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
N/A
16 Years
Open (Enrolling)
Both
Atopic Dermatitis
Both
Atopic Dermatitis
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 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 |
