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ClinicalTrials.gov record
Terminated No phase listed Observational

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

ClinicalTrials.gov ID: NCT00475605

Public ClinicalTrials.gov record NCT00475605. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 5:17 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were \< 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.

Study identification

NCT ID
NCT00475605
Recruitment status
Terminated
Study type
Observational
Phase
Not listed
Lead sponsor
LEO Pharma
Industry
Enrollment
8,071 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
Up to 16 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 25, 2005 (Actual)
Primary completion
Jan 31, 2019 (Actual)
Completion
Jan 31, 2019 (Actual)
Last update posted
Dec 18, 2019

2005 – 2019

United States locations

U.S. sites
198
U.S. states
42
U.S. cities
158
Facility City State ZIP Site status
Shelby Dermatology Alabaster Alabama 35007 —
Pediatric Care Center of NE Alabama Anniston Alabama 36207 —
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 —
Ruth A Yates Huntsville Alabama 35801 —
Alliance Dermatology Phoenix Arizona 85032 —
Derma Phoenix Arizona 85048 —
Burke Pharmaceutical Research Hot Springs Arkansas 71913 —
University of Arkansas for Medical Sciences Little Rock Arkansas 72205 —
Hull Dermatology, P.A. Rogers Arkansas 72758 —
Coastal Allergy Care Camarillo California 93010 —
Tien Nguyen Fountain Valley California 92708 —
Dermatology Research Associates Los Angeles California 90045 —
California Skin Institute Mountain View California 94040 —
Capital Allergy & Respiratory Disease Center Roseville California 95661 —
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 —
Connecticut Children's Medical Center Dept of Dermatology Hartford Connecticut 06106 —
Yale University School of Medicine New Haven Connecticut 06519 —
Webster Dermatology, PA Hockessin Delaware 19707 —
Atlantic Skin & Cosmetic Surgery Group Wilmington Delaware 19810 —
Center for Dermatology Boca Raton Florida 33428 —
Angelos Koutsonikolis, MD, PA Boynton Beach Florida 33437 —
Joshua Berlin P.A. Boynton Beach Florida 33437 —
Fort Lauderdale Dermatology & Cosmetic Skin Center Fort Lauderdale Florida 33308 —
North Florida Dermatology Associates, P.A. Jacksonville Florida 32204 —
University of Miami Miller School of Medicine Miami Florida 33136 —
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 —
Orlando Dermatology Orlando Florida 32819 —
Donna Zeide Palm Beach Gardens Florida 33418 —
Waterman Dermatology Plantation Florida 33324 —
Olympian Clinical Research Tampa Florida 33615 —
Dr.Robert A. Norman Tampa Florida 33626 —
Georgia Pollens Clinical Research Centers, Inc Albany Georgia 31707 —
Emory University Atlanta Georgia 30322 —
Dermatology Consultants PC Covington Georgia 30014 —
Dermatologic Surgery Specialist Inc. Macon Georgia 31217 —
MedaPhase,Inc. Newnan Georgia 30263 —
AeroAllergy Research Labs of Savannah, Inc. Savannah Georgia 31406 —
Southern Crescent Dermatology Stockbridge Georgia 30281 —
Paul S. Takiguchi- MD- Inc. ‘Aiea Hawaii 96701 —
Wayne Fujita, M.D. - Private Practice ‘Aiea Hawaii 96701 —
Dermatology Clinic of Idaho Boise Idaho 83704 —
Southeast Idaho Family Practice Idaho Falls Idaho 83404 —
DermAssociates LTD Belleville Illinois 62226 —
Christie Clinic Champaign Illinois 61820 —
Children's Memorial Hospital Chicago Illinois 60614 —
Dermatology, Inc. Carmel Indiana 46032 —
Shideler Clinical Research Center Carmel Indiana 46032 —
Dermatology Associates, PC Indianapolis Indiana 46240 —
Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana 46256 —
The Dermatology Center New Albany Indiana 47150 —
Dermatology Center of Indiana P.C. Plainfield Indiana 46168 —
Randall Dermatology West Lafayette Indiana 47906 —
Clinton Urgent Care Clinton Iowa 52732 —
Midwest Dermatology Overland Park Kansas 66209 —
Kansas City Dermatology, PA Overland Park Kansas 66215 —
Kansas Medical Clinic, PA Topeka Kansas 66614 —
Mid-Kansas Dermatology Clinic, PA Wichita Kansas 67206 —
Melissa Knuckles Corbin Kentucky 40701 —
Michael W. Simon, M.D. Nicholasville Kentucky 40356 —
LA Dermatology Assoc LLC Baton Rouge Louisiana 70809 —
Kids First Prytania New Orleans Louisiana 70115 —
All Kids Pediatrics of Opelousas APMC Opelousas Louisiana 70570 —
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 —
Dimitri Dermatology Slidell Louisiana 70458 —
Johns Hopkins University, Division of Pediatric Dermatolgy Baltimore Maryland 21287 —
Clarksburg Pediatrics, LLC Clarksburg Maryland 20871 —
Family Allergy & Asthma Care Gaithersburg Maryland 20878 —
Callender Skin and Laser Center Glenn Dale Maryland 20769 —
DermAssociates, PC Silver Spring Maryland 20902 —
Beverly Johnson, MD Silver Spring Maryland 20904 —
Robert S. Berger White Plains Maryland 20695 —
Boston Children's Hospital Boston Massachusetts 02115 —
Adult & Pediatric Dermatology Marlborough Massachusetts 01752 —
Kenneth M. Reed, MD Quincy Massachusetts 02169 —
Drs. Iacobelli & DiGregorio, PC Clinton Township Michigan 48038 —
Henry Ford Medical Center Detroit Michigan 48202 —
Hamzavi Dermatology Fort Gratiot Michigan 48059 —
Silverton Skin Institute Grand Blanc Michigan 48439 —
SVC Dermatology PC Sterling Heights Michigan 48314 —
Somerset Skin Centre Troy Michigan 48084 —
Grekin Skin Institute Warren Michigan 48093 —
Midwest Center for Dermatology and Cosmetic Surgery Warren Michigan 48093 —
Dermatology Center for Children and Young Adults Eagan Minnesota 55121 —
University of Minnesota Minneapolis Minnesota 55455 —
Asthma & Allergy Center of North Jackson Jackson Mississippi 39206 —
Peace Children's Clinic Jackson Mississippi 39216 —
North County Dermatology Florissant Missouri 63031 —
Kosse Pediatrics Saint Joseph Missouri 64506 —
South Lincoln Dermatology Clinic Lincoln Nebraska 68502 —
Skin Specialists PC Omaha Nebraska 68144 —
Bettencourt Skin Center Henderson Nevada 89014 —
Aistheta Reno Nevada 89509 —
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03756 —
Cheryl D. Ackerman Glen Ridge New Jersey 07028 —
CDLC Ridgewood New Jersey 07450 —
The Dermatology Group, PC Verona New Jersey 07044 —
University of New Mexico Albuquerque New Mexico 87131 —
Allergy & Asthma Associates of NNM Los Alamos New Mexico 87544 —
New York Dermatology, P.C. Bayside New York 11360 —
Robert S. Darr, MD, PC Brooklyn New York 11209 —
Morris Westfried, M.D. Brooklyn New York 11228 —
Garden City Dermatology, P.C. Garden City New York 11530 —
Hollis Medisys Hollis New York 11432 —
Marvin S.Watsky Lindenhurst New York 11757 —
Orange Dermatology Assoc, PC Monroe New York 10950 —
St. Luke's Roosevelt Hospital Center New York New York 10025 —
Columbia University Medical Center., Dept. of Medicine New York New York 10032 —
Helendale Dermatology & Medical Spa, LLC Rochester New York 14609 —
Marina I Peredo, MD Smithtown New York 11787 —
Derm Research Center of New York, Inc. Stony Brook New York 11790 —
Joseph D. Sutton, MD Suffern New York 10901 —
Stanley A. Newfield Valley Stream New York 11581 —
Davie Dermatology Advance North Carolina 27006 —
Alamance Skin Center Burlington North Carolina 27215 —
Pediatrx Clinic Fayetteville North Carolina 28305 —
Southeastern Dermatology, PA Lumberton North Carolina 28358 —
FMC/OIC Rocky Mount North Carolina 27801 —
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 —
Haber Dermatology and Cosmetic Surgery, Inc Beachwood Ohio 44122 —
University Dermatology Consultants, Inc. Cincinnati Ohio 45219 —
Dermatology Research Associates, Inc. Cincinnati Ohio 45230 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
Warren Dermatology & Allergy Warren Ohio 44484 —
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 —
OSU-CHS Houston Center Physicians Tulsa Oklahoma 74127 —
Philadelphia Institute of Dermatology Fort Washington Pennsylvania 19034 —
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania 17033 —
East Penn Dermatology North Wales Pennsylvania 19454 —
Paddington Testing Co, Inc. Philadelphia Pennsylvania 19103 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Clinical Partners, LLC Johnston Rhode Island 02919 —
Dermatology and Laser Center of Charleston Charleston South Carolina 29414 —
Cheraw Pediatrics, P.A. Cheraw South Carolina 29520 —
Dermatology Group LLC Columbia South Carolina 29201 —
McClerklin Skin and Laser Center Columbia South Carolina 29203 —
Allergic Disease & Asthma Center Greenville South Carolina 29406 —
National Allergy and Asthma Research, LLC North Charleston South Carolina 29420 —
Palmetto Skin & Laser Center Rock Hill South Carolina 29732 —
The Asthma Institute PLLC Chattanooga Tennessee 37421 —
Rivergate Dermatology Research Center Goodlettsville Tennessee 37072 —
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 —
Sheffield Pediatrics, PLLC Memphis Tennessee 38104 —
Raleigh Group PC Memphis Tennessee 38128 —
Academy of Clinical Research Arlington Texas 76002 —
Arlington Center for Dermatology Arlington Texas 76011 —
Zoltan Trizna Austin Texas 78759 —
Allergy Partners North Texas Research Dallas Texas 75230 —
Dermatology Treatment and Research Center, PA Dallas Texas 75230 —
Western Sky Medical Research El Paso Texas 79903 —
University of N. Texas Health Science Center Fort Worth Texas 76107 —
North Texas Institute for Clinical Trials Fort Worth Texas 76109 —
Dermatology Center of Frisco Frisco Texas 75035 —
Pediatric Dermatology of North Texas PA Grapevine Texas 76051 —
Stephen Schwartz Harlingen Texas 78550 —
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 —
Dermatology and Laser Center Irving Texas 75061 —
Site US0048 Irving Texas 75061 —
Lubbock Dermatology and Skin Cancer Center Lubbock Texas 79410 —
Rick Lin, D.O., MPH McAllen Texas 78504 —
Pasadena Dermatology Clinic Pasadena Texas 77506 —
Medical Research Network Spring Texas 77373 —
Dermatology Research Associates of Tyler Tyler Texas 75703 —
Dermatology Research Center Salt Lake City Utah 84117 —
Brookside Pediatrics Bennington Vermont 05201 —
Glenn H. Fuchs, MD PC Arlington Virginia 22204 —
Dermatology Assoc of Northern Vineland Centreville Virginia 20121 —
Piedmont Dermatology Center, PC Martinsville Virginia 24112 —
Children's Hospital of the Kings Daughters Norfolk Virginia 23507 —
Virginia Clinical Research, Inc. Norfolk Virginia 23507 —
Dermatology Associates, PLLC Seattle Washington 98101 —
Asthma, Inc. Seattle Washington 98115 —
Eastern Washington Dermatology Walla Walla Washington 99362 —
Univeristy of Wisconsin-Madison Madison Wisconsin 53792 —
George V. Chandy MD SC Milwaukee Wisconsin 53208 —
Central Wyoming Skin Clinic Casper Wyoming 82609 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 115 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00475605, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 18, 2019 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00475605 live on ClinicalTrials.gov.

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