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

APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis

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.

Study Overview

• Status: Terminated
• Conditions: Atopic Dermatitis

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.

• Study Type: Observational
• Enrollment (Actual): 8071

Contacts and Locations

Study Locations

• Austria
  • Feldkirch, Austria, 6807
    • LKH Feldkirch
  • Linz, Austria, 4020
    • Landesfrauen- und -kinderklinik
  • Salzburg, Austria, 5020
    • Salzburger Landeskliniken
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • Winnipeg Clinic
  • Newfoundland and Labrador
    • St John's, Newfoundland and Labrador, Canada, A1C 2H5
      • NewLab Clinical Research, Inc.
    • St Johns, Newfoundland and Labrador, Canada, A1A 5E8
      • Nexus Clinical Research
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1Z2
      • Eastern Canada Cutaneous Research Association
  • Ontario
    • London, Ontario, Canada, N5X 2P1
      • Mediprobe Research, Inc.
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research, Inc.
    • Sudbury, Ontario, Canada, P3E 5M4
      • Sudbury Skin Clinic
• France
  • Amiens, France, 80090
    • Cabinet Médical
  • Bordeaux, France, 33000
    • Hôpital Pellegrin
  • Boulogne, France, 62200
    • Cabinet de Dermatologie - Boulogne-Sur-Mer
  • Boulogne, France, 92100
    • Cabinet de Dermatologie - Boulogne
  • Brest Cedex 2, France, 29609
    • Hopital Augustin Morvan
  • Cannes, France, 06400
    • Cabinet de dermatologie - Cannes
  • Chambray Les Tours Cedex, France, 37171
    • Hôpital Trousseau
  • Le Mans Cedex, France, 72037
    • Centre Hospitalier
  • Lille Cedex, France, 59037
    • Hôpital Claude Huriez
  • Martigues, France, 13500
    • Cabinet de Dermatologie - Martigues
  • Nantes, France, 44100
    • Cabinet Dermatologie
  • Nantes Cedex 1, France, 44093
    • Hopital de l'Hotel Dieu
  • Nice, France, 06000
    • Cabinet de Dermatologie
  • Paris, France, 75007
    • Cabinet de Dermatologie - Paris
  • Paris Cedex 10, France, 75475
    • Hospital Saint Louis
  • Paris Cedex 15, France, 75743
    • Hospital Necker
  • Poitiers Cedex, France, 86021
    • CHU La MILETRIE Service de Dermatologie
  • Rouen Cedex, France, 76031
    • HOPITAL CHARLES NICOLLE Service de Dermatologie
  • St. Priest En Jarez Cedex, France, 42277
    • Hôpital Nord
  • Strasbourg, France, 67000
    • Cabinet de Dermatologie-Strasbourg
  • Thann, France, 68800
    • Cabinet de Dermatologie
  • Toulouse Cedex 9, France, 31059
    • Hôpital Larrey
  • Troyes Cedex, France, 10003
    • Centre Hospitalier Service de Dermatologie
  • Équeurdreville-Hainneville, France, 50120
    • Polyclinique Du Cotentin
• Germany
  • Augsburg, Germany, 86179
    • Licca Fachklinik f. aesthetisch- operative Dermatologie und Chirurgie
  • Bamberg, Germany, 96050
    • Kinderarztpraxis
  • Berlin, Germany, 10117
    • Charite - Universitaetsmedizin Berlin Klinik fuer Dermatologie, Venerologie u. Allergologie
  • Berlin, Germany, 13055
    • Hautarztpraxis
  • Berlin, Germany, 13597
    • Hautarztpraxis
  • Bochum, Germany, 44791
    • Klinik fuer Kinder u. Jugendmedizin der Ruhr Universitaet Bochum im St.-Josef-Hospital
  • Bonn, Germany, 53105
    • Universitaet Bonn Klinik und Poliklinik fuer Dermatologie
  • Bremen, Germany, 28239
    • Hautarztpraxis
  • Bremen, Germany, 28779
    • Hautarztpraxis
  • Buxtehude, Germany, 21614
    • Dermatologisches Zentrum Buxtehude
  • Crimmitschau, Germany, 08451
    • Hautarztpraxis
  • Dessau, Germany, 06842
    • Hautarztpraxis
  • Dresden, Germany, 01097
    • Hautarztpraxis
  • Dresden, Germany, 01169
    • Arztpraxis fuer Hautkrankheiten
  • Dresden, Germany, 01307
    • Klinik und Poliklinik f. Dermatologie Universitaetsklinikum Dresden
  • Duesseldorf, Germany, 40225
    • Hautklinik
  • Duesseldorf, Germany, 40225
    • Heinrich-Heine-Universitaet Hautklinik
  • Erlangen, Germany, 91054
    • Hautklinik des Universitaetsklinikums Erlangen
  • Frankenberg, Germany, 35066
    • Falker, Gernot, Hautarztpraxis
  • Frankfurt, Germany, 60590
    • Universitaetsklinikum Klinische Forschung, Zentrum d. Dermatologie u. Venerologie
  • Friedrichshafen, Germany, 88045
    • Derma-Study-Center-Friedrichshafen
  • Gelnhausen, Germany, 63571
    • Hautarztpraxis
  • Gera, Germany, 07548
    • SRH Wald-Klinikum Gera GmbH
  • Hamburg, Germany, 22149
    • Kath. Kinderkrankenhaus Wilhelmstift
  • Hannover, Germany, 30159
    • Klinische Forschung Hannover-Mitte GmbH
  • Herborn, Germany, 35745
    • Brinkmann, Hautarztpraxis
  • Itzehoe, Germany, 25524
    • Hautarztpraxis Sempell
  • Jena, Germany, 07743
    • Klinikum der Fr.-Schiller-Universitaet
  • Kiel, Germany, 24105
    • Universitaet Hautklinik Kiel
  • Kiel, Germany, 24148
    • DermaKiel-Hautarztpraxis
  • Leipzig, Germany, 04103
    • Klinik fuer Dermatologie, Venerologie u. Allergologie
  • Mainz, Germany, 55131
    • Johannes-Gutenberg Universitaet
  • Marburg, Germany, 35034
    • Universitaetsklinikum Giessen+ Marburg Dermatolgie und Allergologie
  • Marburg, Germany, 35037
    • Praxis Dermatologie
  • Markkleeberg, Germany, 04416
    • Hautarztpraxis
  • Moenchengladbach, Germany, 41066
    • Kinder- und Jugendaertzin
  • Muenchen, Germany, 80337
    • Ludwig - Maximilians Universitaet, Klinik u. Poliklinik fuer Dermatologie u. Allergologie
  • Muenster, Germany, 48149
    • Universitaetsklinikum Muenster, Klinik & Poliklinik Fuer Hautkrankheiten
  • Muenster, Germany, 48155
    • Proinnovera GmbH
  • Muenster, Germany, 48163
    • Facharzt f. Kinder-und Jugendmedizin
  • Ravensburg, Germany, 88212
    • Facharzt fuer Kinder-und Jugendmedizin
  • Riesa, Germany, 01587
    • Hautarztpraxis
  • Solingen, Germany, 42697
    • Richter - Fachaerztin fuer Kinder- und Jugendmedizin
  • Stuttgart, Germany, 70499
    • Termeer, Christian
  • Tuebingen, Germany, 72076
    • Universitaets-Hautklinik Tuebingen
  • Wesel, Germany, 46483
    • Marienhospital Wesel Kinderklinik/Forschungsinstitut
  • Wesseling, Germany, 50389
    • Kinderarztpraxis
  • Wusterwitz, Germany, 14789
    • Hautarztpraxis
• Ireland
  • Cork, Ireland
    • South Infirmary
  • Dublin, Ireland, 12
    • Our Lady's Hospital For Sick Children
  • Dublin, Ireland, 18
    • The Park Clinic
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen
  • Nijmegen, Netherlands, 6525 GA
    • Universitair Medisch Centrum St. Radboud
• Poland
  • Bydgoszcz, Poland, 85-077
    • Prywatna Praktyka Lekarska "Alergomed"
  • Bydgoszcz, Poland, 85-667
    • Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego w Bydgoszczy, Wojewodzka Przychodnia Specjalistyczna Dla Dzieci Poradnia ermatologiczna, Budynek "A"
  • Bydgoszcz, Poland, 85-794
    • Private Practice
  • Gdańsk, Poland, 80-308
    • Szpital Dzieciecy Specjalistyczny Z.O.Z. nad Matka i Dzieckiem
  • Gostynin, Poland, 09-500
    • Praktyka Lekarska
  • Krakow, Poland, 31-913
    • SPZOZ Szpital Specjalistyczny im. S. Zeromskiego
  • Lodz, Poland, 90-436
    • Dermoklinika
  • Lodz, Poland, 90-553
    • NZOZ Centrum Alergologii
  • Lublin, Poland, 20-803
    • Alergovita
  • Sierpc, Poland, 09-200
    • Indywidualna Specjalistyczna Praktyka Lekarska
  • Torun, Poland, 87-100
    • NZOZ Przychodnia Dermatologiczna DERMED s.c
• United Kingdom
  • Amersham, United Kingdom, HP7 0JD
    • Amersham Hospital, Department of Dermatology
  • Birmingham, United Kingdom, B4 6NH
    • Birmingham Children's Hospital
  • Bolton, United Kingdom, BL4 0JR
    • Royal Bolton Hospitals Trust
  • Cambridge, United Kingdom, CB2 2QQ
    • Addenbrooke's Hospital
  • Cardiff, United Kingdom, CF14 4XN
    • Wales College of Medicine, Cardiff University, Heath Park
  • Dundee, United Kingdom, DD1 9SY
    • Ninewells Hospital and Medical School
  • Edinburgh, United Kingdom, EH3 9YW
    • Royal Infirmary of Edinburgh
  • Harrogate, United Kingdom, HG2 7SX
    • Harrogate & District Foundation NHS Trust Hospital
  • Leeds, United Kingdom, LS1 3EX
    • Leeds General Infirmary, Dept of Dermatology
  • Leeds, United Kingdom, LS7 4SA
    • Site UK3007
  • Liverpool, United Kingdom, L12 2AP
    • Alder Hey Children's Hospital
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital
  • Manchester, United Kingdom, M13 9WL
    • Department of Pediatric Allergy and Immunology
  • Middlesex, United Kingdom, EN2 8JL
    • Chase Farm Hospital
  • Nuneaton, United Kingdom, CV10 7DJ
    • George Eliot Hospital
  • Salford, United Kingdom, M6 8HD
    • University of Manchester, Dermatology-Pharmacology Unit Hope Hospital
• United States
  • Alabama
    • Alabaster, Alabama, United States, 35007
      • Shelby Dermatology
    • Anniston, Alabama, United States, 36207
      • Pediatric Care Center of NE Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center
    • 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
      • Skin Wellness Center of Alabama
    • Birmingham, Alabama, United States, 35213
      • Southview Dermatology
    • Huntsville, Alabama, United States, 35801
      • Ruth A Yates
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Alliance Dermatology
    • Phoenix, Arizona, United States, 85048
      • Derma
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
    • Rogers, Arkansas, United States, 72758
      • Hull Dermatology, P.A.
  • California
    • Camarillo, California, United States, 93010
      • Coastal Allergy Care
    • Fountain Valley, California, United States, 92708
      • Tien Nguyen
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Mountain View, California, United States, 94040
      • California Skin Institute
    • Roseville, California, United States, 95661
      • Capital Allergy & Respiratory Disease Center
    • San Diego, California, United States, 92123
      • Rady Children's Hospital San Diego
    • San Diego, California, United States, 92111
      • Allergy and Immunology Clinic
    • San Ramon, California, United States, 94583
      • California Dermatology Care
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Medical Center Dept of Dermatology
    • New Haven, Connecticut, United States, 06519
      • Yale University School Of Medicine
  • Delaware
    • Hockessin, Delaware, United States, 19707
      • Webster Dermatology, PA
    • Wilmington, Delaware, United States, 19810
      • Atlantic Skin & Cosmetic Surgery Group
  • Florida
    • Boca Raton, Florida, United States, 33428
      • Center For Dermatology
    • Boynton Beach, Florida, United States, 33437
      • Angelos Koutsonikolis, MD, PA
    • Boynton Beach, Florida, United States, 33437
      • Joshua Berlin P.A.
    • Fort Lauderdale, Florida, United States, 33308
      • Fort Lauderdale Dermatology & Cosmetic Skin Center
    • Jacksonville, Florida, United States, 32204
      • North Florida Dermatology Associates, P.A.
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine
    • North Miami, Florida, United States, 33181
      • Andrea Trowers, MD
    • North Miami Beach, Florida, United States, 33162
      • Tory Patrick Sullivan
    • North Palm Beach, Florida, United States, 33408
      • Allergy Associates of The Palm Beaches, PA
    • Orlando, Florida, United States, 32819
      • Orlando Dermatology
    • Palm Beach Gardens, Florida, United States, 33418
      • Donna Zeide
    • Plantation, Florida, United States, 33324
      • Waterman Dermatology
    • Tampa, Florida, United States, 33615
      • Olympian Clinical Research
    • Tampa, Florida, United States, 33626
      • Dr.Robert A. Norman
  • Georgia
    • Albany, Georgia, United States, 31707
      • Georgia Pollens Clinical Research Centers, Inc
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Covington, Georgia, United States, 30014
      • Dermatology Consultants PC
    • Macon, Georgia, United States, 31217
      • Dermatologic Surgery Specialist Inc.
    • Newnan, Georgia, United States, 30263
      • MedaPhase,Inc.
    • Savannah, Georgia, United States, 31406
      • Aeroallergy Research Labs of Savannah, Inc.
    • Stockbridge, Georgia, United States, 30281
      • Southern Crescent Dermatology
  • Hawaii
    • 'Aiea, Hawaii, United States, 96701
      • Paul S. Takiguchi- MD- Inc.
    • 'Aiea, Hawaii, United States, 96701
      • Wayne Fujita, M.D. - Private Practice
  • Idaho
    • Boise, Idaho, United States, 83704
      • Dermatology Clinic of Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Southeast Idaho Family Practice
  • Illinois
    • Belleville, Illinois, United States, 62226
      • DermAssociates LTD
    • Champaign, Illinois, United States, 61820
      • Christie Clinic
    • Chicago, Illinois, United States, 60614
      • Children's Memorial Hospital
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Shideler Clinical Research Center
    • Carmel, Indiana, United States, 46032
      • Dermatology, Inc.
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group, LLC
    • Indianapolis, Indiana, United States, 46240
      • Dermatology Associates, PC
    • New Albany, Indiana, United States, 47150
      • The Dermatology Center
    • Plainfield, Indiana, United States, 46168
      • Dermatology Center of Indiana P.C.
    • West Lafayette, Indiana, United States, 47906
      • Randall Dermatology
  • Iowa
    • Clinton, Iowa, United States, 52732
      • Clinton Urgent Care
  • Kansas
    • Overland Park, Kansas, United States, 66209
      • Midwest Dermatology
    • Overland Park, Kansas, United States, 66215
      • Kansas City Dermatology, PA
    • Topeka, Kansas, United States, 66614
      • Kansas Medical Clinic, PA
    • Wichita, Kansas, United States, 67206
      • Mid-Kansas Dermatology Clinic, PA
  • Kentucky
    • Corbin, Kentucky, United States, 40701
      • Melissa Knuckles
    • Nicholasville, Kentucky, United States, 40356
      • Michael W. Simon, M.D.
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • LA Dermatology Assoc LLC
    • New Orleans, Louisiana, United States, 70115
      • Kids First Prytania
    • Opelousas, Louisiana, United States, 70570
      • All Kids Pediatrics of Opelousas APMC
    • Shreveport, Louisiana, United States, 71105
      • Highland Clinic
    • Shreveport, Louisiana, United States, 71103
      • Holliway Pediatric Clinic
    • Shreveport, Louisiana, United States, 71107
      • Wee Care Pediatrics & Kidmed Clinic
    • Shreveport, Louisiana, United States, 71129
      • Healing Hands Family Medicine
    • Slidell, Louisiana, United States, 70458
      • Dimitri Dermatology
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University, Division of Pediatric Dermatolgy
    • Clarksburg, Maryland, United States, 20871
      • Clarksburg Pediatrics, LLC
    • Gaithersburg, Maryland, United States, 20878
      • Family Allergy & Asthma Care
    • Glenn Dale, Maryland, United States, 20769
      • Callender Skin and Laser Center
    • Silver Spring, Maryland, United States, 20902
      • DermAssociates, PC
    • Silver Spring, Maryland, United States, 20904
      • Beverly Johnson, MD
    • White Plains, Maryland, United States, 20695
      • Robert S. Berger
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
    • Marlborough, Massachusetts, United States, 01752
      • Adult & Pediatric Dermatology
    • Quincy, Massachusetts, United States, 02169
      • Kenneth M. Reed, MD
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Drs. Iacobelli & DiGregorio, PC
    • Detroit, Michigan, United States, 48202
      • Henry Ford Medical Center
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
    • Grand Blanc, Michigan, United States, 48439
      • Silverton Skin Institute
    • Sterling Heights, Michigan, United States, 48314
      • SVC Dermatology PC
    • Troy, Michigan, United States, 48084
      • Somerset Skin Centre
    • Warren, Michigan, United States, 48093
      • Grekin Skin Institute
    • Warren, Michigan, United States, 48093
      • Midwest Center for Dermatology and Cosmetic Surgery
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • Dermatology Center for Children and Young Adults
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Mississippi
    • Jackson, Mississippi, United States, 39206
      • Asthma & Allergy Center of North Jackson
    • Jackson, Mississippi, United States, 39216
      • Peace Children's Clinic
  • Missouri
    • Florissant, Missouri, United States, 63031
      • North County Dermatology
    • Saint Joseph, Missouri, United States, 64506
      • Kosse Pediatrics
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • South Lincoln Dermatology Clinic
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists PC
  • Nevada
    • Henderson, Nevada, United States, 89014
      • Bettencourt Skin Center
    • Reno, Nevada, United States, 89509
      • Aistheta
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Glen Ridge, New Jersey, United States, 07028
      • Cheryl D. Ackerman
    • Ridgewood, New Jersey, United States, 07450
      • CDLC
    • Verona, New Jersey, United States, 07044
      • The Dermatology Group, PC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico
    • Los Alamos, New Mexico, United States, 87544
      • Allergy & Asthma Associates of NNM
  • New York
    • Bayside, New York, United States, 11360
      • New York Dermatology, P.C.
    • Brooklyn, New York, United States, 11209
      • Robert S. Darr, MD, PC
    • Brooklyn, New York, United States, 11228
      • Morris Westfried, M.D.
    • Garden City, New York, United States, 11530
      • Garden City Dermatology, P.C.
    • Hollis, New York, United States, 11432
      • Hollis Medisys
    • Lindenhurst, New York, United States, 11757
      • Marvin S.Watsky
    • Monroe, New York, United States, 10950
      • Orange Dermatology Assoc, PC
    • New York, New York, United States, 10025
      • St. Luke's Roosevelt Hospital Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center., Dept. of Medicine
    • Rochester, New York, United States, 14609
      • Helendale Dermatology & Medical Spa, LLC
    • Smithtown, New York, United States, 11787
      • Marina I Peredo, MD
    • Stony Brook, New York, United States, 11790
      • Derm Research Center of New York, Inc.
    • Suffern, New York, United States, 10901
      • Joseph D. Sutton, MD
    • Valley Stream, New York, United States, 11581
      • Stanley A. Newfield
  • North Carolina
    • Advance, North Carolina, United States, 27006
      • Davie Dermatology
    • Burlington, North Carolina, United States, 27215
      • Alamance Skin Center
    • Fayetteville, North Carolina, United States, 28305
      • Pediatrx Clinic
    • Lumberton, North Carolina, United States, 28358
      • Southeastern Dermatology, PA
    • Rocky Mount, North Carolina, United States, 27801
      • FMC/OIC
    • Wilmington, North Carolina, United States, 28401
      • DermOne Dermatology Center, PA
    • Wilmington, North Carolina, United States, 28403
      • Carolina Dermatology & Skin Cancer Surgery
    • Wilmington, North Carolina, United States, 28403
      • Knox Clinic Pediatrics, PLLC
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Haber Dermatology and Cosmetic Surgery, Inc
    • Cincinnati, Ohio, United States, 45230
      • Dermatology Research Associates, Inc.
    • Cincinnati, Ohio, United States, 45219
      • University Dermatology Consultants, Inc.
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Warren, Ohio, United States, 44484
      • Warren Dermatology & Allergy
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University Health Sciences Center
    • Oklahoma City, Oklahoma, United States, 73139
      • Brian Lepley, D.O.
    • Oklahoma City, Oklahoma, United States, 73139
      • Family Health Center South
    • Tulsa, Oklahoma, United States, 74127
      • OSU-CHS Houston Center Physicians
  • Pennsylvania
    • Fort Washington, Pennsylvania, United States, 19034
      • Philadelphia Institute of Dermatology
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • North Wales, Pennsylvania, United States, 19454
      • East Penn Dermatology
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Co, Inc.
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Dermatology and Laser Center of Charleston
    • Cheraw, South Carolina, United States, 29520
      • Cheraw Pediatrics, P.A.
    • Columbia, South Carolina, United States, 29201
      • Dermatology Group LLC
    • Columbia, South Carolina, United States, 29203
      • McClerklin Skin and Laser Center
    • Greenville, South Carolina, United States, 29406
      • Allergic Disease & Asthma Center
    • North Charleston, South Carolina, United States, 29420
      • National Allergy and Asthma Research, LLC
    • Rock Hill, South Carolina, United States, 29732
      • Palmetto Skin & Laser Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • The Asthma Institute PLLC
    • Goodlettsville, Tennessee, United States, 37072
      • Rivergate Dermatology Research Center
    • Kingsport, Tennessee, United States, 37660
      • Dermatology Associates of Kingsport, PC
    • Knoxville, Tennessee, United States, 37917
      • Dermatology Associates of Knoxville, PC
    • Knoxville, Tennessee, United States, 37922
      • The Skin Wellness Center
    • Knoxville, Tennessee, United States, 37909
      • Allergy Associates, PA dba East Tennessee Center for Clinical Research
    • Memphis, Tennessee, United States, 38104
      • Sheffield Pediatrics, PLLC
    • Memphis, Tennessee, United States, 38128
      • Raleigh Group PC
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Center for Dermatology
    • Arlington, Texas, United States, 76002
      • Academy of Clinical Research
    • Austin, Texas, United States, 78759
      • Zoltan Trizna
    • Dallas, Texas, United States, 75230
      • Allergy Partners North Texas Research
    • Dallas, Texas, United States, 75230
      • Dermatology Treatment and Research Center, PA
    • El Paso, Texas, United States, 79903
      • Western Sky Medical Research
    • Fort Worth, Texas, United States, 76107
      • University of N. Texas Health Science Center
    • Fort Worth, Texas, United States, 76109
      • North Texas Institute for Clinical Trials
    • Frisco, Texas, United States, 75035
      • Dermatology Center of Frisco
    • Grapevine, Texas, United States, 76051
      • Pediatric Dermatology of North Texas PA
    • Harlingen, Texas, United States, 78550
      • Stephen Schwartz
    • Houston, Texas, United States, 77082
      • West Houston Dermatology, PA
    • Houston, Texas, United States, 77030
      • University of Texas - Houston
    • Houston, Texas, United States, 77008
      • Heights Dermatology & Aesthetic Center
    • Houston, Texas, United States, 77084
      • Bear Creek Clinic, PA
    • Houston, Texas, United States, 77092
      • Lone Star Children's Medical PLLC
    • Irving, Texas, United States, 75061
      • Dermatology and Laser Center
    • Irving, Texas, United States, 75061
      • Site US0048
    • Lubbock, Texas, United States, 79410
      • Lubbock Dermatology and Skin Cancer Center
    • McAllen, Texas, United States, 78504
      • Rick Lin, D.O., MPH
    • Pasadena, Texas, United States, 77506
      • Pasadena Dermatology Clinic
    • Spring, Texas, United States, 77373
      • Medical Research Network
    • Tyler, Texas, United States, 75703
      • Dermatology Research Associates of Tyler
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Dermatology Research Center
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Brookside Pediatrics
  • Virginia
    • Arlington, Virginia, United States, 22204
      • Glenn H. Fuchs, MD PC
    • Centreville, Virginia, United States, 20121
      • Dermatology Assoc of Northern Vineland
    • Martinsville, Virginia, United States, 24112
      • Piedmont Dermatology Center, PC
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc.
    • Norfolk, Virginia, United States, 23507
      • Children's Hospital of the Kings Daughters
  • Washington
    • Seattle, Washington, United States, 98115
      • ASTHMA, Inc.
    • Seattle, Washington, United States, 98101
      • Dermatology Associates, PLLC
    • Walla Walla, Washington, United States, 99362
      • Eastern Washington Dermatology
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Univeristy of Wisconsin-Madison
    • Milwaukee, Wisconsin, United States, 53208
      • George V. Chandy MD SC
  • Wyoming
    • Casper, Wyoming, United States, 82609
      • Central Wyoming Skin Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1. Protopic Exposure; Pediatric subjects whose ages are/were <16 years at the time of first tacrolimus ointment exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of systemic or cutaneous malignancy	Standardised Incidence Ratio (versus population cancer rates)	10 years

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: LEO Pharma A/S, Medical Expert

Publications and helpful links

General Publications

• D3T01.1J No increased risk of cancer in children using topical tacrolimus for atopic dermatitis: A 10-year prospective cohort study Prof. Dr. Regina Fölster-Holst - Germany 12 October 2019 11:00 - 11:15 EADV 2019

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2005
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: May 17, 2007
• First Submitted That Met QC Criteria: May 17, 2007
• First Posted (Estimate): May 21, 2007

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 16, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: atopic dermatitis; child; tacrolimus ointment; Protopic Ointment
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: F506-CL-5801; FG506-06-37 (Other Identifier: Sponsor); 03-0-161 (Other Identifier: Sponsor (Astellas)); EUPAS (Registry Identifier: EUPAS12360); LP0156-1294 (Other Identifier: Sponsor (LEO Pharma A/S))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No