Dermatology & Skin Cancer Surgery
Wilmington, North Carolina, United States, 28403
Knox Clinic Pediatrics, PLLC
Wilmington, North Carolina, United States, 28403
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Haber Dermatology and Cosmetic Surgery, Inc
Beachwood, Ohio, United States, 44122
Dermatology Research Associates, Inc.
Cincinnati, Ohio, United States, 45230
University Dermatology Consultants, Inc.
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Warren Dermatology & Allergy
Warren, Ohio, United States, 44484
United States, Oklahoma
Brian Lepley, D.O.
Oklahoma City, Oklahoma, United States, 73139
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
College of Osteopathic Med
Tulsa, Oklahoma, United States, 74127
United States, Pennsylvania
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, United States, 19034
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
East Penn Dermatology
North Wales, Pennsylvania, United States, 19454
Paddington Testing Co, Inc.
Philadelphia, Pennsylvania, United States, 19103
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Clinical Partners, LLC
Johnston, Rhode Island, United States, 02919
United States, South Carolina
National Allergy, Asthma & Urticaria Centers of Charleston, PA
Charleston, South Carolina, United States, 29406
Dermatology and Laser Center of Charleston
Charleston, South Carolina, United States, 29414
Cheraw Pediatrics, P.A.
Cheraw, South Carolina, United States, 29520
Dermatology Group LLC
Columbia, South Carolina, United States, 29201
McClerklin Skin and Laser Center
Columbia, South Carolina, United States, 29203
Allergic Disease & Asthma Center
Greenville, South Carolina, United States, 29406
Palmetto Skin & Laser Center
Rock Hill, South Carolina, United States, 29732
United States, Tennessee
The Asthma Institute PLLC
Chattanooga, Tennessee, United States, 37421
Rivergate Dermatology Research Center
Goodlettsville, Tennessee, United States, 37072
Dermatology Associates of Kingsport, PC
Kingsport, Tennessee, United States, 37660
Dermatology Associates of Knoxville, PC
Knoxville, Tennessee, United States, 37917
Allergy Associates, PA dba East Tennessee Center for Clinical Research
Knoxville, Tennessee, United States, 37909
The Skin Wellness Center
Knoxville, Tennessee, United States, 37922
Sheffield Pediatrics, PLLC
Memphis, Tennessee, United States, 38104
Raleigh Group PC
Memphis, Tennessee, United States, 38128
United States, Texas
Arlington Center for Dermatology
Arlington, Texas, United States, 76011
Academy of Clinical Research
Arlington, Texas, United States, 76011
Zoltan Trizna
Austin, Texas, United States, 78759
Pediatric Allergy/Immunology Associates
Dallas, Texas, United States, 75230
Pushpa R. Rana M.D. P.A.
Dallas, Texas, United States, 75217
Dermatology Treatment and Research Center, PA
Dallas, Texas, United States, 75230
Western Sky Medical Research
El Paso, Texas, United States, 79903
North Texas Institute for Clinical Trials
Fort Worth, Texas, United States, 76132
University of N. Texas Health Science Center
Fort Worth, Texas, United States, 76107
Dermatology Center of Frisco
Frisco, Texas, United States, 75035
Pediatric Dermatology of North Texas PA
Grapevine, Texas, United States, 76051
Stephen Schwartz
Harlingen, Texas, United States, 78550
Bear Creek Clinic, PA
Houston, Texas, United States, 77084
Lone Star Children's Medical PLLC
Houston, Texas, United States, 77092
West Houston Dermatology, PA
Houston, Texas, United States, 77082
University of Texas - Houston
Houston, Texas, United States, 77030
Heights Dermatology & Aesthetic Center
Houston, Texas, United States, 77008
Dermatology and Laser Center
Irving, Texas, United States, 75061
Lubbock Dermatology and Skin Cancer Center
Lubbock, Texas, United States, 79410
Rick Lin, D.O., MPH
McAllen, Texas, United States, 78504
Pasadena Dermatology Clinic
Pasadena, Texas, United States, 77506
Medical Research Network
Spring, Texas, United States, 77373
Trinity Clinic, Pediatrics
Tyler, Texas, United States, 75702
United States, Utah
Dermatology Research Center
Salt Lake City, Utah, United States, 84117
United States, Vermont
Brookside Pediatrics
Bennington, Vermont, United States, 05201
United States, Virginia
Glenn H. Fuchs, MD PC
Arlington, Virginia, United States, 22204
Dermatology Assoc of Northern Vineland
Centreville, Virginia, United States, 20121
Piedmont Dermatology Center, PC
Martinsville, Virginia, United States, 24112
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Children's Hospital of the Kings Daughters
Norfolk, Virginia, United States, 23507
United States, Washington
Dermatology Associates, PLLC
Seattle, Washington, United States, 98101
Asthma, Inc.
Seattle, Washington, United States, 98105
Eastern Washington Dermatology
Walla Walla, Washington, United States, 99362
United States, Wisconsin
Univeristy of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
George V. Chandy MD SC
Milwaukee, Wisconsin, United States, 53208
United States, Wyoming
Central Wyoming Skin Clinic
Casper, Wyoming, United States, 82609
Austria
LKH Feldkirch
Feldkirch, Austria, 6807
Landesfrauen- und -kinderklinik
Linz, Austria, 4020
Salzburger Landeskliniken
Salzburg, Austria, 5020
Canada, Manitoba
Winnipeg Clinic
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, Newfoundland and Labrador
NewLab Clinical Research, Inc.
St John's, Newfoundland and Labrador, Canada, A1C 2H5
Nexus Clinical Research
St Johns, Newfoundland and Labrador, Canada, A1A 5E8
Canada, Nova Scotia
Eastern Canada Cutaneous Research Association
Halifax, Nova Scotia, Canada, B3H 1Z4
Canada, Ontario
Mediprobe Research, Inc.
London, Ontario, Canada, N5X 2P1
Lynderm Research, Inc.
Markham, Ontario, Canada, L3P 1A8
Sudbury Skin Clinic
Sudbury, Ontario, Canada, P3E 5M4
France
Cabinet Medical
Amiens, France, 80090
Hopital Pellegrin
Bordeaux, France, 33000
Cabinet de Dermatologie - Boulogne
Boulogne, France, 92100
Cabinet de Dermatologie - Boulogne-Sur-Mer
Boulogne, France, 62200
Hopital Augustin Morvan
Brest Cedex 2, France, 29609
Cabinet de dermatologie - Cannes
Cannes, France, 06400
Hopital Trousseau
Chambray Les Tours Cedex, France, 37171
Polyclinique du Cotentin
Equeurdreville, France, 50120
Centre Hospitalier
Le Mans Cedex, France, 72037
Hopital Claude Huriez
Lille Cedex, France, 59037
Cabinet de Dermatologie - Martigues
Martigues, France, 13500
Cabinet Dermatologie
Nantes, France, 44100
Hopital de l'Hotel Dieu
Nantes Cedex 1, France, 44093
Cabinet de Dermatologie
Nice, France, 06000
Cabinet de Dermatologie - Paris
Paris, France, 75007
Hospital Saint Louis
Paris Cedex 10, France, 75475
Hospital Necker
Paris Cedex 15, France, 75743
CHU La MILETRIE Service de Dermatologie
Poitiers Cedex, France, 86021
HOPITAL CHARLES NICOLLE Service de Dermatologie
Rouen Cedex, France, 76031
Hopital Nord
St. Priest En Jarez Cedex, France, 42277
Cabinet de Dermatologie-Strasbourg
Strasbourg, France, 67000
Cabinet de Dermatologie
Thann, France, 68800
Hopital Larrey
Toulouse Cedex 9, France, 31059
Centre Hospitalier Service de Dermatologie
Troyes Cedex, France, 10003
Germany
Licca Clinical Research Institute
Augsburg, Germany, 86179
Herr Dr. med Lutz Bellingrath, Kinderheilkunde
Bamberg, Germany, 96050
Garbe, Florian Hautartzt
Berlin, Germany, 13597
Wildfeuer,Thomas
Berlin, Germany, 13055
Charite - Universitaetsmedizin Berlin Klinik fuer Dermatologie, Venerologie u. Allergologie
Berlin, Germany, 10117
Klinik fuer Kinder u. Jugendmedizin der Ruhr Universitaet Bochum im St.-Josef-Hospital
Bochum, Germany, 44791
Universitaet Bonn Klinik und Poliklinik fuer Dermatologie
Bonn, Germany, 53105
Hermann, Hautarztpraxis
Bremen, Germany, 28239
Schwichtenberg, Uwe
Bremen, Germany, 28779
Dermatologisches Zentrum Buxtehude
Buxtehude, Germany, 21614
Hautarztpraxis Pfennig
Crimmitschau, Germany, 08451
Heidlas, Hautarzt
Dessau, Germany, 06842
Gerlach, Beatrice
Dresden, Germany, 01097
Arztpraxis fuer Hautkrankheiten
Dresden, Germany, 01169
Klinik und Poliklinik für Dermatologie Unviversitätsklinikum Dresden
Dresden, Germany, 01307
Hautklinik
Duesseldorf, Germany, 40225
Heinrich-Heine-Universitaet Hautklinik
Duesseldorf, Germany, 40225
Falker, Gernot
Frankenberg, Germany, 35066
Universitaetsklinikum Klinische Forschung, Zentrum d. Dermatologie u. Venerologie
Frankfurt, Germany, 60590
Derma-Study-Center-Friedrichshafen
Friedrichshafen, Germany, 88045
Hautarztpraxis
Gelnhausen, Germany, 63571
SRH Wald-Klinikum Gera GmbH
Gera, Germany, 07548
Kath. Kinderkrankenhaus Wilhelmstift
Hamburg, Germany, 22149
Klinische Forschung Hannover-Mitte GmbH
Hannover, Germany, 30159
Brinkmann, Hautarztpraxis
Herborn, Germany, 35745
Facharzt fuer Kinder-und Jugendmedizin
Hueckeswagen, Germany, 42499
Hautarztpraxis Sempell
Itzehoe, Germany, 25524
Klinikum der Fr.-Schiller-Universitaet
Jena, Germany, 07743
Christian-Albrechts-Universitaet zu Kiel
Kiel, Germany, 24105
Tagesklinik fuer Allergie und Hautkrankheiten
Kiel, Germany, 24148
Klinik fuer Dermatologie, Venerologie u. Allergologie
Leipzig, Germany, 04103
Kinderklinik und -poliklinik der Johannes-Gutenberg Universitaet Mainz
Mainz, Germany, 55101
Universitaetsklinikum Giessen+ Marburg Dermatolgie und Allergologie
Marburg, Germany, 35037
Praxis Dermatologie
Marburg, Germany, 35037
Schulze, Ina
Markkleeberg, Germany, 04416
Kinder- und Jugendaertzin
Moenchengladbach, Germany, 41066
Ludwig - Maximilians Universitaet, Klinik u. Poliklinik fuer Dermatologie u. Allergologie
Muenchen, Germany, 80337
Fellner von Feldegg, Philip
Muenster, Germany, 48163
Universitaetsklinikum Muenster, Klinik & Poliklinik Fuer Hautkrankheiten
Muenster, Germany, 48149
Proinnovera GmbH
Muenster, Germany, 48155
Krausse, Torsten
Riesa, Germany, 01589
Richter - Fachaerztin fuer Kinder- und Jugendmedizin
Solingen, Germany, 42697
Termeer, Christian
Stuttgart, Germany, 70499
Universitaets-Hautklinik Tuebingen
Tuebingen, Germany, 72076
Marienhospital Wesel
Wesel, Germany, 46483
Kinderarztpraxis
Wesseling, Germany, 50389
Hautarzt
Wusterwitz, Germany, 14789
Ireland
South Infirmary
Cork, Ireland
The Park Clinic
Dublin, Ireland, 18
Our Lady's Hospital for Sick Children
Dublin, Ireland, 12
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Universitair Medisch Centrum St. Radboud
Nijmegen, Netherlands, 6525 GA
Poland
Poradnia Alergologiczna Przychodni Przyszpitalnej Wojewodzkiego Szpitala Dzieciecego
Bydgoszcz, Poland, 85-087
Prywatna Praktyka Lekarska "Alergomed"
Bydgoszcz, Poland, 85-077
Szpital Dzieciecy Specjalistyczny Z.O.Z. nad Matka i Dzieckiem
Gdansk-Oliwa, Poland, 80-308
Praktyka Lekarska
Gostynin, Poland, 09-500
SPZOZ Szpital Specjalistyczny im. S. Zeromskiego
Krakow, Poland, 31-913
NZOZ Centrum Alergologii
Lodz, Poland, 90-553
Przychodnia Lekarski MED POL s.c.
Lodz, Poland, 92-202
Dermoklinika
Lodz, Poland, 90-436
Alergovita
Lublin, Poland, 20-803
Indywidualna Specjalistyczna Praktyka Lekarska
Sierpc, Poland, 09-200
NZOZ Przychodnia Dermatologiczna DERMED s.c
Torun, Poland, 87-100
United Kingdom
Amersham Hospital, Department of Dermatology
Amersham, United Kingdom, HP7 0JD
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
Royal Bolton Hospitals Trust
Bolton, United Kingdom, BL4 0JR
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 2QQ
Wales College of Medicine, Cardiff University, Heath Park
Cardiff, United Kingdom, CF14 4XN
Ninewells Hospital and Medical School
Dundee, United Kingdom, DD1 9SY
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH3 9YW
Harrogate & District Foundation NHS Trust Hospital
Harrogate, United Kingdom, HG2 7SX
Leeds General Infirmary, Dept of Dermatology
Leeds, United Kingdom, LS1 3EX
Royal Free Hospital
London, United Kingdom, NW3 2QG
Department of Pediatric Allergy and Immunology
Manchester, United Kingdom, M13 9WL
Chase Farm Hospital
Middlesex, United Kingdom, EN2 8JL
George Eliot Hospital
Nuneaton, United Kingdom, CV10 7DJ
University of Manchester, Dermatology-Pharmacology Unit Hope Hospital
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00475605     History of Changes
Other Study ID Numbers: F506-CL-5801, FG506-06-37, 03-0-161
Study First Received: May 17, 2007
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
Protopic Ointment
tacrolimus ointment
atopic dermatitis
child

Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014