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.
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
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
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
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
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
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
Austria3 sites
LKH Feldkirch
Feldkirch, 6807
Landesfrauen- und -kinderklinik
Linz, 4020
Salzburger Landeskliniken
Salzburg, 5020
Ireland3 sites
South Infirmary
Cork
Our Lady's Hospital for Sick Children
Dublin, 12
The Park Clinic
Dublin, 18
Netherlands3 sites
Academisch Medisch Centrum
Amsterdam, 1105 AZ
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Universitair Medisch Centrum St. Radboud
Nijmegen, 6525 GA
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.
- Conditions
- Atopic Dermatitis
- 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 group | Role | What they receive |
|---|---|---|
| 1. Protopic Exposure | Pediatric 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.
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.
- First posted21 May 2007 (estimated)
- Study start25 May 2005
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Why it stopped: Terminated early, endorsed by the FDA based on futility of continuation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- LEO Pharma A/S, Study director, Medical Expert
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00475605
- Acronym / sponsor ID
- APPLES / F506-CL-5801
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, child, tacrolimus ointment, Protopic Ointment
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated early, endorsed by the FDA based on futility of continuation.
- Enrolment
- 8,071 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 25 May 2005 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 21 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. Protopic Exposure | – | –Pediatric subjects whose ages are/were <16 years at the time of first tacrolimus ointment exposure |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric subjects whose ages are/were <16 years at the time of first tacrolimus ointment exposure
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of systemic or cutaneous malignancy
Time frame: 10 years
Standardised Incidence Ratio (versus population cancer rates)
Results and safety
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.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Results publicationD3T01.1J 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LEO Pharma A/S study director
Medical Expert
313 sites in 9 countries: see every site and its status.
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.