Observational Evaluation of Atopic Dermatitis in Pediatric Patients
Study Purpose
Primary Objectives:
- - To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable.
- - To evaluate the time-course of AD and selected atopic comorbidities.
- - To characterize disease burden and unmet need.
- - To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching).
- - To document the real-world effectiveness and safety of treatments.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational [Patient Registry] |
Eligible Ages | 0 Years - 11 Years |
Gender | All |
Inclusion criteria:
- - Patients with moderate to severe AD, according to the Investigator's assessment; - Currently receiving systemic treatment (including phototherapy) for atopic dermatitis or currently on topical treatment, but otherwise candidates for systemic treatment.
Exclusion criteria:
- - Concurrent participation in an interventional clinical trial which modifies patient care.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03687359 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Sanofi |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Clinical Sciences & Operations |
Principal Investigator Affiliation | Sanofi |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Australia, Brazil, Canada, China, Colombia, Denmark, France, Greece, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Portugal, Russian Federation, Spain, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Dermatitis Atopic |
The study duration is 60 months.
Arms
: Participants with atopic dermatitis (AD)
Participants receive AD therapy as part of their usual care as determined by their physician independent of decision to enroll in the study.
Interventions
Other: - Standard of care
Treatment as per standard practice
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Completed
Address
Allervie Clinical Research Site Number : 8400012
Birmingham, Alabama, 35209
Status
Recruiting
Address
C Squared Research Center Site Number : 8400068
Birmingham, Alabama, 35209
Status
Recruiting
Address
Cahaba Dermatology Site Number : 8400046
Birmingham, Alabama, 35244
Status
Recruiting
Address
C2 Research Center, LLC Site Number : 8400071
Montgomery, Alabama, 36117
Status
Recruiting
Address
Phoenix Children's Hospital, Inc. Site Number : 8400015
Phoenix, Arizona, 85016
Status
Recruiting
Address
Orange County Research Institute Site Number : 8400028
Anaheim, California, 92801
Status
Recruiting
Address
Axis Clinical Trials Site Number : 8400025
Los Angeles, California, 90036
Status
Recruiting
Address
Madera Family Medical Group Site Number : 8400054
Madera, California, 93637
Status
Recruiting
Address
Carey Chronis, MD, FAAP Site Number : 8400033
Ventura, California, 93003
Status
Completed
Address
Immunoe Research Centers Site Number : 8400026
Centennial, Colorado, 80112
Status
Recruiting
Address
Daxia Trials Site Number : 8400082
Boca Raton, Florida, 33431
Status
Recruiting
Address
Pediatric Center Of Excellence Site Number : 8400072
Coral Gables, Florida, 33146
Status
Recruiting
Address
Green Dermatology and Cosmetic Center. Site Number : 8400078
Deerfield Beach, Florida, 33441
Status
Recruiting
Address
Amedica Research Institute, Inc. Site Number : 8400067
Hialeah, Florida, 33013
Status
Recruiting
Address
Eastern Research, Inc. Site Number : 8400032
Hialeah, Florida, 33013
Status
Recruiting
Address
Premier Dermatology Partners Site Number : 8400075
Miami, Florida, 33137
Status
Recruiting
Address
Ciocca, Giovanna Site Number : 8400018
Miami, Florida, 33173
Status
Recruiting
Address
Vista Health Research, LLC Site Number : 8400034
Miami, Florida, 33176
Status
Recruiting
Address
Pediatric & Adult Research Center Site Number : 8400040
Orlando, Florida, 32825
Status
Completed
Address
Georgia Pollens Clinical Research Centers, Inc. Site Number : 8400057
Albany, Georgia, 31707
Status
Recruiting
Address
Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400056
Columbus, Georgia, 31904
Status
Recruiting
Address
Northwestern University Feinberg School of Medicine Site Number : 8400001
Chicago, Illinois, 60611
Status
Recruiting
Address
NorthShore University HealthSystem Site Number : 8400064
Skokie, Illinois, 60077
Status
Recruiting
Address
The Indiana Clinical Trials Center, PC Site Number : 8400007
Plainfield, Indiana, 46168
Status
Recruiting
Address
Michael W. Simon, M.D., PSC Site Number : 8400073
Lexington, Kentucky, 40517
Status
Recruiting
Address
Family Allergy and Asthma Research Site Number : 8400060
Louisville, Kentucky, 40215
Status
Recruiting
Address
Dermatology Associates PC Site Number : 8400049
Rockville, Maryland, 20850
Status
Recruiting
Address
Michigan Dermatology Institute Site Number : 8400059
Waterford, Michigan, 48328
Status
Completed
Address
Children's Mercy Hospital and Clinics Site Number : 8400020
Kansas City, Missouri, 64111
Status
Completed
Address
Viable Research Management Site Number : 8400027
Las Vegas, Nevada, 89120
Status
Recruiting
Address
Tokunbo T. Dada, MD PA Site Number : 8400079
Irvington, New Jersey, 07111
Status
Recruiting
Address
Family Pediatrics Iwuozo L Obilo Md Site Number : 8400077
Newark, New Jersey, 07104
Status
Recruiting
Address
Providence Medical Center Site Number : 8400081
North Plainfield, New Jersey, 07060
Status
Recruiting
Address
VAMA Medical Health Center Site Number : 8400083
Union, New Jersey, 07083-5714
Status
Recruiting
Address
Philip Fried, M.D., PLLC Site Number : 8400029
Bronx, New York, 10463
Status
Recruiting
Address
Tiga Pediatrics, PC Site Number : 8400037
Bronx, New York, 10463
Status
Recruiting
Address
UNC Hospitals Site Number : 8400016
Chapel Hill, North Carolina, 27514
Status
Recruiting
Address
2G Clinical Research Services Site Number : 8400031
Durham, North Carolina, 27713
Status
Recruiting
Address
Clinical Research of Gastonia Site Number : 8400041
Gastonia, North Carolina, 28054
Status
Recruiting
Address
Cincinnati Children's Hospital Medical Center Site Number : 8400017
Cincinnati, Ohio, 45229
Status
Recruiting
Address
Dermatology Associates of Mid-Ohio Site Number : 8400052
Marion, Ohio, 43302
Status
Completed
Address
Cyn3rgy Research & Development Site Number : 8400023
Gresham, Oregon, 97030
Status
Recruiting
Address
MUSC Site Number : 8400013
Charleston, South Carolina, 29425
Status
Recruiting
Address
Allergic Disease and Asthma Research Center, PA Site Number : 8400048
Greenville, South Carolina, 29607
Status
Recruiting
Address
Amarillo Center for Clinical Research Site Number : 8400055
Amarillo, Texas, 79124
Status
Recruiting
Address
Pediatric Dermatology of North Texas Site Number : 8400003
Grapevine, Texas, 76051
Status
Recruiting
Address
Heights Dermatology and Aesthetic Center Site Number : 8400065
Houston, Texas, 77008
Status
Recruiting
Address
The Dermatology Institute of South Texas Site Number : 8400076
McAllen, Texas, 78501
Status
Completed
Address
AIM Trials Site Number : 8400035
Plano, Texas, 75093
Status
Recruiting
Address
Medical College Of Wisconsin Site Number : 8400008
Milwaukee, Wisconsin, 53226
International Sites
Status
Recruiting
Address
Investigational Site Number : 0320002
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1181ACH
Status
Recruiting
Address
Investigational Site Number : 0320006
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1056ABJ
Status
Recruiting
Address
Investigational Site Number : 0320004
Rosario, Santa Fe, S2000DBS
Status
Recruiting
Address
Investigational Site Number : 0320003
Buenos Aires, , C1061AAA
Status
Recruiting
Address
Investigational Site Number : 0320001
Ciudad Autonoma Bs As, , C1121ABE
Status
Recruiting
Address
Investigational Site Number : 0320005
Ciudad Autonoma Buenos Aires, , C1270AAN
Status
Recruiting
Address
Investigational Site Number : 0320007
San Miguel de Tucuman, , T4000AXL
Status
Recruiting
Address
Investigational Site Number : 0360009
Campbelltown, New South Wales, 2560
Status
Recruiting
Address
Investigational Site Number : 0360008
Kogarah, New South Wales, 2217
Status
Recruiting
Address
Investigational Site Number : 0360001
Westmead, New South Wales, 2145
Status
Recruiting
Address
Investigational Site Number : 0360010
Box Hill, Victoria, 3128
Status
Recruiting
Address
Investigational Site Number : 0360003
Parkville, Victoria, 3052
Status
Recruiting
Address
Investigational Site Number : 0360007
Richmond, Victoria, 3121
Status
Recruiting
Address
Investigational Site Number : 0360004
Fremantle, Western Australia, 6160
Status
Recruiting
Address
Universidade Federal do Paraná Site Number : 0760003
Curitiba, Paraná, 80060-000
Status
Recruiting
Address
HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760004
Curitiba, Paraná, 80060-900
Status
Recruiting
Address
HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760005
Curitiba, Paraná, 80060-900
Status
Recruiting
Address
Irmandade da Santa Casa de Misericórdia de Porto Alegre Site Number : 0760002
Porto Alegre, Rio Grande Do Sul, 90020-090
Status
Recruiting
Address
Hospital Sao Paulo Site Number : 0760006
São Paulo, São Paulo, 04037-002
Status
Recruiting
Address
Clínica de Alergia Martti Antila Site Number : 0760001
Sorocaba, , 18040-425
Status
Recruiting
Address
Investigational Site Number : 1240007
Calgary, Alberta, T3B 6A8
Status
Recruiting
Address
Investigational Site Number : 1240004
Calgary, Alberta, T3E 0B2
Status
Recruiting
Address
Investigational Site Number : 1240005
Winnipeg, Manitoba, R3C 0N2
Status
Recruiting
Address
Investigational Site Number : 1240001
Markham, Ontario, L3P 1X2
Status
Recruiting
Address
Investigational Site Number : 1240008
Toronto, Ontario, M5G 1X8
Status
Recruiting
Address
Investigational Site Number : 1240006
Montreal, Quebec, H3T 1C5
Status
Recruiting
Address
Investigational Site Number : 1240009
Regina, Saskatchewan, S4V 1R9
Status
Recruiting
Address
Investigational Site Number : 1560004
Beijing, , 100045
Status
Recruiting
Address
Investigational Site Number : 1560006
Changsha, , 410007
Status
Recruiting
Address
Investigational Site Number : 1560001
Chongqing, , 400014
Status
Recruiting
Address
Investigational Site Number : 1560012
Guangzhou, , 510091
Status
Recruiting
Address
Investigational Site Number : 1560007
Harbin, , 150010
Status
Recruiting
Address
Investigational Site Number : 1560003
Kunming, , 650034
Status
Recruiting
Address
Investigational Site Number : 1560011
Shenzhen, , 518020
Status
Recruiting
Address
Investigational Site Number : 1560002
Suzhou, , 215006
Status
Recruiting
Address
Investigational Site Number : 1560008
Xuzhou, , 221002
Status
Recruiting
Address
Investigational Site Number : 1700006
Barranquilla, , 080002
Status
Recruiting
Address
Investigational Site Number : 1700001
Bogota, , 110111
Status
Recruiting
Address
Investigational Site Number : 1700004
Bogota, , 111211
Status
Completed
Address
Investigational Site Number : 1700007
Bogota, , 111211
Status
Completed
Address
Investigational Site Number : 2080002
Kobenhavn Nv, , 2400
Status
Recruiting
Address
Investigational Site Number : 2500008
Argenteuil Cedex, , 95107
Status
Recruiting
Address
Investigational Site Number : 2500001
Bordeaux, , 33000
Status
Recruiting
Address
Investigational Site Number : 2500010
Lille cedex, , 59020
Status
Recruiting
Address
Investigational Site Number : 2500006
Marseille cedex 5, , 13385
Status
Recruiting
Address
Investigational Site Number : 2500005
Martigues, , 13500
Status
Recruiting
Address
Investigational Site Number : 2500002
Nantes Cedex 1, , 44120
Status
Recruiting
Address
Investigational Site Number : 2500003
Paris Cedex 15, , 75743
Status
Recruiting
Address
Investigational Site Number : 2500004
Saint-Etienne Cedex 2, , 42055
Status
Recruiting
Address
Investigational Site Number : 3000001
Athens, , 16121
Status
Recruiting
Address
Investigational Site Number : 3000004
Larissa, , 41500
Status
Recruiting
Address
Investigational Site Number : 3000003
Thessaloniki, , 54643
Status
Recruiting
Address
Investigational Site Number : 3000002
Thessaloniki, , 56429
Status
Recruiting
Address
Investigational Site Number : 3760003
Beer Sheva, , 84101
Status
Recruiting
Address
Investigational Site Number : 3760004
Haifa, , 31048
Status
Recruiting
Address
Investigational Site Number : 3760005
Kfar-Saba, , 44281
Status
Recruiting
Address
Investigational Site Number : 3760001
Ramat Gan, , 5266202
Status
Recruiting
Address
Investigational Site Number : 3760002
Rehovot, , 76100
Status
Recruiting
Address
Investigational Site Number : 3800004
Terracina, Latina, 04019
Status
Recruiting
Address
Investigational Site Number : 3800008
Naples, Napoli, 80122
Status
Recruiting
Address
Investigational Site Number : 3800006
Padua, Veneto, 35128
Status
Recruiting
Address
Investigational Site Number : 3800012
Bari, , 70124
Status
Recruiting
Address
Investigational Site Number : 3800003
Bologna, , 40138
Status
Recruiting
Address
Investigational Site Number : 3800010
Catania, , 95123
Status
Recruiting
Address
Investigational Site Number : 3800001
Milano, , 20122
Status
Recruiting
Address
Investigational Site Number : 3800005
Napoli, , 80131
Status
Recruiting
Address
Investigational Site Number : 3800011
Padova, , 35128
Status
Recruiting
Address
Investigational Site Number : 3800009
Perugia, , 06156
Status
Recruiting
Address
Investigational Site Number : 3800007
Trieste, , 34137
Status
Recruiting
Address
Investigational Site Number : 3920002
Hiroshima-shi, Hiroshima, 734-8551
Status
Recruiting
Address
Investigational Site Number : 3920009
Sagamihara-shi, Kanagawa, 252-0392
Status
Recruiting
Address
Investigational Site Number : 3920016
Yokohama-Shi, Kanagawa, 221-0825
Status
Recruiting
Address
Investigational Site Number : 3920012
Nagasaki-shi, Nagasaki, 852-8501
Status
Recruiting
Address
Investigational Site Number : 3920003
Habikino-shi, Osaka-Fu, 583-8588
Status
Recruiting
Address
Investigational Site Number : 3920011
Fuchu-shi, Tokyo, 183-8561
Status
Recruiting
Address
Investigational Site Number : 3920001
Setagaya-ku, Tokyo, 157-8535
Status
Recruiting
Address
Investigational Site Number : 3920018
Fukuoka-shi, , 813-0017
Status
Recruiting
Address
Investigational Site Number : 3920017
Fukuyama-shi, , 721-8511
Status
Recruiting
Address
Investigational Site Number : 3920015
Kumagaya-shi, , 360-0018
Status
Recruiting
Address
Investigational Site Number : 3920004
Kyoto-shi, , 602-8566
Status
Recruiting
Address
Investigational Site Number : 3920020
Nagoya-shi, , 460-0001
Status
Recruiting
Address
Investigational Site Number : 3920008
Obu-shi, , 474-8710
Status
Recruiting
Address
Investigational Site Number : 3920005
Osakasayama-shi, , 589-8511
Status
Recruiting
Address
Investigational Site Number : 3920014
Sendai-shi, , 983-8512
Status
Recruiting
Address
Investigational Site Number : 3920019
Sendai-shi, , 989-3126
Status
Recruiting
Address
Investigational Site Number : 3920010
Tsu-shi, , 514-0125
Status
Recruiting
Address
Investigational Site Number : 4100008
Ansan-si, Gyeonggi-do, 15355
Status
Recruiting
Address
Investigational Site Number : 4100007
Incheon, Gyeonggi-do, 22332
Status
Recruiting
Address
Investigational Site Number : 4100002
Suwon, Gyeonggi-do, 16499
Status
Recruiting
Address
Investigational Site Number : 4100001
Gumi-city, Gyeongsangbuk-do, 39371
Status
Recruiting
Address
Investigational Site Number : 4100003
Seoul, , 05278
Status
Recruiting
Address
Investigational Site Number : 4100005
Seoul, , 05505
Status
Active, not recruiting
Address
Investigational Site Number : 4100004
Seoul, , 06351
Status
Recruiting
Address
Investigational Site Number : 4840003
Monterrey, Nuevo León, 64460
Status
Recruiting
Address
Investigational Site Number : 4840001
Mexico, , 04530
Status
Recruiting
Address
Investigational Site Number : 4840006
Mexico, , 06720
Status
Recruiting
Address
Investigational Site Number : 4840004
Puebla, , 72190
Status
Recruiting
Address
Investigational Site Number : 4840005
Tlalnepantla, , 54055
Status
Completed
Address
Investigational Site Number : 5280001
Amsterdam, , 1105 AZ
Status
Recruiting
Address
Investigational Site Number : 5280006
Den Haag, , 2566 MJ
Status
Recruiting
Address
Investigational Site Number : 5280005
Groningen, , 9713 GZ
Status
Recruiting
Address
Investigational Site Number : 5280002
Rotterdam, , 3015 GD
Status
Recruiting
Address
Investigational Site Number : 5280003
Utrecht, , 3508 GA
Status
Recruiting
Address
Investigational Site Number : 5780001
Bergen, , 5021
Status
Recruiting
Address
Investigational Site Number : 5780002
Oslo, , 0027
Status
Recruiting
Address
Investigational Site Number : 6200003
Braga, , 4710-243
Status
Recruiting
Address
Investigational Site Number : 6200005
Lisboa, , 1169-050
Status
Recruiting
Address
Investigational Site Number : 6200001
Lisboa, , 1649-035
Status
Recruiting
Address
Investigational Site Number : 6430005
Moscow, , 109240
Status
Recruiting
Address
Investigational Site Number : 6430002
Moscow, , 115478
Status
Recruiting
Address
Investigational Site Number : 6430003
Moscow, , 117513
Status
Recruiting
Address
Investigational Site Number : 6430001
Moscow, , 119991
Status
Recruiting
Address
Investigational Site Number : 6430004
Moscow, , 125373
Status
Recruiting
Address
Investigational Site Number : 7240009
Santullano De Mieres, Asturias, 33611
Status
Recruiting
Address
Investigational Site Number : 7240005
Barcelona, Catalunya [Cataluña], 08950
Status
Completed
Address
Investigational Site Number : 7240008
Comunidad Valenciana, Valencia, 46014
Status
Recruiting
Address
Investigational Site Number : 7240001
Alicante, , 03010
Status
Recruiting
Address
Investigational Site Number : 7240002
Barcelona, , 08041
Status
Recruiting
Address
Investigational Site Number : 7240003
Madrid, , 28007