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


N/A
N/A
16 Years
Open (Enrolling)
Both
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
study.


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:

Observational

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:

No

Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

F506-CL-5801

NCT ID:

NCT00475605

Start Date:

May 2005

Completion Date:

August 2022

Related Keywords:

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

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
University of MinnesotaMinneapolis, Minnesota  55455
Emory UniversityAtlanta, Georgia  30322
Children's Memorial HospitalChicago, Illinois  60614
University of New MexicoAlbuquerque, New Mexico  87131
Oklahoma University Health Sciences CenterOklahoma City, Oklahoma  73104
Yale University School Of MedicineNew Haven, Connecticut  06520
Wake Forest University School of MedicineWinston-Salem, North Carolina  27157-1023
Highland ClinicShreveport, Louisiana  71105
North Florida Dermatology Associates, P.A.Jacksonville, Florida  32204
Henry Ford Medical CenterDearborn, Michigan  48126
Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Total Skin and Beauty Dermatology CenterBirmingham, Alabama  35205
Christie ClinicChampaign, Illinois  61820
Dawes Fretzin Clinical Research Group, LLCIndianapolis, Indiana  46256
Dermatology Associates, PCIndianapolis, Indiana  46240
Kansas City Dermatology, PAOverland Park, Kansas  66215
Callender Skin and Laser CenterMitchellville, Maryland  20721
Somerset Skin CentreTroy, Michigan  48084
University Dermatology Consultants, Inc.Cincinnati, Ohio  45242
Clinical Partners, LLCJohnston, Rhode Island  02919
Dermatology Associates of Kingsport, PCKingsport, Tennessee  37660
West Houston Dermatology, PAHouston, Texas  77082
Eastern Washington DermatologyDayton, Washington  99328
Dermatology Associates, PLLCSeattle, Washington  98101
Melissa KnucklesCorbin, Kentucky  40701
University Of Miami Miller School Of MedicineMiami, Florida  33010
Virginia Clinical Research, Inc.Norfolk, Virginia  23507
Children's Hospital of the Kings DaughtersNorfolk, Virginia  23507
St. Luke's Roosevelt Hospital CenterNew York, New York  10019
Rady Children's Hospital San DiegoSan Diego, California  92123
University of Texas - HoustonHouston, Texas  77030
Ruth A YatesHuntsville, Alabama  35801
California Skin InstituteMountain View, California  94040
Center for DermatologyBoca Raton, Florida  33428
Dermatologic Surgery Specialist Inc.Macon, Georgia  31217
Paul S. Takiguchi- MD- Inc.Aiea, Hawaii  96701
Randall DermatologyWest Lafayette, Indiana  47906
Kansas Medical Clinic, PATopeka, Kansas  66614
LA Dermatology Assoc LLCBaton Rouge, Louisiana  70809
Dimitri DermatologyGretna, Louisiana  70056
Kenneth M. Reed, MDQuincy, Massachusetts  02169
Drs. Iacobelli & DiGregorio, PCClinton Township, Michigan  48038
Midwest Center for Dermatology and Cosmetic SurgeryWarren, Michigan  48093
Garden City Dermatology, P.C.Garden City, New York  11530
Orange Dermatology Assoc, PCMonroe, New York  10950
Marina I Peredo, MDSmithtown, New York  11787
Joseph D. Sutton, MDSuffern, New York  10901
Stanley A. NewfieldValley Stream, New York  11581
Davie DermatologyAdvance, North Carolina  27006
Atlantic Dermatology Associates, P.A.Wilmington, North Carolina  28401
East Penn DermatologyNorth Wales, Pennsylvania  19454
Paddington Testing Co, Inc.Philadelphia, Pennsylvania  19103
McClerklin Skin and Laser CenterColumbia, South Carolina  29203
Rivergate Dermatology Research CenterGoodlettsville, Tennessee  37072
Dermatology Associates of Knoxville, PCKnoxville, Tennessee  37922
Arlington Center for DermatologyArlington, Texas  76011
Lone Star Children's Medical PLLCHouston, Texas  77092
Dermatology and Laser CenterIrving, Texas  75061
Lubbock Dermatology and Skin Cancer CenterLubbock, Texas  79410
Shelby DermatologyAlbaster, Alabama  35007
Pediatric Care Center of NE AlabamaAnniston, Alabama  36207
Pediatric & Adult Asthma and Allergy, P.C.Birmingham, Alabama  35209
Metro Pediatrics, P.CBirmingham, Alabama  35209
Southview DermatologyBirmingham, Alabama  35213
DermaPhoenix, Arizona  85048
Alliance DermatologyPhoenix, Arizona  85032
Hull Dermatology, P.A.Rogers, Arkansas  72758
Coastal Allergy CareCamarillo, California  93010
Tien NguyenGarden Grove, California  92843
Dermatology Research AssociatesLos Angeles, California  90045
Capital Allergy & Respiratory Disease CenterSacramento, California  95819
Allergy and Immunology ClinicSan Diego, California  92111
Connecticut Children's Medical Center Dept of DermatologyHartford, Connecticut  06106
Webster Dermatology, PAHockessin, Delaware  19707
Atlantic Skin & Cosmetic Surgery GroupWilmington, Delaware  19810
Joshua Berlin P.A.Boynton Beach, Florida  33437
Angelos Koutsonikolis, MD, PABoynton Beach, Florida  33437
Fort Lauderdale Dermatology & Cosmetic Skin CenterFort Lauderdale, Florida  33308
Tory Patrick SullivanN. Miami Beach, Florida  33162
Andrea Trowers, MDNorth Miami, Florida  33181
Allergy Associates of the Palm Beaches, PANorth Palm Beach, Florida  33408
Orlando DermatologyOrlando, Florida  32819
Donna ZeidePalm Beach Gardens, Florida  33418
Dr.Robert A. NormanTampa, Florida  33626
Academic Alliance in DermatologyTampa, Florida  33615
Georgia Pollens Clinical Research Centers, IncAlbany, Georgia  31707
Dermatology Consultants PCCovington, Georgia  30014
MedaPhase,Inc.Newnan, Georgia  30263
AeroAllergy Research Labs of Savannah, Inc.Savannah, Georgia  31406
Southern Crescent DermatologyStockbridge, Georgia  30281
Wayne Fujita, M.D. - Private PracticeAiea, Hawaii  96701
Dermatology Clinic of IdahoBoise, Idaho  83704
Southeast Idaho Family PracticeIdaho Falls, Idaho  83404
DermAssociates LTDBelleville, Illinois  62226
Dermatology, Inc.Carmel, Indiana  46032
The Dermatology CenterNew Albany, Indiana  47150
Dermatology Center of Indiana P.C.Plainfield, Indiana  46168
Clinton Urgent CareClinton, Iowa  52732
Midwest DermatologyOverland Park, Kansas  66209
Mid-Kansas Dermatology Clinic, PAWichita, Kansas  67206
Michael W. Simon, M.D.Nicholasville, Kentucky  40356
Kids First PrytaniaNew Orleans, Louisiana  70115
All Kids Pediatrics of Opelousas APMCOpelousas, Louisiana  70570
Holliway Pediatric ClinicShreveport, Louisiana  71103
Healing Hands Family MedicineShreveport, Louisiana  71129
Wee Care Pediatrics & Kidmed ClinicShreveport, Louisiana  71107
Johns Hopkins University, Division of Pediatric DermatolgyBaltimore, Maryland  21287
Clarksburg Pediatrics, LLCClarksburg, Maryland  20871
Family Allergy & Asthma CareGaithersburg, Maryland  20878
DermAssociates, PCSilver Spring, Maryland  20902
Robert S. BergerWhite Plains, Maryland  20695
Boston Children's HospitalBoston, Massachusetts  02115
Adult & Pediatric DermatologyMarlborough, Massachusetts  01752
Hamzavi DermatologyFort Gratiot, Michigan  48059
Silverton Skin InstituteGrand Blanc, Michigan  48439
SVC Dermatology PCSterling Heights, Michigan  48314
Grekin Skin InstituteWarren, Michigan  48093
Dermatology Center for Children and Young AdultsEagan, Minnesota  55121
Asthma & Allergy Center of North JacksonJackson, Mississippi  39206
Peace Children's ClinicJackson, Mississippi  39216
North County DermatologyFlorissant, Missouri  63031
Kosse PediatricsSaint Joseph, Missouri  64506
South Lincoln Dermatology ClinicLincoln, Nebraska  68502
Advanced Skin ResearchOmaha, Nebraska  68144
Bettencourt Skin CenterHenderson, Nevada  89014
AisthetaReno, Nevada  89509
Cheryl D. AckermanGlen Ridge, New Jersey  07028
CDLCRidgewood, New Jersey  07450
The Dermatology Group, PCVerona, New Jersey  07044
Allergy & Asthma Associates of NNMLos Alamos, New Mexico  87544
New York Dermatology, P.C.Bayside, New York  11360
Robert S. Darr, MD, PCBrooklyn, New York  11209
Morris Westfried, M.D.Brooklyn, New York  11228
Hollis MedisysHollis, New York  11432
Marvin S.WatskyLindenhurst, New York  11757
Columbia University Medical Center., Dept. of MedicineNew York, New York  10032
Helendale Dermatology & Medical Spa, LLCRochester, New York  14609
Derm Research Center of New York, Inc.Stony Brook, New York  11790
Alamance Skin CenterBurlington, North Carolina  27215
Pediatrx ClinicFayetteville, North Carolina  28305
Southeastern Dermatology, PALumberton, North Carolina  28358
FMC/OICRocky Mount, North Carolina  27801
Knox Clinic Pediatrics, PLLCWilmington, North Carolina  28403
Carolina Dermatology & Skin Cancer SurgeryWilmington, North Carolina  28403
Dermatology Research Associates, Inc.Cincinnati, Ohio  45230
Haber Dermatology and Cosmetic Surgery, IncSouth Euclid, Ohio  44118
Warren Dermatology & AllergyWarren, Ohio  44484
Brian Lepley, D.O.Oklahoma City, Oklahoma  73139
College of Osteopathic MedTulsa, Oklahoma  74127
Philadelphia Institute of DermatologyFort Washington, Pennsylvania  19034
National Allergy, Asthma & Urticaria Centers of Charleston, PACharleston, South Carolina  29406
Dermatology and Laser Center of CharlestonCharleston, South Carolina  29414
Cheraw Pediatrics, P.A.Cheraw, South Carolina  29520
Dermatology Group LLCColumbia, South Carolina  29201
Allergic Disease & Asthma CenterGreenville, South Carolina  29406
Palmetto Skin & Laser CenterRock Hill, South Carolina  29732
The Asthma Institute PLLCChattanooga, Tennessee  37421
Allergy Associates, PA dba East Tennessee Center for Clinical ResearchKnoxville, Tennessee  37909
The Skin Wellness CenterKnoxville, Tennessee  37922
Sheffield Pediatrics, PLLCMemphis, Tennessee  38104
Raleigh Group PCMemphis, Tennessee  38128
Academy of Clinical ResearchArlington, Texas  76011
Zoltan TriznaAustin, Texas  78759
Pediatric Allergy/Immunology AssociatesDallas, Texas  75230
Dermatology Treatment and Research Center, PADallas, Texas  75230
Pushpa R. Rana M.D. P.A.Dallas, Texas  75217
Western Sky Medical ResearchEl Paso, Texas  79903
North Texas Institute for Clinical TrialsFort Worth, Texas  76132
University of N. Texas Health Science CenterFort Worth, Texas  76107
Dermatology Center of FriscoFrisco, Texas  75035
Pediatric Dermatology of North Texas PAGrapevine, Texas  76051
Stephen SchwartzHarlingen, Texas  78550
Bear Creek Clinic, PAHouston, Texas  77084
Heights Dermatology & Aesthetic CenterHouston, Texas  77008
Rick Lin, D.O., MPHMcAllen, Texas  78504
Pasadena Dermatology ClinicPasadena, Texas  77506
Medical Research NetworkSpring, Texas  77373
Trinity Clinic, PediatricsTyler, Texas  75702
Dermatology Research CenterSalt Lake City, Utah  84117
Brookside PediatricsBennington, Vermont  05201
Glenn H. Fuchs, MD PCArlington, Virginia  22204
Dermatology Assoc of Northern VinelandCentreville, Virginia  20121
Piedmont Dermatology Center, PCMartinsville, Virginia  24112
Asthma, Inc.Seattle, Washington  98105
Univeristy of Wisconsin-MadisonMadison, Wisconsin  53792
George V. Chandy MD SCMilwaukee, Wisconsin  53208
Central Wyoming Skin ClinicCasper, Wyoming  82609
California Dermatology CareSan Ramon, California  94583
Shideler Clinical Research CenterCarmel, Indiana  46032
Beverly Johnson, MDSilver Springs, Maryland  20904