Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00475605
Other study ID # F506-CL-5801
Secondary ID FG506-06-3703-0-
Status Terminated
Phase
First received
Last updated
Start date May 25, 2005
Est. completion date January 31, 2019

Study information

Verified date December 2019
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 8071
Est. completion date January 31, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Austria LKH Feldkirch Feldkirch
Austria Landesfrauen- und -kinderklinik Linz
Austria Salzburger Landeskliniken Salzburg
Canada Eastern Canada Cutaneous Research Association Halifax Nova Scotia
Canada Mediprobe Research, Inc. London Ontario
Canada Lynderm Research, Inc. Markham Ontario
Canada NewLab Clinical Research, Inc. St John's Newfoundland and Labrador
Canada Nexus Clinical Research St Johns Newfoundland and Labrador
Canada Sudbury Skin Clinic Sudbury Ontario
Canada Winnipeg Clinic Winnipeg Manitoba
France Cabinet Medical Amiens
France Hopital Pellegrin Bordeaux
France Cabinet de Dermatologie - Boulogne Boulogne
France Cabinet de Dermatologie - Boulogne-Sur-Mer Boulogne
France Hopital Augustin Morvan Brest Cedex 2
France Cabinet de dermatologie - Cannes Cannes
France Hopital Trousseau Chambray Les Tours Cedex
France Polyclinique du Cotentin Équeurdreville-Hainneville
France Centre Hospitalier Le Mans Cedex
France Hopital Claude Huriez Lille Cedex
France Cabinet de Dermatologie - Martigues Martigues
France Cabinet Dermatologie Nantes
France Hopital de l'Hotel Dieu Nantes Cedex 1
France Cabinet de Dermatologie Nice
France Cabinet de Dermatologie - Paris Paris
France Hospital Saint Louis Paris Cedex 10
France Hospital Necker Paris Cedex 15
France CHU La MILETRIE Service de Dermatologie Poitiers Cedex
France HOPITAL CHARLES NICOLLE Service de Dermatologie Rouen Cedex
France Hopital Nord St. Priest En Jarez Cedex
France Cabinet de Dermatologie-Strasbourg Strasbourg
France Cabinet de Dermatologie Thann
France Hopital Larrey Toulouse Cedex 9
France Centre Hospitalier Service de Dermatologie Troyes Cedex
Germany Licca Fachklinik f. aesthetisch- operative Dermatologie und Chirurgie Augsburg
Germany Kinderarztpraxis Bamberg
Germany Charite - Universitaetsmedizin Berlin Klinik fuer Dermatologie, Venerologie u. Allergologie Berlin
Germany Hautarztpraxis Berlin
Germany Hautarztpraxis Berlin
Germany Klinik fuer Kinder u. Jugendmedizin der Ruhr Universitaet Bochum im St.-Josef-Hospital Bochum
Germany Universitaet Bonn Klinik und Poliklinik fuer Dermatologie Bonn
Germany Hautarztpraxis Bremen
Germany Hautarztpraxis Bremen
Germany Dermatologisches Zentrum Buxtehude Buxtehude
Germany Hautarztpraxis Crimmitschau
Germany Hautarztpraxis Dessau
Germany Arztpraxis fuer Hautkrankheiten Dresden
Germany Hautarztpraxis Dresden
Germany Klinik und Poliklinik f. Dermatologie Universitaetsklinikum Dresden Dresden
Germany Hautklinik Duesseldorf
Germany Heinrich-Heine-Universitaet Hautklinik Duesseldorf
Germany Hautklinik des Universitaetsklinikums Erlangen Erlangen
Germany Falker, Gernot, Hautarztpraxis Frankenberg
Germany Universitaetsklinikum Klinische Forschung, Zentrum d. Dermatologie u. Venerologie Frankfurt
Germany Derma-Study-Center-Friedrichshafen Friedrichshafen
Germany Hautarztpraxis Gelnhausen
Germany SRH Wald-Klinikum Gera GmbH Gera
Germany Kath. Kinderkrankenhaus Wilhelmstift Hamburg
Germany Klinische Forschung Hannover-Mitte GmbH Hannover
Germany Brinkmann, Hautarztpraxis Herborn
Germany Hautarztpraxis Sempell Itzehoe
Germany Klinikum der Fr.-Schiller-Universitaet Jena
Germany DermaKiel-Hautarztpraxis Kiel
Germany Universitaet Hautklinik Kiel Kiel
Germany Klinik fuer Dermatologie, Venerologie u. Allergologie Leipzig
Germany Johannes-Gutenberg Universitaet Mainz
Germany Praxis Dermatologie Marburg
Germany Universitaetsklinikum Giessen+ Marburg Dermatolgie und Allergologie Marburg
Germany Hautarztpraxis Markkleeberg
Germany Kinder- und Jugendaertzin Moenchengladbach
Germany Ludwig - Maximilians Universitaet, Klinik u. Poliklinik fuer Dermatologie u. Allergologie Muenchen
Germany Facharzt f. Kinder-und Jugendmedizin Muenster
Germany Proinnovera GmbH Muenster
Germany Universitaetsklinikum Muenster, Klinik & Poliklinik Fuer Hautkrankheiten Muenster
Germany Facharzt fuer Kinder-und Jugendmedizin Ravensburg
Germany Hautarztpraxis Riesa
Germany Richter - Fachaerztin fuer Kinder- und Jugendmedizin Solingen
Germany Termeer, Christian Stuttgart
Germany Universitaets-Hautklinik Tuebingen Tuebingen
Germany Marienhospital Wesel Kinderklinik/Forschungsinstitut Wesel
Germany Kinderarztpraxis Wesseling
Germany Hautarztpraxis Wusterwitz
Ireland South Infirmary Cork
Ireland Our Lady's Hospital for Sick Children Dublin
Ireland The Park Clinic Dublin
Netherlands Academisch Medisch Centrum Amsterdam
Netherlands Universitair Medisch Centrum Groningen Groningen
Netherlands Universitair Medisch Centrum St. Radboud Nijmegen
Poland Private Practice Bydgoszcz
Poland Prywatna Praktyka Lekarska "Alergomed" Bydgoszcz
Poland Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego w Bydgoszczy, Wojewodzka Przychodnia Specjalistyczna Dla Dzieci Poradnia ermatologiczna, Budynek "A" Bydgoszcz
Poland Szpital Dzieciecy Specjalistyczny Z.O.Z. nad Matka i Dzieckiem Gdansk
Poland Praktyka Lekarska Gostynin
Poland SPZOZ Szpital Specjalistyczny im. S. Zeromskiego Krakow
Poland Dermoklinika Lodz
Poland NZOZ Centrum Alergologii Lodz
Poland Alergovita Lublin
Poland Indywidualna Specjalistyczna Praktyka Lekarska Sierpc
Poland NZOZ Przychodnia Dermatologiczna DERMED s.c Torun
United Kingdom Amersham Hospital, Department of Dermatology Amersham
United Kingdom Birmingham Children's Hospital Birmingham
United Kingdom Royal Bolton Hospitals Trust Bolton
United Kingdom Addenbrooke's Hospital Cambridge
United Kingdom Wales College of Medicine, Cardiff University, Heath Park Cardiff
United Kingdom Ninewells Hospital and Medical School Dundee
United Kingdom Royal Infirmary of Edinburgh Edinburgh
United Kingdom Harrogate & District Foundation NHS Trust Hospital Harrogate
United Kingdom Leeds General Infirmary, Dept of Dermatology Leeds
United Kingdom Site UK3007 Leeds
United Kingdom Alder Hey Children's Hospital Liverpool
United Kingdom Royal Free Hospital London
United Kingdom Department of Pediatric Allergy and Immunology Manchester
United Kingdom Chase Farm Hospital Middlesex
United Kingdom George Eliot Hospital Nuneaton
United Kingdom University of Manchester, Dermatology-Pharmacology Unit Hope Hospital Salford
United States Paul S. Takiguchi- MD- Inc. 'Aiea Hawaii
United States Wayne Fujita, M.D. - Private Practice 'Aiea Hawaii
United States Davie Dermatology Advance North Carolina
United States Shelby Dermatology Alabaster Alabama
United States Georgia Pollens Clinical Research Centers, Inc Albany Georgia
United States University of New Mexico Albuquerque New Mexico
United States Pediatric Care Center of NE Alabama Anniston Alabama
United States Academy of Clinical Research Arlington Texas
United States Arlington Center for Dermatology Arlington Texas
United States Glenn H. Fuchs, MD PC Arlington Virginia
United States Emory University Atlanta Georgia
United States Zoltan Trizna Austin Texas
United States Johns Hopkins University, Division of Pediatric Dermatolgy Baltimore Maryland
United States LA Dermatology Assoc LLC Baton Rouge Louisiana
United States New York Dermatology, P.C. Bayside New York
United States Haber Dermatology and Cosmetic Surgery, Inc Beachwood Ohio
United States DermAssociates LTD Belleville Illinois
United States Brookside Pediatrics Bennington Vermont
United States Metro Pediatrics, P.C Birmingham Alabama
United States Pediatric & Adult Asthma and Allergy, P.C. Birmingham Alabama
United States Skin Wellness Center of Alabama Birmingham Alabama
United States Southview Dermatology Birmingham Alabama
United States Total Skin and Beauty Dermatology Center Birmingham Alabama
United States Center for Dermatology Boca Raton Florida
United States Dermatology Clinic of Idaho Boise Idaho
United States Boston Children's Hospital Boston Massachusetts
United States Angelos Koutsonikolis, MD, PA Boynton Beach Florida
United States Joshua Berlin P.A. Boynton Beach Florida
United States Morris Westfried, M.D. Brooklyn New York
United States Robert S. Darr, MD, PC Brooklyn New York
United States Alamance Skin Center Burlington North Carolina
United States Coastal Allergy Care Camarillo California
United States Dermatology, Inc. Carmel Indiana
United States Shideler Clinical Research Center Carmel Indiana
United States Central Wyoming Skin Clinic Casper Wyoming
United States Dermatology Assoc of Northern Vineland Centreville Virginia
United States Christie Clinic Champaign Illinois
United States Dermatology and Laser Center of Charleston Charleston South Carolina
United States The Asthma Institute PLLC Chattanooga Tennessee
United States Cheraw Pediatrics, P.A. Cheraw South Carolina
United States Children's Memorial Hospital Chicago Illinois
United States Dermatology Research Associates, Inc. Cincinnati Ohio
United States University Dermatology Consultants, Inc. Cincinnati Ohio
United States Clarksburg Pediatrics, LLC Clarksburg Maryland
United States Cleveland Clinic Foundation Cleveland Ohio
United States Clinton Urgent Care Clinton Iowa
United States Drs. Iacobelli & DiGregorio, PC Clinton Township Michigan
United States Dermatology Group LLC Columbia South Carolina
United States McClerklin Skin and Laser Center Columbia South Carolina
United States Melissa Knuckles Corbin Kentucky
United States Dermatology Consultants PC Covington Georgia
United States Allergy Partners North Texas Research Dallas Texas
United States Dermatology Treatment and Research Center, PA Dallas Texas
United States Henry Ford Medical Center Detroit Michigan
United States Dermatology Center for Children and Young Adults Eagan Minnesota
United States Western Sky Medical Research El Paso Texas
United States Pediatrx Clinic Fayetteville North Carolina
United States North County Dermatology Florissant Missouri
United States Hamzavi Dermatology Fort Gratiot Michigan
United States Fort Lauderdale Dermatology & Cosmetic Skin Center Fort Lauderdale Florida
United States Philadelphia Institute of Dermatology Fort Washington Pennsylvania
United States North Texas Institute for Clinical Trials Fort Worth Texas
United States University of N. Texas Health Science Center Fort Worth Texas
United States Tien Nguyen Fountain Valley California
United States Dermatology Center of Frisco Frisco Texas
United States Family Allergy & Asthma Care Gaithersburg Maryland
United States Garden City Dermatology, P.C. Garden City New York
United States Cheryl D. Ackerman Glen Ridge New Jersey
United States Callender Skin and Laser Center Glenn Dale Maryland
United States Rivergate Dermatology Research Center Goodlettsville Tennessee
United States Silverton Skin Institute Grand Blanc Michigan
United States Pediatric Dermatology of North Texas PA Grapevine Texas
United States Allergic Disease & Asthma Center Greenville South Carolina
United States Stephen Schwartz Harlingen Texas
United States Connecticut Children's Medical Center Dept of Dermatology Hartford Connecticut
United States Bettencourt Skin Center Henderson Nevada
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
United States Webster Dermatology, PA Hockessin Delaware
United States Hollis Medisys Hollis New York
United States Burke Pharmaceutical Research Hot Springs Arkansas
United States Bear Creek Clinic, PA Houston Texas
United States Heights Dermatology & Aesthetic Center Houston Texas
United States Lone Star Children's Medical PLLC Houston Texas
United States University of Texas - Houston Houston Texas
United States West Houston Dermatology, PA Houston Texas
United States Ruth A Yates Huntsville Alabama
United States Southeast Idaho Family Practice Idaho Falls Idaho
United States Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana
United States Dermatology Associates, PC Indianapolis Indiana
United States Dermatology and Laser Center Irving Texas
United States Site US0048 Irving Texas
United States Asthma & Allergy Center of North Jackson Jackson Mississippi
United States Peace Children's Clinic Jackson Mississippi
United States North Florida Dermatology Associates, P.A. Jacksonville Florida
United States Clinical Partners, LLC Johnston Rhode Island
United States Dermatology Associates of Kingsport, PC Kingsport Tennessee
United States Allergy Associates, PA dba East Tennessee Center for Clinical Research Knoxville Tennessee
United States Dermatology Associates of Knoxville, PC Knoxville Tennessee
United States The Skin Wellness Center Knoxville Tennessee
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States South Lincoln Dermatology Clinic Lincoln Nebraska
United States Marvin S.Watsky Lindenhurst New York
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Allergy & Asthma Associates of NNM Los Alamos New Mexico
United States Dermatology Research Associates Los Angeles California
United States Lubbock Dermatology and Skin Cancer Center Lubbock Texas
United States Southeastern Dermatology, PA Lumberton North Carolina
United States Dermatologic Surgery Specialist Inc. Macon Georgia
United States Univeristy of Wisconsin-Madison Madison Wisconsin
United States Adult & Pediatric Dermatology Marlborough Massachusetts
United States Piedmont Dermatology Center, PC Martinsville Virginia
United States Rick Lin, D.O., MPH McAllen Texas
United States Raleigh Group PC Memphis Tennessee
United States Sheffield Pediatrics, PLLC Memphis Tennessee
United States University of Miami Miller School of Medicine Miami Florida
United States George V. Chandy MD SC Milwaukee Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States Orange Dermatology Assoc, PC Monroe New York
United States California Skin Institute Mountain View California
United States The Dermatology Center New Albany Indiana
United States Yale University School of Medicine New Haven Connecticut
United States Kids First Prytania New Orleans Louisiana
United States Columbia University Medical Center., Dept. of Medicine New York New York
United States St. Luke's Roosevelt Hospital Center New York New York
United States MedaPhase,Inc. Newnan Georgia
United States Michael W. Simon, M.D. Nicholasville Kentucky
United States Children's Hospital of the Kings Daughters Norfolk Virginia
United States Virginia Clinical Research, Inc. Norfolk Virginia
United States National Allergy and Asthma Research, LLC North Charleston South Carolina
United States Andrea Trowers, MD North Miami Florida
United States Tory Patrick Sullivan North Miami Beach Florida
United States Allergy Associates of the Palm Beaches, PA North Palm Beach Florida
United States East Penn Dermatology North Wales Pennsylvania
United States Brian Lepley, D.O. Oklahoma City Oklahoma
United States Family Health Center South Oklahoma City Oklahoma
United States Oklahoma University Health Sciences Center Oklahoma City Oklahoma
United States Skin Specialists PC Omaha Nebraska
United States All Kids Pediatrics of Opelousas APMC Opelousas Louisiana
United States Orlando Dermatology Orlando Florida
United States Kansas City Dermatology, PA Overland Park Kansas
United States Midwest Dermatology Overland Park Kansas
United States Donna Zeide Palm Beach Gardens Florida
United States Pasadena Dermatology Clinic Pasadena Texas
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Paddington Testing Co, Inc. Philadelphia Pennsylvania
United States Alliance Dermatology Phoenix Arizona
United States Derma Phoenix Arizona
United States Dermatology Center of Indiana P.C. Plainfield Indiana
United States Waterman Dermatology Plantation Florida
United States Kenneth M. Reed, MD Quincy Massachusetts
United States Aistheta Reno Nevada
United States CDLC Ridgewood New Jersey
United States Helendale Dermatology & Medical Spa, LLC Rochester New York
United States Palmetto Skin & Laser Center Rock Hill South Carolina
United States FMC/OIC Rocky Mount North Carolina
United States Hull Dermatology, P.A. Rogers Arkansas
United States Capital Allergy & Respiratory Disease Center Roseville California
United States Kosse Pediatrics Saint Joseph Missouri
United States Dermatology Research Center Salt Lake City Utah
United States Allergy and Immunology Clinic San Diego California
United States Rady Children's Hospital San Diego San Diego California
United States California Dermatology Care San Ramon California
United States AeroAllergy Research Labs of Savannah, Inc. Savannah Georgia
United States Asthma, Inc. Seattle Washington
United States Dermatology Associates, PLLC Seattle Washington
United States Healing Hands Family Medicine Shreveport Louisiana
United States Highland Clinic Shreveport Louisiana
United States Holliway Pediatric Clinic Shreveport Louisiana
United States Wee Care Pediatrics & Kidmed Clinic Shreveport Louisiana
United States Beverly Johnson, MD Silver Spring Maryland
United States DermAssociates, PC Silver Spring Maryland
United States Dimitri Dermatology Slidell Louisiana
United States Marina I Peredo, MD Smithtown New York
United States Medical Research Network Spring Texas
United States SVC Dermatology PC Sterling Heights Michigan
United States Southern Crescent Dermatology Stockbridge Georgia
United States Derm Research Center of New York, Inc. Stony Brook New York
United States Joseph D. Sutton, MD Suffern New York
United States Dr.Robert A. Norman Tampa Florida
United States Olympian Clinical Research Tampa Florida
United States Kansas Medical Clinic, PA Topeka Kansas
United States Somerset Skin Centre Troy Michigan
United States OSU-CHS Houston Center Physicians Tulsa Oklahoma
United States Dermatology Research Associates of Tyler Tyler Texas
United States Stanley A. Newfield Valley Stream New York
United States The Dermatology Group, PC Verona New Jersey
United States Eastern Washington Dermatology Walla Walla Washington
United States Grekin Skin Institute Warren Michigan
United States Midwest Center for Dermatology and Cosmetic Surgery Warren Michigan
United States Warren Dermatology & Allergy Warren Ohio
United States Randall Dermatology West Lafayette Indiana
United States Robert S. Berger White Plains Maryland
United States Mid-Kansas Dermatology Clinic, PA Wichita Kansas
United States Atlantic Skin & Cosmetic Surgery Group Wilmington Delaware
United States Carolina Dermatology & Skin Cancer Surgery Wilmington North Carolina
United States DermOne Dermatology Center, PA Wilmington North Carolina
United States Knox Clinic Pediatrics, PLLC Wilmington North Carolina
United States Wake Forest University School of Medicine Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
LEO Pharma

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Germany,  Ireland,  Netherlands,  Poland,  United Kingdom, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of systemic or cutaneous malignancy Standardised Incidence Ratio (versus population cancer rates) 10 years
See also
  Status Clinical Trial Phase
Completed NCT05018806 - Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis Phase 2
Terminated NCT03847389 - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis Phase 1/Phase 2
Completed NCT04090229 - A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis Phase 1
Active, not recruiting NCT05388760 - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) Phase 2
Completed NCT05530707 - Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer N/A
Completed NCT02595073 - Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis Phase 3
Recruiting NCT05509023 - Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD) Phase 2
Recruiting NCT05048056 - Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis Phase 2
Completed NCT04598269 - Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis Phase 2
Recruiting NCT03936335 - An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Withdrawn NCT03089476 - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy N/A
Recruiting NCT05029895 - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated NCT03654755 - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT04556461 - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function Phase 2
Recruiting NCT04818138 - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort N/A
Completed NCT03719742 - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer N/A
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03441568 - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control N/A
Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2