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En pædiatrisk longitudinel evaluering for at vurdere den langsigtede sikkerhed af Protopic til behandling af atopisk dermatitis (APPLES)

16. december 2019 opdateret af: LEO Pharma

APPLES: En prospektiv pædiatrisk longitudinel evaluering for at vurdere den langsigtede sikkerhed af tacrolimus salve til behandling af atopisk dermatitis

Dette er et observationsstudie for at vurdere den langsigtede sikkerhed af Protopic® Ointment til behandling af atopisk dermatitis. Patienter, hvis alder er/var < 16 år på tidspunktet for første eksponering for tacrolimussalve, er berettiget til at deltage. Intet lægemiddel distribueres under dette observationsforsøg.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Data vil blive indsamlet ved tilmelding og hver 6. måned derefter enten ved interview, internet eller lægebesøg. Hvert emne vil blive fulgt i 10 år i denne undersøgelse.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

8071

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Det Forenede Kongerige
      • Amersham, Det Forenede Kongerige, HP7 0JD
        • Amersham Hospital, Department of Dermatology
      • Birmingham, Det Forenede Kongerige, B4 6NH
        • Birmingham Children's Hospital
      • Bolton, Det Forenede Kongerige, BL4 0JR
        • Royal Bolton Hospitals Trust
      • Cambridge, Det Forenede Kongerige, CB2 2QQ
        • Addenbrooke's Hospital
      • Cardiff, Det Forenede Kongerige, CF14 4XN
        • Wales College of Medicine, Cardiff University, Heath Park
      • Dundee, Det Forenede Kongerige, DD1 9SY
        • Ninewells Hospital and Medical School
      • Edinburgh, Det Forenede Kongerige, EH3 9YW
        • Royal Infirmary of Edinburgh
      • Harrogate, Det Forenede Kongerige, HG2 7SX
        • Harrogate & District Foundation NHS Trust Hospital
      • Leeds, Det Forenede Kongerige, LS1 3EX
        • Leeds General Infirmary, Dept of Dermatology
      • Leeds, Det Forenede Kongerige, LS7 4SA
        • Site UK3007
      • Liverpool, Det Forenede Kongerige, L12 2AP
        • Alder Hey Children's Hospital
      • London, Det Forenede Kongerige, NW3 2QG
        • Royal Free Hospital
      • Manchester, Det Forenede Kongerige, M13 9WL
        • Department of Pediatric Allergy and Immunology
      • Middlesex, Det Forenede Kongerige, EN2 8JL
        • Chase Farm Hospital
      • Nuneaton, Det Forenede Kongerige, CV10 7DJ
        • George Eliot Hospital
      • Salford, Det Forenede Kongerige, M6 8HD
        • University of Manchester, Dermatology-Pharmacology Unit Hope Hospital
  • Forenede Stater
    • Alabama
      • Alabaster, Alabama, Forenede Stater, 35007
        • Shelby Dermatology
      • Anniston, Alabama, Forenede Stater, 36207
        • Pediatric Care Center of NE Alabama
      • Birmingham, Alabama, Forenede Stater, 35205
        • Total Skin And Beauty Dermatology Center
      • Birmingham, Alabama, Forenede Stater, 35209
        • Metro Pediatrics, P.C
      • Birmingham, Alabama, Forenede Stater, 35209
        • Pediatric & Adult Asthma and Allergy, P.C.
      • Birmingham, Alabama, Forenede Stater, 35209
        • Skin Wellness Center of Alabama
      • Birmingham, Alabama, Forenede Stater, 35213
        • Southview Dermatology
      • Huntsville, Alabama, Forenede Stater, 35801
        • Ruth A Yates
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85032
        • Alliance Dermatology
      • Phoenix, Arizona, Forenede Stater, 85048
        • Derma
    • Arkansas
      • Hot Springs, Arkansas, Forenede Stater, 71913
        • Burke Pharmaceutical Research
      • Little Rock, Arkansas, Forenede Stater, 72205
        • University of Arkansas for Medical Sciences
      • Rogers, Arkansas, Forenede Stater, 72758
        • Hull Dermatology, P.A.
    • California
      • Camarillo, California, Forenede Stater, 93010
        • Coastal Allergy Care
      • Fountain Valley, California, Forenede Stater, 92708
        • Tien Nguyen
      • Los Angeles, California, Forenede Stater, 90045
        • Dermatology Research Associates
      • Mountain View, California, Forenede Stater, 94040
        • California Skin Institute
      • Roseville, California, Forenede Stater, 95661
        • Capital Allergy & Respiratory Disease Center
      • San Diego, California, Forenede Stater, 92123
        • Rady Children's Hospital San Diego
      • San Diego, California, Forenede Stater, 92111
        • Allergy and Immunology Clinic
      • San Ramon, California, Forenede Stater, 94583
        • California Dermatology Care
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06106
        • Connecticut Children's Medical Center Dept of Dermatology
      • New Haven, Connecticut, Forenede Stater, 06519
        • Yale University School of Medicine
    • Delaware
      • Hockessin, Delaware, Forenede Stater, 19707
        • Webster Dermatology, PA
      • Wilmington, Delaware, Forenede Stater, 19810
        • Atlantic Skin & Cosmetic Surgery Group
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33428
        • Center for Dermatology
      • Boynton Beach, Florida, Forenede Stater, 33437
        • Angelos Koutsonikolis, MD, PA
      • Boynton Beach, Florida, Forenede Stater, 33437
        • Joshua Berlin P.A.
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • Fort Lauderdale Dermatology & Cosmetic Skin Center
      • Jacksonville, Florida, Forenede Stater, 32204
        • North Florida Dermatology Associates, P.A.
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Miller School of Medicine
      • North Miami, Florida, Forenede Stater, 33181
        • Andrea Trowers, MD
      • North Miami Beach, Florida, Forenede Stater, 33162
        • Tory Patrick Sullivan
      • North Palm Beach, Florida, Forenede Stater, 33408
        • Allergy Associates of The Palm Beaches, PA
      • Orlando, Florida, Forenede Stater, 32819
        • Orlando Dermatology
      • Palm Beach Gardens, Florida, Forenede Stater, 33418
        • Donna Zeide
      • Plantation, Florida, Forenede Stater, 33324
        • Waterman Dermatology
      • Tampa, Florida, Forenede Stater, 33615
        • Olympian Clinical Research
      • Tampa, Florida, Forenede Stater, 33626
        • Dr.Robert A. Norman
    • Georgia
      • Albany, Georgia, Forenede Stater, 31707
        • Georgia Pollens Clinical Research Centers, Inc
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University
      • Covington, Georgia, Forenede Stater, 30014
        • Dermatology Consultants PC
      • Macon, Georgia, Forenede Stater, 31217
        • Dermatologic Surgery Specialist Inc.
      • Newnan, Georgia, Forenede Stater, 30263
        • MedaPhase,Inc.
      • Savannah, Georgia, Forenede Stater, 31406
        • Aeroallergy Research Labs of Savannah, Inc.
      • Stockbridge, Georgia, Forenede Stater, 30281
        • Southern Crescent Dermatology
    • Hawaii
      • 'Aiea, Hawaii, Forenede Stater, 96701
        • Paul S. Takiguchi- MD- Inc.
      • 'Aiea, Hawaii, Forenede Stater, 96701
        • Wayne Fujita, M.D. - Private Practice
    • Idaho
      • Boise, Idaho, Forenede Stater, 83704
        • Dermatology Clinic of Idaho
      • Idaho Falls, Idaho, Forenede Stater, 83404
        • Southeast Idaho Family Practice
    • Illinois
      • Belleville, Illinois, Forenede Stater, 62226
        • DermAssociates LTD
      • Champaign, Illinois, Forenede Stater, 61820
        • Christie Clinic
      • Chicago, Illinois, Forenede Stater, 60614
        • Children's Memorial Hospital
    • Indiana
      • Carmel, Indiana, Forenede Stater, 46032
        • Shideler Clinical Research Center
      • Carmel, Indiana, Forenede Stater, 46032
        • Dermatology, Inc.
      • Indianapolis, Indiana, Forenede Stater, 46256
        • Dawes Fretzin Clinical Research Group, LLC
      • Indianapolis, Indiana, Forenede Stater, 46240
        • Dermatology Associates, PC
      • New Albany, Indiana, Forenede Stater, 47150
        • The Dermatology Center
      • Plainfield, Indiana, Forenede Stater, 46168
        • Dermatology Center of Indiana P.C.
      • West Lafayette, Indiana, Forenede Stater, 47906
        • Randall Dermatology
    • Iowa
      • Clinton, Iowa, Forenede Stater, 52732
        • Clinton Urgent Care
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66209
        • Midwest Dermatology
      • Overland Park, Kansas, Forenede Stater, 66215
        • Kansas City Dermatology, PA
      • Topeka, Kansas, Forenede Stater, 66614
        • Kansas Medical Clinic, PA
      • Wichita, Kansas, Forenede Stater, 67206
        • Mid-Kansas Dermatology Clinic, PA
    • Kentucky
      • Corbin, Kentucky, Forenede Stater, 40701
        • Melissa Knuckles
      • Nicholasville, Kentucky, Forenede Stater, 40356
        • Michael W. Simon, M.D.
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • LA Dermatology Assoc LLC
      • New Orleans, Louisiana, Forenede Stater, 70115
        • Kids First Prytania
      • Opelousas, Louisiana, Forenede Stater, 70570
        • All Kids Pediatrics of Opelousas APMC
      • Shreveport, Louisiana, Forenede Stater, 71105
        • Highland Clinic
      • Shreveport, Louisiana, Forenede Stater, 71103
        • Holliway Pediatric Clinic
      • Shreveport, Louisiana, Forenede Stater, 71107
        • Wee Care Pediatrics & Kidmed Clinic
      • Shreveport, Louisiana, Forenede Stater, 71129
        • Healing Hands Family Medicine
      • Slidell, Louisiana, Forenede Stater, 70458
        • Dimitri Dermatology
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins University, Division of Pediatric Dermatolgy
      • Clarksburg, Maryland, Forenede Stater, 20871
        • Clarksburg Pediatrics, LLC
      • Gaithersburg, Maryland, Forenede Stater, 20878
        • Family Allergy & Asthma Care
      • Glenn Dale, Maryland, Forenede Stater, 20769
        • Callender Skin and Laser Center
      • Silver Spring, Maryland, Forenede Stater, 20902
        • DermAssociates, PC
      • Silver Spring, Maryland, Forenede Stater, 20904
        • Beverly Johnson, MD
      • White Plains, Maryland, Forenede Stater, 20695
        • Robert S. Berger
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Boston Children's Hospital
      • Marlborough, Massachusetts, Forenede Stater, 01752
        • Adult & Pediatric Dermatology
      • Quincy, Massachusetts, Forenede Stater, 02169
        • Kenneth M. Reed, MD
    • Michigan
      • Clinton Township, Michigan, Forenede Stater, 48038
        • Drs. Iacobelli & DiGregorio, PC
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Medical Center
      • Fort Gratiot, Michigan, Forenede Stater, 48059
        • Hamzavi Dermatology
      • Grand Blanc, Michigan, Forenede Stater, 48439
        • Silverton Skin Institute
      • Sterling Heights, Michigan, Forenede Stater, 48314
        • SVC Dermatology PC
      • Troy, Michigan, Forenede Stater, 48084
        • Somerset Skin Centre
      • Warren, Michigan, Forenede Stater, 48093
        • Grekin Skin Institute
      • Warren, Michigan, Forenede Stater, 48093
        • Midwest Center for Dermatology and Cosmetic Surgery
    • Minnesota
      • Eagan, Minnesota, Forenede Stater, 55121
        • Dermatology Center for Children and Young Adults
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39206
        • Asthma & Allergy Center of North Jackson
      • Jackson, Mississippi, Forenede Stater, 39216
        • Peace Children's Clinic
    • Missouri
      • Florissant, Missouri, Forenede Stater, 63031
        • North County Dermatology
      • Saint Joseph, Missouri, Forenede Stater, 64506
        • Kosse Pediatrics
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68502
        • South Lincoln Dermatology Clinic
      • Omaha, Nebraska, Forenede Stater, 68144
        • Skin Specialists PC
    • Nevada
      • Henderson, Nevada, Forenede Stater, 89014
        • Bettencourt Skin Center
      • Reno, Nevada, Forenede Stater, 89509
        • Aistheta
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Glen Ridge, New Jersey, Forenede Stater, 07028
        • Cheryl D. Ackerman
      • Ridgewood, New Jersey, Forenede Stater, 07450
        • CDLC
      • Verona, New Jersey, Forenede Stater, 07044
        • The Dermatology Group, PC
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131
        • University of New Mexico
      • Los Alamos, New Mexico, Forenede Stater, 87544
        • Allergy & Asthma Associates of NNM
    • New York
      • Bayside, New York, Forenede Stater, 11360
        • New York Dermatology, P.C.
      • Brooklyn, New York, Forenede Stater, 11209
        • Robert S. Darr, MD, PC
      • Brooklyn, New York, Forenede Stater, 11228
        • Morris Westfried, M.D.
      • Garden City, New York, Forenede Stater, 11530
        • Garden City Dermatology, P.C.
      • Hollis, New York, Forenede Stater, 11432
        • Hollis Medisys
      • Lindenhurst, New York, Forenede Stater, 11757
        • Marvin S.Watsky
      • Monroe, New York, Forenede Stater, 10950
        • Orange Dermatology Assoc, PC
      • New York, New York, Forenede Stater, 10025
        • St. Luke's Roosevelt Hospital Center
      • New York, New York, Forenede Stater, 10032
        • Columbia University Medical Center., Dept. of Medicine
      • Rochester, New York, Forenede Stater, 14609
        • Helendale Dermatology & Medical Spa, LLC
      • Smithtown, New York, Forenede Stater, 11787
        • Marina I Peredo, MD
      • Stony Brook, New York, Forenede Stater, 11790
        • Derm Research Center of New York, Inc.
      • Suffern, New York, Forenede Stater, 10901
        • Joseph D. Sutton, MD
      • Valley Stream, New York, Forenede Stater, 11581
        • Stanley A. Newfield
    • North Carolina
      • Advance, North Carolina, Forenede Stater, 27006
        • Davie Dermatology
      • Burlington, North Carolina, Forenede Stater, 27215
        • Alamance Skin Center
      • Fayetteville, North Carolina, Forenede Stater, 28305
        • Pediatrx Clinic
      • Lumberton, North Carolina, Forenede Stater, 28358
        • Southeastern Dermatology, PA
      • Rocky Mount, North Carolina, Forenede Stater, 27801
        • FMC/OIC
      • Wilmington, North Carolina, Forenede Stater, 28401
        • DermOne Dermatology Center, PA
      • Wilmington, North Carolina, Forenede Stater, 28403
        • Carolina Dermatology & Skin Cancer Surgery
      • Wilmington, North Carolina, Forenede Stater, 28403
        • Knox Clinic Pediatrics, PLLC
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University School of Medicine
    • Ohio
      • Beachwood, Ohio, Forenede Stater, 44122
        • Haber Dermatology and Cosmetic Surgery, Inc
      • Cincinnati, Ohio, Forenede Stater, 45230
        • Dermatology Research Associates, Inc.
      • Cincinnati, Ohio, Forenede Stater, 45219
        • University Dermatology Consultants, Inc.
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation
      • Warren, Ohio, Forenede Stater, 44484
        • Warren Dermatology & Allergy
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Oklahoma University Health Sciences Center
      • Oklahoma City, Oklahoma, Forenede Stater, 73139
        • Brian Lepley, D.O.
      • Oklahoma City, Oklahoma, Forenede Stater, 73139
        • Family Health Center South
      • Tulsa, Oklahoma, Forenede Stater, 74127
        • OSU-CHS Houston Center Physicians
    • Pennsylvania
      • Fort Washington, Pennsylvania, Forenede Stater, 19034
        • Philadelphia Institute of Dermatology
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Penn State Milton S. Hershey Medical Center
      • North Wales, Pennsylvania, Forenede Stater, 19454
        • East Penn Dermatology
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 19103
        • Paddington Testing Co, Inc.
    • Rhode Island
      • Johnston, Rhode Island, Forenede Stater, 02919
        • Clinical Partners, LLC
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29414
        • Dermatology and Laser Center of Charleston
      • Cheraw, South Carolina, Forenede Stater, 29520
        • Cheraw Pediatrics, P.A.
      • Columbia, South Carolina, Forenede Stater, 29201
        • Dermatology Group LLC
      • Columbia, South Carolina, Forenede Stater, 29203
        • McClerklin Skin and Laser Center
      • Greenville, South Carolina, Forenede Stater, 29406
        • Allergic Disease & Asthma Center
      • North Charleston, South Carolina, Forenede Stater, 29420
        • National Allergy and Asthma Research, LLC
      • Rock Hill, South Carolina, Forenede Stater, 29732
        • Palmetto Skin & Laser Center
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37421
        • The Asthma Institute PLLC
      • Goodlettsville, Tennessee, Forenede Stater, 37072
        • Rivergate Dermatology Research Center
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Dermatology Associates of Kingsport, PC
      • Knoxville, Tennessee, Forenede Stater, 37917
        • Dermatology Associates of Knoxville, PC
      • Knoxville, Tennessee, Forenede Stater, 37922
        • The Skin Wellness Center
      • Knoxville, Tennessee, Forenede Stater, 37909
        • Allergy Associates, PA dba East Tennessee Center for Clinical Research
      • Memphis, Tennessee, Forenede Stater, 38104
        • Sheffield Pediatrics, PLLC
      • Memphis, Tennessee, Forenede Stater, 38128
        • Raleigh Group PC
    • Texas
      • Arlington, Texas, Forenede Stater, 76011
        • Arlington Center for Dermatology
      • Arlington, Texas, Forenede Stater, 76002
        • Academy of Clinical Research
      • Austin, Texas, Forenede Stater, 78759
        • Zoltan Trizna
      • Dallas, Texas, Forenede Stater, 75230
        • Allergy Partners North Texas Research
      • Dallas, Texas, Forenede Stater, 75230
        • Dermatology Treatment and Research Center, PA
      • El Paso, Texas, Forenede Stater, 79903
        • Western Sky Medical Research
      • Fort Worth, Texas, Forenede Stater, 76107
        • University of N. Texas Health Science Center
      • Fort Worth, Texas, Forenede Stater, 76109
        • North Texas Institute for Clinical Trials
      • Frisco, Texas, Forenede Stater, 75035
        • Dermatology Center of Frisco
      • Grapevine, Texas, Forenede Stater, 76051
        • Pediatric Dermatology of North Texas PA
      • Harlingen, Texas, Forenede Stater, 78550
        • Stephen Schwartz
      • Houston, Texas, Forenede Stater, 77082
        • West Houston Dermatology, PA
      • Houston, Texas, Forenede Stater, 77030
        • University of Texas - Houston
      • Houston, Texas, Forenede Stater, 77008
        • Heights Dermatology & Aesthetic Center
      • Houston, Texas, Forenede Stater, 77084
        • Bear Creek Clinic, PA
      • Houston, Texas, Forenede Stater, 77092
        • Lone Star Children's Medical PLLC
      • Irving, Texas, Forenede Stater, 75061
        • Dermatology and Laser Center
      • Irving, Texas, Forenede Stater, 75061
        • Site US0048
      • Lubbock, Texas, Forenede Stater, 79410
        • Lubbock Dermatology and Skin Cancer Center
      • McAllen, Texas, Forenede Stater, 78504
        • Rick Lin, D.O., MPH
      • Pasadena, Texas, Forenede Stater, 77506
        • Pasadena Dermatology Clinic
      • Spring, Texas, Forenede Stater, 77373
        • Medical Research Network
      • Tyler, Texas, Forenede Stater, 75703
        • Dermatology Research Associates of Tyler
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84117
        • Dermatology Research Center
    • Vermont
      • Bennington, Vermont, Forenede Stater, 05201
        • Brookside Pediatrics
    • Virginia
      • Arlington, Virginia, Forenede Stater, 22204
        • Glenn H. Fuchs, MD PC
      • Centreville, Virginia, Forenede Stater, 20121
        • Dermatology Assoc of Northern Vineland
      • Martinsville, Virginia, Forenede Stater, 24112
        • Piedmont Dermatology Center, PC
      • Norfolk, Virginia, Forenede Stater, 23507
        • Virginia Clinical Research, Inc.
      • Norfolk, Virginia, Forenede Stater, 23507
        • Children's Hospital of the Kings Daughters
    • Washington
      • Seattle, Washington, Forenede Stater, 98115
        • ASTHMA, Inc.
      • Seattle, Washington, Forenede Stater, 98101
        • Dermatology Associates, PLLC
      • Walla Walla, Washington, Forenede Stater, 99362
        • Eastern Washington Dermatology
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • Univeristy of Wisconsin-Madison
      • Milwaukee, Wisconsin, Forenede Stater, 53208
        • George V. Chandy MD SC
    • Wyoming
      • Casper, Wyoming, Forenede Stater, 82609
        • Central Wyoming Skin Clinic
  • Frankrig
      • Amiens, Frankrig, 80090
        • Cabinet Medical
      • Bordeaux, Frankrig, 33000
        • Hopital Pellegrin
      • Boulogne, Frankrig, 62200
        • Cabinet de Dermatologie - Boulogne-Sur-Mer
      • Boulogne, Frankrig, 92100
        • Cabinet de Dermatologie - Boulogne
      • Brest Cedex 2, Frankrig, 29609
        • Hopital Augustin Morvan
      • Cannes, Frankrig, 06400
        • Cabinet de dermatologie - Cannes
      • Chambray Les Tours Cedex, Frankrig, 37171
        • Hôpital Trousseau
      • Le Mans Cedex, Frankrig, 72037
        • Centre hospitalier
      • Lille Cedex, Frankrig, 59037
        • Hopital Claude Huriez
      • Martigues, Frankrig, 13500
        • Cabinet de Dermatologie - Martigues
      • Nantes, Frankrig, 44100
        • Cabinet Dermatologie
      • Nantes Cedex 1, Frankrig, 44093
        • Hôpital de l'Hôtel Dieu
      • Nice, Frankrig, 06000
        • Cabinet de dermatologie
      • Paris, Frankrig, 75007
        • Cabinet de Dermatologie - Paris
      • Paris Cedex 10, Frankrig, 75475
        • Hospital Saint Louis
      • Paris Cedex 15, Frankrig, 75743
        • Hospital Necker
      • Poitiers Cedex, Frankrig, 86021
        • CHU La MILETRIE Service de Dermatologie
      • Rouen Cedex, Frankrig, 76031
        • HOPITAL CHARLES NICOLLE Service de Dermatologie
      • St. Priest En Jarez Cedex, Frankrig, 42277
        • Hôpital Nord
      • Strasbourg, Frankrig, 67000
        • Cabinet de Dermatologie-Strasbourg
      • Thann, Frankrig, 68800
        • Cabinet de dermatologie
      • Toulouse Cedex 9, Frankrig, 31059
        • Hôpital Larrey
      • Troyes Cedex, Frankrig, 10003
        • Centre Hospitalier Service de Dermatologie
      • Équeurdreville-Hainneville, Frankrig, 50120
        • Polyclinique Du Cotentin
  • Holland
      • Amsterdam, Holland, 1105 AZ
        • Academisch Medisch Centrum
      • Groningen, Holland, 9713 GZ
        • Universitair Medisch Centrum Groningen
      • Nijmegen, Holland, 6525 GA
        • Universitair Medisch Centrum St. Radboud
  • Irland
      • Cork, Irland
        • South Infirmary
      • Dublin, Irland, 12
        • Our Lady's Hospital for Sick Children
      • Dublin, Irland, 18
        • The Park Clinic
  • Polen
      • Bydgoszcz, Polen, 85-077
        • Prywatna Praktyka Lekarska "Alergomed"
      • Bydgoszcz, Polen, 85-667
        • Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego w Bydgoszczy, Wojewodzka Przychodnia Specjalistyczna Dla Dzieci Poradnia ermatologiczna, Budynek "A"
      • Bydgoszcz, Polen, 85-794
        • Private Practice
      • Gdańsk, Polen, 80-308
        • Szpital Dzieciecy Specjalistyczny Z.O.Z. nad Matka i Dzieckiem
      • Gostynin, Polen, 09-500
        • Praktyka Lekarska
      • Krakow, Polen, 31-913
        • SPZOZ Szpital Specjalistyczny im. S. Zeromskiego
      • Lodz, Polen, 90-436
        • Dermoklinika
      • Lodz, Polen, 90-553
        • Nzoz Centrum Alergologii
      • Lublin, Polen, 20-803
        • Alergovita
      • Sierpc, Polen, 09-200
        • Indywidualna Specjalistyczna Praktyka Lekarska
      • Torun, Polen, 87-100
        • NZOZ Przychodnia Dermatologiczna DERMED s.c
  • Tyskland
      • Augsburg, Tyskland, 86179
        • Licca Fachklinik f. aesthetisch- operative Dermatologie und Chirurgie
      • Bamberg, Tyskland, 96050
        • Kinderarztpraxis
      • Berlin, Tyskland, 10117
        • Charite - Universitaetsmedizin Berlin Klinik fuer Dermatologie, Venerologie u. Allergologie
      • Berlin, Tyskland, 13055
        • Hautarztpraxis
      • Berlin, Tyskland, 13597
        • Hautarztpraxis
      • Bochum, Tyskland, 44791
        • Klinik fuer Kinder u. Jugendmedizin der Ruhr Universitaet Bochum im St.-Josef-Hospital
      • Bonn, Tyskland, 53105
        • Universitaet Bonn Klinik und Poliklinik fuer Dermatologie
      • Bremen, Tyskland, 28239
        • Hautarztpraxis
      • Bremen, Tyskland, 28779
        • Hautarztpraxis
      • Buxtehude, Tyskland, 21614
        • Dermatologisches Zentrum Buxtehude
      • Crimmitschau, Tyskland, 08451
        • Hautarztpraxis
      • Dessau, Tyskland, 06842
        • Hautarztpraxis
      • Dresden, Tyskland, 01097
        • Hautarztpraxis
      • Dresden, Tyskland, 01169
        • Arztpraxis fuer Hautkrankheiten
      • Dresden, Tyskland, 01307
        • Klinik und Poliklinik f. Dermatologie Universitaetsklinikum Dresden
      • Duesseldorf, Tyskland, 40225
        • Hautklinik
      • Duesseldorf, Tyskland, 40225
        • Heinrich-Heine-Universitaet Hautklinik
      • Erlangen, Tyskland, 91054
        • Hautklinik des Universitaetsklinikums Erlangen
      • Frankenberg, Tyskland, 35066
        • Falker, Gernot, Hautarztpraxis
      • Frankfurt, Tyskland, 60590
        • Universitaetsklinikum Klinische Forschung, Zentrum d. Dermatologie u. Venerologie
      • Friedrichshafen, Tyskland, 88045
        • Derma-Study-Center-Friedrichshafen
      • Gelnhausen, Tyskland, 63571
        • Hautarztpraxis
      • Gera, Tyskland, 07548
        • SRH Wald-Klinikum Gera GmbH
      • Hamburg, Tyskland, 22149
        • Kath. Kinderkrankenhaus Wilhelmstift
      • Hannover, Tyskland, 30159
        • Klinische Forschung Hannover-Mitte GmbH
      • Herborn, Tyskland, 35745
        • Brinkmann, Hautarztpraxis
      • Itzehoe, Tyskland, 25524
        • Hautarztpraxis Sempell
      • Jena, Tyskland, 07743
        • Klinikum der Fr.-Schiller-Universitaet
      • Kiel, Tyskland, 24105
        • Universitaet Hautklinik Kiel
      • Kiel, Tyskland, 24148
        • DermaKiel-Hautarztpraxis
      • Leipzig, Tyskland, 04103
        • Klinik fuer Dermatologie, Venerologie u. Allergologie
      • Mainz, Tyskland, 55131
        • Johannes-Gutenberg Universitaet
      • Marburg, Tyskland, 35034
        • Universitaetsklinikum Giessen+ Marburg Dermatolgie und Allergologie
      • Marburg, Tyskland, 35037
        • Praxis Dermatologie
      • Markkleeberg, Tyskland, 04416
        • Hautarztpraxis
      • Moenchengladbach, Tyskland, 41066
        • Kinder- und Jugendaertzin
      • Muenchen, Tyskland, 80337
        • Ludwig - Maximilians Universitaet, Klinik u. Poliklinik fuer Dermatologie u. Allergologie
      • Muenster, Tyskland, 48149
        • Universitaetsklinikum Muenster, Klinik & Poliklinik Fuer Hautkrankheiten
      • Muenster, Tyskland, 48155
        • Proinnovera GmbH
      • Muenster, Tyskland, 48163
        • Facharzt f. Kinder-und Jugendmedizin
      • Ravensburg, Tyskland, 88212
        • Facharzt fuer Kinder-und Jugendmedizin
      • Riesa, Tyskland, 01587
        • Hautarztpraxis
      • Solingen, Tyskland, 42697
        • Richter - Fachaerztin fuer Kinder- und Jugendmedizin
      • Stuttgart, Tyskland, 70499
        • Termeer, Christian
      • Tuebingen, Tyskland, 72076
        • Universitaets-Hautklinik Tuebingen
      • Wesel, Tyskland, 46483
        • Marienhospital Wesel Kinderklinik/Forschungsinstitut
      • Wesseling, Tyskland, 50389
        • Kinderarztpraxis
      • Wusterwitz, Tyskland, 14789
        • Hautarztpraxis
  • Østrig
      • Feldkirch, Østrig, 6807
        • LKH Feldkirch
      • Linz, Østrig, 4020
        • Landesfrauen- und -kinderklinik
      • Salzburg, Østrig, 5020
        • Salzburger Landeskliniken

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 16 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Pædiatriske forsøgspersoner, hvis alder er/var <16 år på tidspunktet for første eksponering for tacrolimussalve

Beskrivelse

Inklusionskriterier:

  • Forsøgspersoner, der først brugte Protopic® 0,03 % eller 0,1 %, før de var 16 år og blev behandlet i mindst 6 uger til behandling af atopisk dermatitis, kan deltage i undersøgelsen.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
1. Protopisk eksponering
Pædiatriske forsøgspersoner, hvis alder er/var <16 år på tidspunktet for første eksponering for tacrolimussalve

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forekomst af systemisk eller kutan malignitet
Tidsramme: 10 år
Standardiseret incidensforhold (versus kræftrater i befolkningen)
10 år

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

LEO Pharma

Efterforskere

  • Studieleder: LEO Pharma A/S, Medical Expert

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • 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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. maj 2005

Primær færdiggørelse (Faktiske)

31. januar 2019

Studieafslutning (Faktiske)

31. januar 2019

Datoer for studieregistrering

Først indsendt

17. maj 2007

Først indsendt, der opfyldte QC-kriterier

17. maj 2007

Først opslået (Skøn)

21. maj 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. december 2019

Sidst verificeret

1. december 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • F506-CL-5801
  • FG506-06-37 (Anden identifikator: Sponsor)
  • 03-0-161 (Anden identifikator: Sponsor (Astellas))
  • EUPAS (Registry Identifier: EUPAS12360)
  • LP0156-1294 (Anden identifikator: Sponsor (LEO Pharma A/S))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Atopisk dermatitis

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Angola

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner