A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis (APPLES)
This study is ongoing, but not recruiting participants.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00475605
First received: May 17, 2007
Last updated: May 17, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Atopic Dermatitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- The endpoint is the occurrence of serious adverse events, including the observation of systemic and cutaneous malignancies [ Time Frame: At six month intervals for ten years ] [ Designated as safety issue: No ]
| Enrollment: | 8037 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | August 2022 |
| Estimated Primary Completion Date: | August 2022 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1. Protopic Exposure
Pediatric subjects whose ages are/were <16 years at the time of first tacrolimus ointment exposure
|
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.
Eligibility| Ages Eligible for Study: | up to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Pediatric subjects whose ages are/were <16 years at the time of first tacrolimus ointment exposure
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475605
Hide Study Locations
Hide Study LocationsLocations
| United States, Alabama | |
| Shelby Dermatology | |
| Albaster, Alabama, United States, 35007 | |
| Pediatric Care Center of NE Alabama | |
| Anniston, Alabama, United States, 36207 | |
| Total Skin and Beauty Dermatology Center | |
| Birmingham, Alabama, United States, 35205 | |
| Metro Pediatrics, P.C | |
| Birmingham, Alabama, United States, 35209 | |
| Pediatric & Adult Asthma and Allergy, P.C. | |
| Birmingham, Alabama, United States, 35209 | |
| Southview Dermatology | |
| Birmingham, Alabama, United States, 35213 | |
| Ruth A Yates | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Derma | |
| Phoenix, Arizona, United States, 85048 | |
| Alliance Dermatology | |
| Phoenix, Arizona, United States, 85032 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| Hull Dermatology, P.A. | |
| Rogers, Arkansas, United States, 72758 | |
| United States, California | |
| Coastal Allergy Care | |
| Camarillo, California, United States, 93010 | |
| Tien Nguyen | |
| Garden Grove, California, United States, 92843 | |
| Dermatology Research Associates | |
| Los Angeles, California, United States, 90045 | |
| California Skin Institute | |
| Mountain View, California, United States, 94040 | |
| Capital Allergy & Respiratory Disease Center | |
| Sacramento, California, United States, 95819 | |
| Allergy and Immunology Clinic | |
| San Diego, California, United States, 92111 | |
| Rady Children's Hospital San Diego | |
| San Diego, California, United States, 92123 | |
| California Dermatology Care | |
| San Ramon, California, United States, 94583 | |
| United States, Connecticut | |
| Connecticut Children's Medical Center Dept of Dermatology | |
| Hartford, Connecticut, United States, 06106 | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06519 | |
| United States, Delaware | |
| Webster Dermatology, PA | |
| Hockessin, Delaware, United States, 19707 | |
| Atlantic Skin & Cosmetic Surgery Group | |
| Wilmington, Delaware, United States, 19810 | |
| United States, Florida | |
| Center for Dermatology | |
| Boca Raton, Florida, United States, 33428 | |
| Joshua Berlin P.A. | |
| Boynton Beach, Florida, United States, 33437 | |
| Angelos Koutsonikolis, MD, PA | |
| Boynton Beach, Florida, United States, 33437 | |
| Fort Lauderdale Dermatology & Cosmetic Skin Center | |
| Fort Lauderdale, Florida, United States, 33308 | |
| North Florida Dermatology Associates, P.A. | |
| Jacksonville, Florida, United States, 32204 | |
| University of Miami Miller School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Tory Patrick Sullivan | |
| N. Miami Beach, Florida, United States, 33162 | |
| Andrea Trowers, MD | |
| North Miami, Florida, United States, 33181 | |
| Allergy Associates of the Palm Beaches, PA | |
| North Palm Beach, Florida, United States, 33408 | |
| Orlando Dermatology | |
| Orlando, Florida, United States, 32819 | |
| Donna Zeide | |
| Palm Beach Gardens, Florida, United States, 33418 | |
| Dr.Robert A. Norman | |
| Tampa, Florida, United States, 33626 | |
| Academic Alliance in Dermatology | |
| Tampa, Florida, United States, 33615 | |
| United States, Georgia | |
| Georgia Pollens Clinical Research Centers, Inc | |
| Albany, Georgia, United States, 31707 | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| Dermatology Consultants PC | |
| Covington, Georgia, United States, 30014 | |
| Dermatologic Surgery Specialist Inc. | |
| Macon, Georgia, United States, 31217 | |
| MedaPhase,Inc. | |
| Newnan, Georgia, United States, 30263 | |
| AeroAllergy Research Labs of Savannah, Inc. | |
| Savannah, Georgia, United States, 31406 | |
| Southern Crescent Dermatology | |
| Stockbridge, Georgia, United States, 30281 | |
| United States, Hawaii | |
| Wayne Fujita, M.D. - Private Practice | |
| Aiea, Hawaii, United States, 96701 | |
| Paul S. Takiguchi- MD- Inc. | |
| Aiea, Hawaii, United States, 96701 | |
| United States, Idaho | |
| Dermatology Clinic of Idaho | |
| Boise, Idaho, United States, 83704 | |
| Southeast Idaho Family Practice | |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Illinois | |
| DermAssociates LTD | |
| Belleville, Illinois, United States, 62226 | |
| Christie Clinic | |
| Champaign, Illinois, United States, 61820 | |
| Children's Memorial Hospital | |
| Chicago, Illinois, United States, 60614 | |
| United States, Indiana | |
| Dermatology, Inc. | |
| Carmel, Indiana, United States, 46032 | |
| Shideler Clinical Research Center | |
| Carmel, Indiana, United States, 46032 | |
| Dermatology Associates, PC | |
| Indianapolis, Indiana, United States, 46240 | |
| Dawes Fretzin Clinical Research Group, LLC | |
| Indianapolis, Indiana, United States, 46256 | |
| The Dermatology Center | |
| New Albany, Indiana, United States, 47150 | |
| Dermatology Center of Indiana P.C. | |
| Plainfield, Indiana, United States, 46168 | |
| Randall Dermatology | |
| West Lafayette, Indiana, United States, 47906 | |
| United States, Iowa | |
| Clinton Urgent Care | |
| Clinton, Iowa, United States, 52732 | |
| United States, Kansas | |
| Kansas City Dermatology, PA | |
| Overland Park, Kansas, United States, 66215 | |
| Midwest Dermatology | |
| Overland Park, Kansas, United States, 66209 | |
| Kansas Medical Clinic, PA | |
| Topeka, Kansas, United States, 66614 | |
| Mid-Kansas Dermatology Clinic, PA | |
| Wichita, Kansas, United States, 67206 | |
| United States, Kentucky | |
| Melissa Knuckles | |
| Corbin, Kentucky, United States, 40701 | |
| Lexington, Kentucky, United States, 40503 | |
| Michael W. Simon, M.D. | |
| Nicholasville, Kentucky, United States, 40356 | |
| United States, Louisiana | |
| LA Dermatology Assoc LLC | |
| Baton Rouge, Louisiana, United States, 70809 | |
| Dimitri Dermatology | |
| Gretna, Louisiana, United States, 70056 | |
| Kids First Prytania | |
| New Orleans, Louisiana, United States, 70115 | |
| All Kids Pediatrics of Opelousas APMC | |
| Opelousas, Louisiana, United States, 70570 | |
| Highland Clinic | |
| Shreveport, Louisiana, United States, 71105 | |
| Holliway Pediatric Clinic | |
| Shreveport, Louisiana, United States, 71103 | |
| Healing Hands Family Medicine | |
| Shreveport, Louisiana, United States, 71129 | |
| Wee Care Pediatrics & Kidmed Clinic | |
| Shreveport, Louisiana, United States, 71107 | |
| United States, Maryland | |
| Johns Hopkins University, Division of Pediatric Dermatolgy | |
| Baltimore, Maryland, United States, 21287 | |
| Clarksburg Pediatrics, LLC | |
| Clarksburg, Maryland, United States, 20871 | |
| Family Allergy & Asthma Care | |
| Gaithersburg, Maryland, United States, 20878 | |
| Callender Skin and Laser Center | |
| Glenn Dale, Maryland, United States, 20769 | |
| DermAssociates, PC | |
| Silver Spring, Maryland, United States, 20902 | |
| Beverly Johnson, MD | |
| Silver Springs, Maryland, United States, 20904 | |
| Robert S. Berger | |
| White Plains, Maryland, United States, 20695 | |
| United States, Massachusetts | |
| Boston Children's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Adult & Pediatric Dermatology | |
| Marlborough, Massachusetts, United States, 01752 | |
| Kenneth M. Reed, MD | |
| Quincy, Massachusetts, United States, 02169 | |
| United States, Michigan | |
| Drs. Iacobelli & DiGregorio, PC | |
| Clinton Township, Michigan, United States, 48038 | |
| Henry Ford Medical Center | |
| Detroit, Michigan, United States, 48202 | |
| Hamzavi Dermatology | |
| Fort Gratiot, Michigan, United States, 48059 | |
| Silverton Skin Institute | |
| Grand Blanc, Michigan, United States, 48439 | |
| SVC Dermatology PC | |
| Sterling Heights, Michigan, United States, 48314 | |
| Somerset Skin Centre | |
| Troy, Michigan, United States, 48084 | |
| Grekin Skin Institute | |
| Warren, Michigan, United States, 48093 | |
| Midwest Center for Dermatology and Cosmetic Surgery | |
| Warren, Michigan, United States, 48093 | |
| United States, Minnesota | |
| Dermatology Center for Children and Young Adults | |
| Eagan, Minnesota, United States, 55121 | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Mississippi | |
| Asthma & Allergy Center of North Jackson | |
| Jackson, Mississippi, United States, 39206 | |
| Peace Children's Clinic | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| North County Dermatology | |
| Florissant, Missouri, United States, 63031 | |
| Kosse Pediatrics | |
| Saint Joseph, Missouri, United States, 64506 | |
| United States, Nebraska | |
| South Lincoln Dermatology Clinic | |
| Lincoln, Nebraska, United States, 68502 | |
| Advanced Skin Research | |
| Omaha, Nebraska, United States, 68144 | |
| United States, Nevada | |
| Bettencourt Skin Center | |
| Henderson, Nevada, United States, 89014 | |
| Aistheta | |
| Reno, Nevada, United States, 89509 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Cheryl D. Ackerman | |
| Glen Ridge, New Jersey, United States, 07028 | |
| CDLC | |
| Ridgewood, New Jersey, United States, 07450 | |
| The Dermatology Group, PC | |
| Verona, New Jersey, United States, 07044 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| Allergy & Asthma Associates of NNM | |
| Los Alamos, New Mexico, United States, 87544 | |
| United States, New York | |
| New York Dermatology, P.C. | |
| Bayside, New York, United States, 11360 | |
| Robert S. Darr, MD, PC | |
| Brooklyn, New York, United States, 11209 | |
| Morris Westfried, M.D. | |
| Brooklyn, New York, United States, 11228 | |
| Garden City Dermatology, P.C. | |
| Garden City, New York, United States, 11530 | |
| Hollis Medisys | |
| Hollis, New York, United States, 11432 | |
| Marvin S.Watsky | |
| Lindenhurst, New York, United States, 11757 | |
| Orange Dermatology Assoc, PC | |
| Monroe, New York, United States, 10950 | |
| Columbia University Medical Center., Dept. of Medicine | |
| New York, New York, United States, 10032 | |
| St. Luke's Roosevelt Hospital Center | |
| New York, New York, United States, 10025 | |
| Helendale Dermatology & Medical Spa, LLC | |
| Rochester, New York, United States, 14609 | |
| Marina I Peredo, MD | |
| Smithtown, New York, United States, 11787 | |
| Derm Research Center of New York, Inc. | |
| Stony Brook, New York, United States, 11790 | |
| Joseph D. Sutton, MD | |
| Suffern, New York, United States, 10901 | |
| Stanley A. Newfield | |
| Valley Stream, New York, United States, 11581 | |
| United States, North Carolina | |
| Davie Dermatology | |
| Advance, North Carolina, United States, 27006 | |
| Pediatrx Clinic | |
| Fayetteville, North Carolina, United States, 28305 | |
| Southeastern Dermatology, PA | |
| Lumberton, North Carolina, United States, 28358 | |
| FMC/OIC | |
| Rocky Mount, North Carolina, United States, 27801 | |
| Atlantic Dermatology Associates, P.A. | |
| Wilmington, North Carolina, United States, 28401 | |
| Carolina Dermatology & Skin Cancer Surgery | |
| Wilmington, North Carolina, United States, 28403 | |
| Knox Clinic Pediatrics, PLLC | |
| Wilmington, North Carolina, United States, 28403 | |
| Wake Forest University School of Medicine | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Dermatology Research Associates, Inc. | |
| Cincinnati, Ohio, United States, 45230 | |
| University Dermatology Consultants, Inc. | |
| Cincinnati, Ohio, United States, 45219 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Haber Dermatology and Cosmetic Surgery, Inc | |
| South Euclid, Ohio, United States, 44118 | |
| Warren Dermatology & Allergy | |
| Warren, Ohio, United States, 44484 | |
| United States, Oklahoma | |
| Brian Lepley, D.O. | |
| Oklahoma City, Oklahoma, United States, 73139 | |
| Oklahoma University Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| College of Osteopathic Med | |
| Tulsa, Oklahoma, United States, 74127 | |
| United States, Pennsylvania | |
| Philadelphia Institute of Dermatology | |
| Fort Washington, Pennsylvania, United States, 19034 | |
| Penn State Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| East Penn Dermatology | |
| North Wales, Pennsylvania, United States, 19454 | |
| Paddington Testing Co, Inc. | |
| Philadelphia, Pennsylvania, United States, 19103 | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| Clinical Partners, LLC | |
| Johnston, Rhode Island, United States, 02919 | |
| United States, South Carolina | |
| National Allergy, Asthma & Urticaria Centers of Charleston, PA | |
| Charleston, South Carolina, United States, 29406 | |
| Dermatology and Laser Center of Charleston | |
| Charleston, South Carolina, United States, 29414 | |
| Cheraw Pediatrics, P.A. | |
| Cheraw, South Carolina, United States, 29520 | |
| Dermatology Group LLC | |
| Columbia, South Carolina, United States, 29201 | |
| McClerklin Skin and Laser Center | |
| Columbia, South Carolina, United States, 29203 | |
| Allergic Disease & Asthma Center | |
| Greenville, South Carolina, United States, 29406 | |
| Palmetto Skin & Laser Center | |
| Rock Hill, South Carolina, United States, 29732 | |
| United States, Tennessee | |
| The Asthma Institute PLLC | |
| Chattanooga, Tennessee, United States, 37421 | |
| Rivergate Dermatology Research Center | |
| Goodlettsville, Tennessee, United States, 37072 | |
| Dermatology Associates of Kingsport, PC | |
| Kingsport, Tennessee, United States, 37660 | |
| Dermatology Associates of Knoxville, PC | |
| Knoxville, Tennessee, United States, 37917 | |
| Allergy Associates, PA dba East Tennessee Center for Clinical Research | |
| Knoxville, Tennessee, United States, 37909 | |
| The Skin Wellness Center | |
| Knoxville, Tennessee, United States, 37922 | |
| Sheffield Pediatrics, PLLC | |
| Memphis, Tennessee, United States, 38104 | |
| Raleigh Group PC | |
| Memphis, Tennessee, United States, 38128 | |
| United States, Texas | |
| Arlington Center for Dermatology | |
| Arlington, Texas, United States, 76011 | |
| Academy of Clinical Research | |
| Arlington, Texas, United States, 76011 | |
| Zoltan Trizna | |
| Austin, Texas, United States, 78759 | |
| Pediatric Allergy/Immunology Associates | |
| Dallas, Texas, United States, 75230 | |
| Pushpa R. Rana M.D. P.A. | |
| Dallas, Texas, United States, 75217 | |
| Dermatology Treatment and Research Center, PA | |
| Dallas, Texas, United States, 75230 | |
| Western Sky Medical Research | |
| El Paso, Texas, United States, 79903 | |
| North Texas Institute for Clinical Trials | |
| Fort Worth, Texas, United States, 76132 | |
| University of N. Texas Health Science Center | |
| Fort Worth, Texas, United States, 76107 | |
| Dermatology Center of Frisco | |
| Frisco, Texas, United States, 75035 | |
| Pediatric Dermatology of North Texas PA | |
| Grapevine, Texas, United States, 76051 | |
| Stephen Schwartz | |
| Harlingen, Texas, United States, 78550 | |
| Bear Creek Clinic, PA | |
| Houston, Texas, United States, 77084 | |
| Lone Star Children's Medical PLLC | |
| Houston, Texas, United States, 77092 | |
| West Houston Dermatology, PA | |
| Houston, Texas, United States, 77082 | |
| University of Texas - Houston | |
| Houston, Texas, United States, 77030 | |
| Heights Dermatology & Aesthetic Center | |
| Houston, Texas, United States, 77008 | |
| Dermatology and Laser Center | |
| Irving, Texas, United States, 75061 | |
| Lubbock Dermatology and Skin Cancer Center | |
| Lubbock, Texas, United States, 79410 | |
| Rick Lin, D.O., MPH | |
| McAllen, Texas, United States, 78504 | |
| Pasadena Dermatology Clinic | |
| Pasadena, Texas, United States, 77506 | |
| Medical Research Network | |
| Spring, Texas, United States, 77373 | |
| Trinity Clinic, Pediatrics | |
| Tyler, Texas, United States, 75702 | |
| United States, Utah | |
| Dermatology Research Center | |
| Salt Lake City, Utah, United States, 84117 | |
| United States, Vermont | |
| Brookside Pediatrics | |
| Bennington, Vermont, United States, 05201 | |
| United States, Virginia | |
| Glenn H. Fuchs, MD PC | |
| Arlington, Virginia, United States, 22204 | |
| Dermatology Assoc of Northern Vineland | |
| Centreville, Virginia, United States, 20121 | |
| Piedmont Dermatology Center, PC | |
| Martinsville, Virginia, United States, 24112 | |
| Virginia Clinical Research, Inc. | |
| Norfolk, Virginia, United States, 23507 | |
| Children's Hospital of the Kings Daughters | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Dermatology Associates, PLLC | |
| Seattle, Washington, United States, 98101 | |
| Asthma, Inc. | |
| Seattle, Washington, United States, 98105 | |
| Eastern Washington Dermatology | |
| Walla Walla, Washington, United States, 99362 | |
| United States, Wisconsin | |
| Univeristy of Wisconsin-Madison | |
| Madison, Wisconsin, United States, 53792 | |
| George V. Chandy MD SC | |
| Milwaukee, Wisconsin, United States, 53208 | |
| United States, Wyoming | |
| Central Wyoming Skin Clinic | |
| Casper, Wyoming, United States, 82609 | |
| Austria | |
| LKH Feldkirch | |
| Feldkirch, Austria, 6807 | |
| Landesfrauen- und -kinderklinik | |
| Linz, Austria, 4020 | |
| Salzburger Landeskliniken | |
| Salzburg, Austria, 5020 | |
| Canada, Manitoba | |
| Winnipeg Clinic | |
| Winnipeg, Manitoba, Canada, R3C 0N2 | |
| Canada, Newfoundland and Labrador | |
| NewLab Clinical Research, Inc. | |
| St John's, Newfoundland and Labrador, Canada, A1C 2H5 | |
| Nexus Clinical Research | |
| St Johns, Newfoundland and Labrador, Canada, A1A 5E8 | |
| Canada, Nova Scotia | |
| Eastern Canada Cutaneous Research Association | |
| Halifax, Nova Scotia, Canada, B3H 1Z4 | |
| Canada, Ontario | |
| Mediprobe Research, Inc. | |
| London, Ontario, Canada, N5X 2P1 | |
| Lynderm Research, Inc. | |
| Markham, Ontario, Canada, L3P 1A8 | |
| Sudbury Skin Clinic | |
| Sudbury, Ontario, Canada, P3E 5M4 | |
| France | |
| Cabinet Medical | |
| Amiens, France, 80090 | |
| Hopital Pellegrin | |
| Bordeaux, France, 33000 | |
| Cabinet de Dermatologie - Boulogne | |
| Boulogne, France, 92100 | |
| Cabinet de Dermatologie - Boulogne-Sur-Mer | |
| Boulogne, France, 62200 | |
| Hopital Augustin Morvan | |
| Brest Cedex 2, France, 29609 | |
| Cabinet de dermatologie - Cannes | |
| Cannes, France, 06400 | |
| Hopital Trousseau | |
| Chambray Les Tours Cedex, France, 37171 | |
| Polyclinique du Cotentin | |
| Equeurdreville, France, 50120 | |
| Centre Hospitalier | |
| Le Mans Cedex, France, 72037 | |
| Hopital Claude Huriez | |
| Lille Cedex, France, 59037 | |
| Cabinet de Dermatologie - Martigues | |
| Martigues, France, 13500 | |
| Cabinet Dermatologie | |
| Nantes, France, 44100 | |
| Hopital de l'Hotel Dieu | |
| Nantes Cedex 1, France, 44093 | |
| Cabinet de Dermatologie | |
| Nice, France, 06000 | |
| Cabinet de Dermatologie - Paris | |
| Paris, France, 75007 | |
| Hospital Saint Louis | |
| Paris Cedex 10, France, 75475 | |
| Hospital Necker | |
| Paris Cedex 15, France, 75743 | |
| CHU La MILETRIE Service de Dermatologie | |
| Poitiers Cedex, France, 86021 | |
| HOPITAL CHARLES NICOLLE Service de Dermatologie | |
| Rouen Cedex, France, 76031 | |
| Hopital Nord | |
| St. Priest En Jarez Cedex, France, 42277 | |
| Cabinet de Dermatologie-Strasbourg | |
| Strasbourg, France, 67000 | |
| Cabinet de Dermatologie | |
| Thann, France, 68800 | |
| Hopital Larrey | |
| Toulouse Cedex 9, France, 31059 | |
| Centre Hospitalier Service de Dermatologie | |
| Troyes Cedex, France, 10003 | |
| Germany | |
| Licca Clinical Research Institute | |
| Augsburg, Germany, 86179 | |
| Herr Dr. med Lutz Bellingrath, Kinderheilkunde | |
| Bamberg, Germany, 96050 | |
| Garbe, Florian Hautartzt | |
| Berlin, Germany, 13597 | |
| Wildfeuer,Thomas | |
| Berlin, Germany, 13055 | |
| Charite - Universitaetsmedizin Berlin Klinik fuer Dermatologie, Venerologie u. Allergologie | |
| Berlin, Germany, 10117 | |
| Praxis Dr. Dirk Gröne | |
| Berlin, Germany, 14052 | |
| Klinik fuer Kinder u. Jugendmedizin der Ruhr Universitaet Bochum im St.-Josef-Hospital | |
| Bochum, Germany, 44791 | |
| Universitaet Bonn Klinik und Poliklinik fuer Dermatologie | |
| Bonn, Germany, 53105 | |
| Hermann, Hautarztpraxis | |
| Bremen, Germany, 28239 | |
| Schwichtenberg, Uwe | |
| Bremen, Germany, 28779 | |
| Dermatologisches Zentrum Buxtehude | |
| Buxtehude, Germany, 21614 | |
| Hautarztpraxis Pfennig | |
| Crimmitschau, Germany, 08451 | |
| Heidlas, Hautarzt | |
| Dessau, Germany, 06842 | |
| Gerlach, Beatrice | |
| Dresden, Germany, 01097 | |
| Arztpraxis fuer Hautkrankheiten | |
| Dresden, Germany, 01169 | |
| Klinik und Poliklinik für Dermatologie Unviversitätsklinikum Dresden | |
| Dresden, Germany, 01307 | |
| Hautklinik | |
| Duesseldorf, Germany, 40225 | |
| Heinrich-Heine-Universitaet Hautklinik | |
| Duesseldorf, Germany, 40225 | |
| Falker, Gernot | |
| Frankenberg, Germany, 35066 | |
| Universitaetsklinikum Klinische Forschung, Zentrum d. Dermatologie u. Venerologie | |
| Frankfurt, Germany, 60590 | |
| Derma-Study-Center-Friedrichshafen | |
| Friedrichshafen, Germany, 88045 | |
| Hautarztpraxis | |
| Gelnhausen, Germany, 63571 | |
| SRH Wald-Klinikum Gera GmbH | |
| Gera, Germany, 07548 | |
| Kath. Kinderkrankenhaus Wilhelmstift | |
| Hamburg, Germany, 22149 | |
| Klinische Forschung Hannover-Mitte GmbH | |
| Hannover, Germany, 30159 | |
| Brinkmann, Hautarztpraxis | |
| Herborn, Germany, 35745 | |
| Facharzt fuer Kinder-und Jugendmedizin | |
| Hueckeswagen, Germany, 42499 | |
| Hautarztpraxis Sempell | |
| Itzehoe, Germany, 25524 | |
| Klinikum der Fr.-Schiller-Universitaet | |
| Jena, Germany, 07743 | |
| Tagesklinik fuer Allergie und Hautkrankheiten | |
| Kiel, Germany, 24148 | |
| Christian-Albrechts-Universitaet zu Kiel | |
| Kiel, Germany, 24105 | |
| Klinik fuer Dermatologie, Venerologie u. Allergologie | |
| Leipzig, Germany, 04103 | |
| Kinderklinik und -poliklinik der Johannes-Gutenberg Universitaet Mainz | |
| Mainz, Germany, 55101 | |
| Universitaetsklinikum Giessen+ Marburg Dermatolgie und Allergologie | |
| Marburg, Germany, 35037 | |
| Praxis Dermatologie | |
| Marburg, Germany, 35037 | |
| Schulze, Ina | |
| Markkleeberg, Germany, 04416 | |
| Kinder- und Jugendaertzin | |
| Moenchengladbach, Germany, 41066 | |
| Ludwig - Maximilians Universitaet, Klinik u. Poliklinik fuer Dermatologie u. Allergologie | |
| Muenchen, Germany, 80337 | |
| Universitaetsklinikum Muenster, Klinik & Poliklinik Fuer Hautkrankheiten | |
| Muenster, Germany, 48149 | |
| Proinnovera GmbH | |
| Muenster, Germany, 48155 | |
| Fellner von Feldegg, Philip | |
| Muenster, Germany, 48163 | |
| Krausse, Torsten | |
| Riesa, Germany, 01589 | |
| Richter - Fachaerztin fuer Kinder- und Jugendmedizin | |
| Solingen, Germany, 42697 | |
| Termeer, Christian | |
| Stuttgart, Germany, 70499 | |
| Universitaets-Hautklinik Tuebingen | |
| Tuebingen, Germany, 72076 | |
| Marienhospital Wesel | |
| Wesel, Germany, 46483 | |
| Kinderarztpraxis | |
| Wesseling, Germany, 50389 | |
| Hautarzt | |
| Wusterwitz, Germany, 14789 | |
| Ireland | |
| South Infirmary | |
| Cork, Ireland | |
| The Park Clinic | |
| Dublin, Ireland, 18 | |
| Our Lady's Hospital for Sick Children | |
| Dublin, Ireland, 12 | |
| Netherlands | |
| Academisch Medisch Centrum | |
| Amsterdam, Netherlands, 1105 AZ | |
| Universitair Medisch Centrum Groningen | |
| Groningen, Netherlands, 9713 GZ | |
| Universitair Medisch Centrum St. Radboud | |
| Nijmegen, Netherlands, 6525 GA | |
| Poland | |
| Poradnia Alergologiczna Przychodni Przyszpitalnej Wojewodzkiego Szpitala Dzieciecego | |
| Bydgoszcz, Poland, 85-087 | |
| Prywatna Praktyka Lekarska "Alergomed" | |
| Bydgoszcz, Poland, 85-077 | |
| Szpital Dzieciecy Specjalistyczny Z.O.Z. nad Matka i Dzieckiem | |
| Gdansk-Oliwa, Poland, 80-308 | |
| SPZOZ Szpital Specjalistyczny im. S. Zeromskiego | |
| Krakow, Poland, 31-913 | |
| NZOZ Centrum Alergologii | |
| Lodz, Poland, 90-553 | |
| Dermoklinika | |
| Lodz, Poland, 90-436 | |
| Gabinet Lekarski | |
| Lodz, Poland, 92-202 | |
| Alergovita | |
| Lublin, Poland, 20-803 | |
| Praktyka Lekarska | |
| Plock, Poland, 09-400 | |
| Szpital im. J. Babinskiego | |
| Sierpc, Poland, 09-200 | |
| NZOZ Przychodnia Dermatologiczna DERMED s.c | |
| Torun, Poland, 87-100 | |
| United Kingdom | |
| Amersham Hospital, Department of Dermatology | |
| Amersham, United Kingdom, HP7 0JD | |
| Birmingham Children's Hospital | |
| Birmingham, United Kingdom, B4 6NH | |
| Royal Bolton Hospitals Trust | |
| Bolton, United Kingdom, BL4 0JR | |
| Addenbrooke's Hospital | |
| Cambridge, United Kingdom, CB2 2QQ | |
| Wales College of Medicine, Cardiff University, Heath Park | |
| Cardiff, United Kingdom, CF14 4XN | |
| Ninewells Hospital and Medical School | |
| Dundee, United Kingdom, DD1 9SY | |
| Royal Infirmary of Edinburgh | |
| Edinburgh, United Kingdom, EH3 9YW | |
| Harrogate & District Foundation NHS Trust Hospital | |
| Harrogate, United Kingdom, HG2 7SX | |
| Leeds General Infirmary, Dept of Dermatology | |
| Leeds, United Kingdom, LS1 3EX | |
| Royal Free Hospital | |
| London, United Kingdom, NW3 2QG | |
| Univerisy of Manchester, Booth Hall Children's Hospital | |
| Manchester, United Kingdom, M97 AA | |
| Chase Farm Hospital | |
| Middlesex, United Kingdom, EN2 8JL | |
| George Eliot Hospital | |
| Nuneaton, United Kingdom, CV10 7DJ | |
| University of Manchester, Dermatology-Pharmacology Unit Hope Hospital | |
| Salford, United Kingdom, M6 8HD | |
| Salford, United Kingdom, M6 8HD | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Medical Director | Astellas Pharma Global Development |
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00475605 History of Changes |
| Other Study ID Numbers: | F506-CL-5801, FG506-06-37, 03-0-161 |
| Study First Received: | May 17, 2007 |
| Last Updated: | May 17, 2013 |
| Health Authority: | United States: Food and Drug Administration European Union: European Medicines Agency Canada: Health Canada |
Keywords provided by Astellas Pharma Inc:
|
Protopic Ointment tacrolimus ointment atopic dermatitis child |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Tacrolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013