Know Cancer

forgot password

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

16 Years
Open (Enrolling)
Atopic Dermatitis

Thank you

Trial Information

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

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

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The endpoint is the occurrence of serious adverse events, including the observation of systemic and cutaneous malignancies

Outcome Time Frame:

At six month intervals for ten years

Safety Issue:


Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development


United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

August 2022

Related Keywords:

  • Atopic Dermatitis
  • Protopic Ointment
  • tacrolimus ointment
  • atopic dermatitis
  • child
  • Dermatitis
  • Dermatitis, Atopic



Cleveland Clinic Foundation Cleveland, Ohio  44195
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
University of Minnesota Minneapolis, Minnesota  55455
Emory University Atlanta, Georgia  30322
Children's Memorial Hospital Chicago, Illinois  60614
University of New Mexico Albuquerque, New Mexico  87131
Oklahoma University Health Sciences Center Oklahoma City, Oklahoma  73104
Yale University School Of Medicine New Haven, Connecticut  06520
Wake Forest University School of Medicine Winston-Salem, North Carolina  27157-1023
Highland Clinic Shreveport, Louisiana  71105
North Florida Dermatology Associates, P.A. Jacksonville, Florida  32204
Henry Ford Medical Center Dearborn, Michigan  48126
Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Total Skin and Beauty Dermatology Center Birmingham, Alabama  35205
Christie Clinic Champaign, Illinois  61820
Dawes Fretzin Clinical Research Group, LLC Indianapolis, Indiana  46256
Dermatology Associates, PC Indianapolis, Indiana  46240
Kansas City Dermatology, PA Overland Park, Kansas  66215
Callender Skin and Laser Center Mitchellville, Maryland  20721
Somerset Skin Centre Troy, Michigan  48084
University Dermatology Consultants, Inc. Cincinnati, Ohio  45242
Clinical Partners, LLC Johnston, Rhode Island  02919
Dermatology Associates of Kingsport, PC Kingsport, Tennessee  37660
West Houston Dermatology, PA Houston, Texas  77082
Eastern Washington Dermatology Dayton, Washington  99328
Dermatology Associates, PLLC Seattle, Washington  98101
Melissa Knuckles Corbin, Kentucky  40701
University Of Miami Miller School Of Medicine Miami, Florida  33010
Virginia Clinical Research, Inc. Norfolk, Virginia  23507
Children's Hospital of the Kings Daughters Norfolk, Virginia  23507
St. Luke's Roosevelt Hospital Center New York, New York  10019
Rady Children's Hospital San Diego San Diego, California  92123
University of Texas - Houston Houston, Texas  77030
Ruth A Yates Huntsville, Alabama  35801
California Skin Institute Mountain View, California  94040
Center for Dermatology Boca Raton, Florida  33428
Dermatologic Surgery Specialist Inc. Macon, Georgia  31217
Paul S. Takiguchi- MD- Inc. Aiea, Hawaii  96701
Randall Dermatology West Lafayette, Indiana  47906
Kansas Medical Clinic, PA Topeka, Kansas  66614
LA Dermatology Assoc LLC Baton Rouge, Louisiana  70809
Dimitri Dermatology Gretna, Louisiana  70056
Kenneth M. Reed, MD Quincy, Massachusetts  02169
Drs. Iacobelli & DiGregorio, PC Clinton Township, Michigan  48038
Midwest Center for Dermatology and Cosmetic Surgery Warren, Michigan  48093
Garden City Dermatology, P.C. Garden City, New York  11530
Orange Dermatology Assoc, PC Monroe, New York  10950
Marina I Peredo, MD Smithtown, New York  11787
Joseph D. Sutton, MD Suffern, New York  10901
Stanley A. Newfield Valley Stream, New York  11581
Davie Dermatology Advance, North Carolina  27006
Atlantic Dermatology Associates, P.A. Wilmington, North Carolina  28401
East Penn Dermatology North Wales, Pennsylvania  19454
Paddington Testing Co, Inc. Philadelphia, Pennsylvania  19103
McClerklin Skin and Laser Center Columbia, South Carolina  29203
Rivergate Dermatology Research Center Goodlettsville, Tennessee  37072
Dermatology Associates of Knoxville, PC Knoxville, Tennessee  37922
Arlington Center for Dermatology Arlington, Texas  76011
Lone Star Children's Medical PLLC Houston, Texas  77092
Dermatology and Laser Center Irving, Texas  75061
Lubbock Dermatology and Skin Cancer Center Lubbock, Texas  79410
Shelby Dermatology Albaster, Alabama  35007
Pediatric Care Center of NE Alabama Anniston, Alabama  36207
Pediatric & Adult Asthma and Allergy, P.C. Birmingham, Alabama  35209
Metro Pediatrics, P.C Birmingham, Alabama  35209
Southview Dermatology Birmingham, Alabama  35213
Derma Phoenix, Arizona  85048
Alliance Dermatology Phoenix, Arizona  85032
Hull Dermatology, P.A. Rogers, Arkansas  72758
Coastal Allergy Care Camarillo, California  93010
Tien Nguyen Garden Grove, California  92843
Dermatology Research Associates Los Angeles, California  90045
Capital Allergy & Respiratory Disease Center Sacramento, California  95819
Allergy and Immunology Clinic San Diego, California  92111
Connecticut Children's Medical Center Dept of Dermatology Hartford, Connecticut  06106
Webster Dermatology, PA Hockessin, Delaware  19707
Atlantic Skin & Cosmetic Surgery Group Wilmington, Delaware  19810
Joshua Berlin P.A. Boynton Beach, Florida  33437
Angelos Koutsonikolis, MD, PA Boynton Beach, Florida  33437
Fort Lauderdale Dermatology & Cosmetic Skin Center Fort Lauderdale, Florida  33308
Tory Patrick Sullivan N. Miami Beach, Florida  33162
Andrea Trowers, MD North Miami, Florida  33181
Allergy Associates of the Palm Beaches, PA North Palm Beach, Florida  33408
Orlando Dermatology Orlando, Florida  32819
Donna Zeide Palm Beach Gardens, Florida  33418
Dr.Robert A. Norman Tampa, Florida  33626
Academic Alliance in Dermatology Tampa, Florida  33615
Georgia Pollens Clinical Research Centers, Inc Albany, Georgia  31707
Dermatology Consultants PC Covington, Georgia  30014
MedaPhase,Inc. Newnan, Georgia  30263
AeroAllergy Research Labs of Savannah, Inc. Savannah, Georgia  31406
Southern Crescent Dermatology Stockbridge, Georgia  30281
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
Dermatology, Inc. Carmel, Indiana  46032
The Dermatology Center New Albany, Indiana  47150
Dermatology Center of Indiana P.C. Plainfield, Indiana  46168
Clinton Urgent Care Clinton, Iowa  52732
Midwest Dermatology Overland Park, Kansas  66209
Mid-Kansas Dermatology Clinic, PA Wichita, Kansas  67206
Michael W. Simon, M.D. Nicholasville, Kentucky  40356
Kids First Prytania New Orleans, Louisiana  70115
All Kids Pediatrics of Opelousas APMC Opelousas, Louisiana  70570
Holliway Pediatric Clinic Shreveport, Louisiana  71103
Healing Hands Family Medicine Shreveport, Louisiana  71129
Wee Care Pediatrics & Kidmed Clinic Shreveport, Louisiana  71107
Johns Hopkins University, Division of Pediatric Dermatolgy Baltimore, Maryland  21287
Clarksburg Pediatrics, LLC Clarksburg, Maryland  20871
Family Allergy & Asthma Care Gaithersburg, Maryland  20878
DermAssociates, PC Silver Spring, Maryland  20902
Robert S. Berger White Plains, Maryland  20695
Boston Children's Hospital Boston, Massachusetts  02115
Adult & Pediatric Dermatology Marlborough, Massachusetts  01752
Hamzavi Dermatology Fort Gratiot, Michigan  48059
Silverton Skin Institute Grand Blanc, Michigan  48439
SVC Dermatology PC Sterling Heights, Michigan  48314
Grekin Skin Institute Warren, Michigan  48093
Dermatology Center for Children and Young Adults Eagan, Minnesota  55121
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
Advanced Skin Research Omaha, Nebraska  68144
Bettencourt Skin Center Henderson, Nevada  89014
Aistheta Reno, Nevada  89509
Cheryl D. Ackerman Glen Ridge, New Jersey  07028
CDLC Ridgewood, New Jersey  07450
The Dermatology Group, PC Verona, New Jersey  07044
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
Hollis Medisys Hollis, New York  11432
Marvin S.Watsky Lindenhurst, New York  11757
Columbia University Medical Center., Dept. of Medicine New York, New York  10032
Helendale Dermatology & Medical Spa, LLC Rochester, New York  14609
Derm Research Center of New York, Inc. Stony Brook, New York  11790
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
Knox Clinic Pediatrics, PLLC Wilmington, North Carolina  28403
Carolina Dermatology & Skin Cancer Surgery Wilmington, North Carolina  28403
Dermatology Research Associates, Inc. Cincinnati, Ohio  45230
Haber Dermatology and Cosmetic Surgery, Inc South Euclid, Ohio  44118
Warren Dermatology & Allergy Warren, Ohio  44484
Brian Lepley, D.O. Oklahoma City, Oklahoma  73139
College of Osteopathic Med Tulsa, Oklahoma  74127
Philadelphia Institute of Dermatology Fort Washington, Pennsylvania  19034
National Allergy, Asthma & Urticaria Centers of Charleston, PA Charleston, South Carolina  29406
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
Allergic Disease & Asthma Center Greenville, South Carolina  29406
Palmetto Skin & Laser Center Rock Hill, South Carolina  29732
The Asthma Institute PLLC Chattanooga, Tennessee  37421
Allergy Associates, PA dba East Tennessee Center for Clinical Research Knoxville, Tennessee  37909
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  76011
Zoltan Trizna Austin, Texas  78759
Pediatric Allergy/Immunology Associates Dallas, Texas  75230
Dermatology Treatment and Research Center, PA Dallas, Texas  75230
Pushpa R. Rana M.D. P.A. Dallas, Texas  75217
Western Sky Medical Research El Paso, Texas  79903
North Texas Institute for Clinical Trials Fort Worth, Texas  76132
University of N. Texas Health Science Center Fort Worth, Texas  76107
Dermatology Center of Frisco Frisco, Texas  75035
Pediatric Dermatology of North Texas PA Grapevine, Texas  76051
Stephen Schwartz Harlingen, Texas  78550
Bear Creek Clinic, PA Houston, Texas  77084
Heights Dermatology & Aesthetic Center Houston, Texas  77008
Rick Lin, D.O., MPH McAllen, Texas  78504
Pasadena Dermatology Clinic Pasadena, Texas  77506
Medical Research Network Spring, Texas  77373
Trinity Clinic, Pediatrics Tyler, Texas  75702
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
Asthma, Inc. Seattle, Washington  98105
Univeristy of Wisconsin-Madison Madison, Wisconsin  53792
George V. Chandy MD SC Milwaukee, Wisconsin  53208
Central Wyoming Skin Clinic Casper, Wyoming  82609
California Dermatology Care San Ramon, California  94583
Shideler Clinical Research Center Carmel, Indiana  46032
Beverly Johnson, MD Silver Springs, Maryland  20904