AzTrials
AzTrials

Atopic DermatitisAPPLESNCT00475605

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

An observational study of Atopic Dermatitis, run by LEO Pharma at 313 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages Up to 16 years
Conditions the study is for
Atopic Dermatitis
How many people
8,071 participants
Where
313 sitesin 9 countries
Study dates
25 May 2005to 31 Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 16 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

313 sites in 9 countries.

313 sites in 9 countries

United States198 sites
  • Paul S. Takiguchi- MD- Inc.

    ‘Aiea, Hawaii, 96701

  • Wayne Fujita, M.D. - Private Practice

    ‘Aiea, Hawaii, 96701

  • Davie Dermatology

    Advance, North Carolina, 27006

  • Shelby Dermatology

    Alabaster, Alabama, 35007

  • Georgia Pollens Clinical Research Centers, Inc

    Albany, Georgia, 31707

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • Pediatric Care Center of NE Alabama

    Anniston, Alabama, 36207

  • Academy of Clinical Research

    Arlington, Texas, 76002

  • Arlington Center for Dermatology

    Arlington, Texas, 76011

  • Glenn H. Fuchs, MD PC

    Arlington, Virginia, 22204

  • Emory University

    Atlanta, Georgia, 30322

  • Zoltan Trizna

    Austin, Texas, 78759

  • Johns Hopkins University, Division of Pediatric Dermatolgy

    Baltimore, Maryland, 21287

  • LA Dermatology Assoc LLC

    Baton Rouge, Louisiana, 70809

  • New York Dermatology, P.C.

    Bayside, New York, 11360

  • Haber Dermatology and Cosmetic Surgery, Inc

    Beachwood, Ohio, 44122

  • DermAssociates LTD

    Belleville, Illinois, 62226

  • Brookside Pediatrics

    Bennington, Vermont, 05201

  • Total Skin and Beauty Dermatology Center

    Birmingham, Alabama, 35205

  • Metro Pediatrics, P.C

    Birmingham, Alabama, 35209

  • Pediatric & Adult Asthma and Allergy, P.C.

    Birmingham, Alabama, 35209

  • Skin Wellness Center of Alabama

    Birmingham, Alabama, 35209

  • Southview Dermatology

    Birmingham, Alabama, 35213

  • Center for Dermatology

    Boca Raton, Florida, 33428

  • Dermatology Clinic of Idaho

    Boise, Idaho, 83704

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • Angelos Koutsonikolis, MD, PA

    Boynton Beach, Florida, 33437

  • Joshua Berlin P.A.

    Boynton Beach, Florida, 33437

  • Robert S. Darr, MD, PC

    Brooklyn, New York, 11209

  • Morris Westfried, M.D.

    Brooklyn, New York, 11228

  • Alamance Skin Center

    Burlington, North Carolina, 27215

  • Coastal Allergy Care

    Camarillo, California, 93010

  • Dermatology, Inc.

    Carmel, Indiana, 46032

  • Shideler Clinical Research Center

    Carmel, Indiana, 46032

  • Central Wyoming Skin Clinic

    Casper, Wyoming, 82609

  • Dermatology Assoc of Northern Vineland

    Centreville, Virginia, 20121

  • Christie Clinic

    Champaign, Illinois, 61820

  • Dermatology and Laser Center of Charleston

    Charleston, South Carolina, 29414

  • The Asthma Institute PLLC

    Chattanooga, Tennessee, 37421

  • Cheraw Pediatrics, P.A.

    Cheraw, South Carolina, 29520

  • Children's Memorial Hospital

    Chicago, Illinois, 60614

  • University Dermatology Consultants, Inc.

    Cincinnati, Ohio, 45219

  • Dermatology Research Associates, Inc.

    Cincinnati, Ohio, 45230

  • Clarksburg Pediatrics, LLC

    Clarksburg, Maryland, 20871

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Clinton Urgent Care

    Clinton, Iowa, 52732

  • Drs. Iacobelli & DiGregorio, PC

    Clinton Township, Michigan, 48038

  • Dermatology Group LLC

    Columbia, South Carolina, 29201

  • McClerklin Skin and Laser Center

    Columbia, South Carolina, 29203

  • Melissa Knuckles

    Corbin, Kentucky, 40701

  • Dermatology Consultants PC

    Covington, Georgia, 30014

  • Allergy Partners North Texas Research

    Dallas, Texas, 75230

  • Dermatology Treatment and Research Center, PA

    Dallas, Texas, 75230

  • Henry Ford Medical Center

    Detroit, Michigan, 48202

  • Dermatology Center for Children and Young Adults

    Eagan, Minnesota, 55121

  • Western Sky Medical Research

    El Paso, Texas, 79903

  • Pediatrx Clinic

    Fayetteville, North Carolina, 28305

  • North County Dermatology

    Florissant, Missouri, 63031

  • Hamzavi Dermatology

    Fort Gratiot, Michigan, 48059

  • Fort Lauderdale Dermatology & Cosmetic Skin Center

    Fort Lauderdale, Florida, 33308

  • Philadelphia Institute of Dermatology

    Fort Washington, Pennsylvania, 19034

  • University of N. Texas Health Science Center

    Fort Worth, Texas, 76107

  • North Texas Institute for Clinical Trials

    Fort Worth, Texas, 76109

  • Tien Nguyen

    Fountain Valley, California, 92708

  • Dermatology Center of Frisco

    Frisco, Texas, 75035

  • Family Allergy & Asthma Care

    Gaithersburg, Maryland, 20878

  • Garden City Dermatology, P.C.

    Garden City, New York, 11530

  • Cheryl D. Ackerman

    Glen Ridge, New Jersey, 07028

  • Callender Skin and Laser Center

    Glenn Dale, Maryland, 20769

  • Rivergate Dermatology Research Center

    Goodlettsville, Tennessee, 37072

  • Silverton Skin Institute

    Grand Blanc, Michigan, 48439

  • Pediatric Dermatology of North Texas PA

    Grapevine, Texas, 76051

  • Allergic Disease & Asthma Center

    Greenville, South Carolina, 29406

  • Stephen Schwartz

    Harlingen, Texas, 78550

  • Connecticut Children's Medical Center Dept of Dermatology

    Hartford, Connecticut, 06106

  • Bettencourt Skin Center

    Henderson, Nevada, 89014

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Webster Dermatology, PA

    Hockessin, Delaware, 19707

  • Hollis Medisys

    Hollis, New York, 11432

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas, 71913

  • Heights Dermatology & Aesthetic Center

    Houston, Texas, 77008

  • University of Texas - Houston

    Houston, Texas, 77030

  • West Houston Dermatology, PA

    Houston, Texas, 77082

  • Bear Creek Clinic, PA

    Houston, Texas, 77084

  • Lone Star Children's Medical PLLC

    Houston, Texas, 77092

  • Ruth A Yates

    Huntsville, Alabama, 35801

  • Southeast Idaho Family Practice

    Idaho Falls, Idaho, 83404

  • Dermatology Associates, PC

    Indianapolis, Indiana, 46240

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46256

  • Dermatology and Laser Center

    Irving, Texas, 75061

  • Site US0048

    Irving, Texas, 75061

  • Asthma & Allergy Center of North Jackson

    Jackson, Mississippi, 39206

  • Peace Children's Clinic

    Jackson, Mississippi, 39216

  • North Florida Dermatology Associates, P.A.

    Jacksonville, Florida, 32204

  • Clinical Partners, LLC

    Johnston, Rhode Island, 02919

  • Dermatology Associates of Kingsport, PC

    Kingsport, Tennessee, 37660

  • Allergy Associates, PA dba East Tennessee Center for Clinical Research

    Knoxville, Tennessee, 37909

  • Dermatology Associates of Knoxville, PC

    Knoxville, Tennessee, 37917

  • The Skin Wellness Center

    Knoxville, Tennessee, 37922

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • South Lincoln Dermatology Clinic

    Lincoln, Nebraska, 68502

  • Marvin S.Watsky

    Lindenhurst, New York, 11757

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Allergy & Asthma Associates of NNM

    Los Alamos, New Mexico, 87544

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • Lubbock Dermatology and Skin Cancer Center

    Lubbock, Texas, 79410

  • Southeastern Dermatology, PA

    Lumberton, North Carolina, 28358

  • Dermatologic Surgery Specialist Inc.

    Macon, Georgia, 31217

  • Univeristy of Wisconsin-Madison

    Madison, Wisconsin, 53792

  • Adult & Pediatric Dermatology

    Marlborough, Massachusetts, 01752

  • Piedmont Dermatology Center, PC

    Martinsville, Virginia, 24112

  • Rick Lin, D.O., MPH

    McAllen, Texas, 78504

  • Sheffield Pediatrics, PLLC

    Memphis, Tennessee, 38104

  • Raleigh Group PC

    Memphis, Tennessee, 38128

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • George V. Chandy MD SC

    Milwaukee, Wisconsin, 53208

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Orange Dermatology Assoc, PC

    Monroe, New York, 10950

  • California Skin Institute

    Mountain View, California, 94040

  • The Dermatology Center

    New Albany, Indiana, 47150

  • Yale University School of Medicine

    New Haven, Connecticut, 06519

  • Kids First Prytania

    New Orleans, Louisiana, 70115

  • St. Luke's Roosevelt Hospital Center

    New York, New York, 10025

  • Columbia University Medical Center., Dept. of Medicine

    New York, New York, 10032

  • MedaPhase,Inc.

    Newnan, Georgia, 30263

  • Michael W. Simon, M.D.

    Nicholasville, Kentucky, 40356

  • Children's Hospital of the Kings Daughters

    Norfolk, Virginia, 23507

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia, 23507

  • National Allergy and Asthma Research, LLC

    North Charleston, South Carolina, 29420

  • Andrea Trowers, MD

    North Miami, Florida, 33181

  • Tory Patrick Sullivan

    North Miami Beach, Florida, 33162

  • Allergy Associates of the Palm Beaches, PA

    North Palm Beach, Florida, 33408

  • East Penn Dermatology

    North Wales, Pennsylvania, 19454

  • Oklahoma University Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Brian Lepley, D.O.

    Oklahoma City, Oklahoma, 73139

  • Family Health Center South

    Oklahoma City, Oklahoma, 73139

  • Skin Specialists PC

    Omaha, Nebraska, 68144

  • All Kids Pediatrics of Opelousas APMC

    Opelousas, Louisiana, 70570

  • Orlando Dermatology

    Orlando, Florida, 32819

  • Midwest Dermatology

    Overland Park, Kansas, 66209

  • Kansas City Dermatology, PA

    Overland Park, Kansas, 66215

  • Donna Zeide

    Palm Beach Gardens, Florida, 33418

  • Pasadena Dermatology Clinic

    Pasadena, Texas, 77506

  • Paddington Testing Co, Inc.

    Philadelphia, Pennsylvania, 19103

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Alliance Dermatology

    Phoenix, Arizona, 85032

  • Derma

    Phoenix, Arizona, 85048

  • Dermatology Center of Indiana P.C.

    Plainfield, Indiana, 46168

  • Waterman Dermatology

    Plantation, Florida, 33324

  • Kenneth M. Reed, MD

    Quincy, Massachusetts, 02169

  • Aistheta

    Reno, Nevada, 89509

  • CDLC

    Ridgewood, New Jersey, 07450

  • Helendale Dermatology & Medical Spa, LLC

    Rochester, New York, 14609

  • Palmetto Skin & Laser Center

    Rock Hill, South Carolina, 29732

  • FMC/OIC

    Rocky Mount, North Carolina, 27801

  • Hull Dermatology, P.A.

    Rogers, Arkansas, 72758

  • Capital Allergy & Respiratory Disease Center

    Roseville, California, 95661

  • Kosse Pediatrics

    Saint Joseph, Missouri, 64506

  • Dermatology Research Center

    Salt Lake City, Utah, 84117

  • Allergy and Immunology Clinic

    San Diego, California, 92111

  • Rady Children's Hospital San Diego

    San Diego, California, 92123

  • California Dermatology Care

    San Ramon, California, 94583

  • AeroAllergy Research Labs of Savannah, Inc.

    Savannah, Georgia, 31406

  • Dermatology Associates, PLLC

    Seattle, Washington, 98101

  • Asthma, Inc.

    Seattle, Washington, 98115

  • Holliway Pediatric Clinic

    Shreveport, Louisiana, 71103

  • Highland Clinic

    Shreveport, Louisiana, 71105

  • Wee Care Pediatrics & Kidmed Clinic

    Shreveport, Louisiana, 71107

  • Healing Hands Family Medicine

    Shreveport, Louisiana, 71129

  • DermAssociates, PC

    Silver Spring, Maryland, 20902

  • Beverly Johnson, MD

    Silver Spring, Maryland, 20904

  • Dimitri Dermatology

    Slidell, Louisiana, 70458

  • Marina I Peredo, MD

    Smithtown, New York, 11787

  • Medical Research Network

    Spring, Texas, 77373

  • SVC Dermatology PC

    Sterling Heights, Michigan, 48314

  • Southern Crescent Dermatology

    Stockbridge, Georgia, 30281

  • Derm Research Center of New York, Inc.

    Stony Brook, New York, 11790

  • Joseph D. Sutton, MD

    Suffern, New York, 10901

  • Olympian Clinical Research

    Tampa, Florida, 33615

  • Dr.Robert A. Norman

    Tampa, Florida, 33626

  • Kansas Medical Clinic, PA

    Topeka, Kansas, 66614

  • Somerset Skin Centre

    Troy, Michigan, 48084

  • OSU-CHS Houston Center Physicians

    Tulsa, Oklahoma, 74127

  • Dermatology Research Associates of Tyler

    Tyler, Texas, 75703

  • Stanley A. Newfield

    Valley Stream, New York, 11581

  • The Dermatology Group, PC

    Verona, New Jersey, 07044

  • Eastern Washington Dermatology

    Walla Walla, Washington, 99362

  • Grekin Skin Institute

    Warren, Michigan, 48093

  • Midwest Center for Dermatology and Cosmetic Surgery

    Warren, Michigan, 48093

  • Warren Dermatology & Allergy

    Warren, Ohio, 44484

  • Randall Dermatology

    West Lafayette, Indiana, 47906

  • Robert S. Berger

    White Plains, Maryland, 20695

  • Mid-Kansas Dermatology Clinic, PA

    Wichita, Kansas, 67206

  • Atlantic Skin & Cosmetic Surgery Group

    Wilmington, Delaware, 19810

  • DermOne Dermatology Center, PA

    Wilmington, North Carolina, 28401

  • Carolina Dermatology & Skin Cancer Surgery

    Wilmington, North Carolina, 28403

  • Knox Clinic Pediatrics, PLLC

    Wilmington, North Carolina, 28403

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany48 sites
  • Licca Fachklinik f. aesthetisch- operative Dermatologie und Chirurgie

    Augsburg, 86179

  • Kinderarztpraxis

    Bamberg, 96050

  • Charite - Universitaetsmedizin Berlin Klinik fuer Dermatologie, Venerologie u. Allergologie

    Berlin, 10117

  • Hautarztpraxis

    Berlin, 13055

  • Hautarztpraxis

    Berlin, 13597

  • Klinik fuer Kinder u. Jugendmedizin der Ruhr Universitaet Bochum im St.-Josef-Hospital

    Bochum, 44791

  • Universitaet Bonn Klinik und Poliklinik fuer Dermatologie

    Bonn, 53105

  • Hautarztpraxis

    Bremen, 28239

  • Hautarztpraxis

    Bremen, 28779

  • Dermatologisches Zentrum Buxtehude

    Buxtehude, 21614

  • Hautarztpraxis

    Crimmitschau, 08451

  • Hautarztpraxis

    Dessau, 06842

  • Hautarztpraxis

    Dresden, 01097

  • Arztpraxis fuer Hautkrankheiten

    Dresden, 01169

  • Klinik und Poliklinik f. Dermatologie Universitaetsklinikum Dresden

    Dresden, 01307

  • Hautklinik

    Düsseldorf, 40225

  • Heinrich-Heine-Universitaet Hautklinik

    Düsseldorf, 40225

  • Hautklinik des Universitaetsklinikums Erlangen

    Erlangen, 91054

  • Falker, Gernot, Hautarztpraxis

    Frankenberg, 35066

  • Universitaetsklinikum Klinische Forschung, Zentrum d. Dermatologie u. Venerologie

    Frankfurt, 60590

  • Derma-Study-Center-Friedrichshafen

    Friedrichshafen, 88045

  • Hautarztpraxis

    Gelnhausen, 63571

  • SRH Wald-Klinikum Gera GmbH

    Gera, 07548

  • Kath. Kinderkrankenhaus Wilhelmstift

    Hamburg, 22149

  • Klinische Forschung Hannover-Mitte GmbH

    Hanover, 30159

  • Brinkmann, Hautarztpraxis

    Herborn, 35745

  • Hautarztpraxis Sempell

    Itzehoe, 25524

  • Klinikum der Fr.-Schiller-Universitaet

    Jena, 07743

  • Universitaet Hautklinik Kiel

    Kiel, 24105

  • DermaKiel-Hautarztpraxis

    Kiel, 24148

  • Klinik fuer Dermatologie, Venerologie u. Allergologie

    Leipzig, 04103

  • Johannes-Gutenberg Universitaet

    Mainz, 55131

  • Universitaetsklinikum Giessen+ Marburg Dermatolgie und Allergologie

    Marburg, 35034

  • Praxis Dermatologie

    Marburg, 35037

  • Hautarztpraxis

    Markkleeberg, 04416

  • Kinder- und Jugendaertzin

    Mönchengladbach, 41066

  • Ludwig - Maximilians Universitaet, Klinik u. Poliklinik fuer Dermatologie u. Allergologie

    München, 80337

  • Universitaetsklinikum Muenster, Klinik & Poliklinik Fuer Hautkrankheiten

    Münster, 48149

  • Proinnovera GmbH

    Münster, 48155

  • Facharzt f. Kinder-und Jugendmedizin

    Münster, 48163

  • Facharzt fuer Kinder-und Jugendmedizin

    Ravensburg, 88212

  • Hautarztpraxis

    Riesa, 01587

  • Richter - Fachaerztin fuer Kinder- und Jugendmedizin

    Solingen, 42697

  • Termeer, Christian

    Stuttgart, 70499

  • Universitaets-Hautklinik Tuebingen

    Tübingen, 72076

  • Marienhospital Wesel Kinderklinik/Forschungsinstitut

    Wesel, 46483

  • Kinderarztpraxis

    Wesseling, 50389

  • Hautarztpraxis

    Wusterwitz, 14789

Other trials in Germany

France24 sites
  • Cabinet Medical

    Amiens, 80090

  • Hopital Pellegrin

    Bordeaux, 33000

  • Cabinet de Dermatologie - Boulogne-Sur-Mer

    Boulogne, 62200

  • Cabinet de Dermatologie - Boulogne

    Boulogne, 92100

  • Hopital Augustin Morvan

    Brest, 29609

  • Cabinet de dermatologie - Cannes

    Cannes, 06400

  • Hopital Trousseau

    Chambray-lès-Tours, 37171

  • Polyclinique du Cotentin

    Équeurdreville-Hainneville, 50120

  • Centre Hospitalier

    Le Mans, 72037

  • Hopital Claude Huriez

    Lille, 59037

  • Cabinet de Dermatologie - Martigues

    Martigues, 13500

  • Hopital de l'Hotel Dieu

    Nantes, 44093

  • Cabinet Dermatologie

    Nantes, 44100

  • Cabinet de Dermatologie

    Nice, 06000

  • Cabinet de Dermatologie - Paris

    Paris, 75007

  • Hospital Saint Louis

    Paris, 75475

  • Hospital Necker

    Paris, 75743

  • CHU La MILETRIE Service de Dermatologie

    Poitiers, 86021

  • HOPITAL CHARLES NICOLLE Service de Dermatologie

    Rouen, 76031

  • Hopital Nord

    Saint-Priest-en-Jarez, 42277

  • Cabinet de Dermatologie-Strasbourg

    Strasbourg, 67000

  • Cabinet de Dermatologie

    Thann, 68800

  • Hopital Larrey

    Toulouse, 31059

  • Centre Hospitalier Service de Dermatologie

    Troyes, 10003

Other trials in France

United Kingdom16 sites
  • Amersham Hospital, Department of Dermatology

    Amersham, HP7 0JD

  • Birmingham Children's Hospital

    Birmingham, B4 6NH

  • Royal Bolton Hospitals Trust

    Bolton, BL4 0JR

  • Addenbrooke's Hospital

    Cambridge, CB2 2QQ

  • Wales College of Medicine, Cardiff University, Heath Park

    Cardiff, CF14 4XN

  • Ninewells Hospital and Medical School

    Dundee, DD1 9SY

  • Royal Infirmary of Edinburgh

    Edinburgh, EH3 9YW

  • Harrogate & District Foundation NHS Trust Hospital

    Harrogate, HG2 7SX

  • Leeds General Infirmary, Dept of Dermatology

    Leeds, LS1 3EX

  • Site UK3007

    Leeds, LS7 4SA

  • Alder Hey Children's Hospital

    Liverpool, L12 2AP

  • Royal Free Hospital

    London, NW3 2QG

  • Department of Pediatric Allergy and Immunology

    Manchester, M13 9WL

  • Chase Farm Hospital

    Middlesex, EN2 8JL

  • George Eliot Hospital

    Nuneaton, CV10 7DJ

  • University of Manchester, Dermatology-Pharmacology Unit Hope Hospital

    Salford, M6 8HD

Other trials in United Kingdom

Poland11 sites
  • Prywatna Praktyka Lekarska "Alergomed"

    Bydgoszcz, 85-077

  • Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego w Bydgoszczy, Wojewodzka Przychodnia Specjalistyczna Dla Dzieci Poradnia ermatologiczna, Budynek "A"

    Bydgoszcz, 85-667

  • Private Practice

    Bydgoszcz, 85-794

  • Szpital Dzieciecy Specjalistyczny Z.O.Z. nad Matka i Dzieckiem

    Gdansk, 80-308

  • Praktyka Lekarska

    Gostynin, 09-500

  • SPZOZ Szpital Specjalistyczny im. S. Zeromskiego

    Krakow, 31-913

  • Dermoklinika

    Lodz, 90-436

  • NZOZ Centrum Alergologii

    Lodz, 90-553

  • Alergovita

    Lublin, 20-803

  • Indywidualna Specjalistyczna Praktyka Lekarska

    Sierpc, 09-200

  • NZOZ Przychodnia Dermatologiczna DERMED s.c

    Torun, 87-100

Other trials in Poland

Canada7 sites
  • Sudbury Skin Clinic

    Greater Sudbury, Ontario, P3E 5M4

  • Eastern Canada Cutaneous Research Association

    Halifax, Nova Scotia, B3H 1Z2

  • Mediprobe Research, Inc.

    London, Ontario, N5X 2P1

  • Lynderm Research, Inc.

    Markham, Ontario, L3P 1X2

  • Nexus Clinical Research

    St. John's, Newfoundland and Labrador, A1A 5E8

  • NewLab Clinical Research, Inc.

    St. John's, Newfoundland and Labrador, A1C 2H5

  • Winnipeg Clinic

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

Austria3 sites
  • LKH Feldkirch

    Feldkirch, 6807

  • Landesfrauen- und -kinderklinik

    Linz, 4020

  • Salzburger Landeskliniken

    Salzburg, 5020

Other trials in Austria

Ireland3 sites
  • South Infirmary

    Cork

  • Our Lady's Hospital for Sick Children

    Dublin, 12

  • The Park Clinic

    Dublin, 18

Other trials in Ireland

Netherlands3 sites
  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Universitair Medisch Centrum St. Radboud

    Nijmegen, 6525 GA

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Keywords
atopic dermatitis, child, tacrolimus ointment, Protopic Ointment
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00475605
Study groupRoleWhat they receive
1. Protopic ExposurePediatric subjects whose ages are/were <16 years at the time of first tacrolimus ointment exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of systemic or cutaneous malignancy

    Standardised Incidence Ratio (versus population cancer rates)

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2007 (estimated)
  2. Study start25 May 2005
  3. Primary completion31 Jan 2019
  4. Study completion31 Jan 2019

Why it stopped: Terminated early, endorsed by the FDA based on futility of continuation.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
8,071 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00475605
Sponsor's protocol ID
F506-CL-5801
Other IDs
FG506-06-37, 03-0-161, EUPAS, LP0156-1294
Acronym
APPLES
Status last verified
Dec 2019
First submitted
17 May 2007
Last updated
18 Dec 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Atopic Dermatitis, run by LEO Pharma at 313 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 313 sites in United States, Germany, France, United Kingdom, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Terminated early, endorsed by the FDA based on futility of continuation.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of systemic or cutaneous malignancy (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00475605, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.

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