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Observational Evaluation of Atopic Dermatitis in Pediatric Patients
Sponsor: Sanofi
Summary
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. Secondary Objectives: * 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.
Official title: Prospective, Observational, Longitudinal Study in Pediatric Patients With Moderate to Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable
Key Details
Gender
All
Age Range
0 Years - 11 Years
Study Type
OBSERVATIONAL
Enrollment
1860
Start Date
2019-08-15
Completion Date
2035-07-23
Last Updated
2025-08-15
Healthy Volunteers
No
Conditions
Interventions
Standard of care
Treatment as per standard practice
Locations (182)
C Squared Research Center- Site Number : 8400068
Birmingham, Alabama, United States
Cahaba Dermatology & Skin Health Center- Site Number : 8400046
Birmingham, Alabama, United States
C2 Research Center, LLC- Site Number : 8400071
Montgomery, Alabama, United States
Phoenix Children's Hospital, Inc.- Site Number : 8400015
Phoenix, Arizona, United States
Orange County Research Institute- Site Number : 8400028
Anaheim, California, United States
Axis Clinical Trials- Site Number : 8400025
Los Angeles, California, United States
Madera Family Medical Group- Site Number : 8400054
Madera, California, United States
Carey Chronis, MD, FAAP- Site Number : 8400033
Ventura, California, United States
Daxia Trials- Site Number : 8400082
Boca Raton, Florida, United States
Frieder Dermatology- Site Number : 8400085
Boca Raton, Florida, United States
Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology, LLC- Site Number : 8400072
Coral Gables, Florida, United States
Green Dermatology and Cosmetic Center. Site Number : 8400078
Deerfield Beach, Florida, United States
Amedica Research Institute, Inc.- Site Number : 8400067
Hialeah, Florida, United States
Eastern Research, Inc.- Site Number : 8400032
Hialeah, Florida, United States
Premier Dermatology Partners- Site Number : 8400075
Miami, Florida, United States
Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400074
Miami, Florida, United States
Vista Health Research, LLC- Site Number : 8400034
Miami, Florida, United States
Pediatric & Adult Research Center- Site Number : 8400040
Orlando, Florida, United States
Elias Dermatology LLC- Site Number : 8400086
Pembroke Pines, Florida, United States
Elias Dermatology LLC- Site Number : 8400087
Pembroke Pines, Florida, United States
Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400056
Columbus, Georgia, United States
Northwestern University Feinberg School of Medicine- Site Number : 8400001
Chicago, Illinois, United States
NorthShore University HealthSystem - Skokie- Site Number : 8400064
Skokie, Illinois, United States
The Indiana Clinical Trial Center - Plainfield - Edwards Drive- Site Number : 8400007
Plainfield, Indiana, United States
The Indiana Clinical Trials Center, PC Site Number : 8400007
Plainfield, Indiana, United States
Michael W. Simon, M.D., PSC- Site Number : 8400073
Lexington, Kentucky, United States
Dermatology Associates PC- Site Number : 8400049
Rockville, Maryland, United States
Michigan Dermatology Institute Site Number : 8400059
Waterford, Michigan, United States
Tokunbo T. Dada, MD PA- Site Number : 8400079
Irvington, New Jersey, United States
Family Pediatrics Iwuozo L Obilo Md- Site Number : 8400077
Newark, New Jersey, United States
Providence Medical Center- Site Number : 8400081
North Plainfield, New Jersey, United States
VAMA Medical Health Center- Site Number : 8400083
Union, New Jersey, United States
Park Plaza Dermatology- Site Number : 8400080
New York, New York, United States
Philip Fried, M.D., PLLC- Site Number : 8400029
The Bronx, New York, United States
Tiga Pediatrics, PC- Site Number : 8400037
The Bronx, New York, United States
UNC Hospitals- Site Number : 8400016
Chapel Hill, North Carolina, United States
2G Clinical Research Services- Site Number : 8400031
Durham, North Carolina, United States
Clinical Research Of Gastonia- Site Number : 8400041
Gastonia, North Carolina, United States
Cincinnati Children's Hospital Medical Center- Site Number : 8400017
Cincinnati, Ohio, United States
Dermatology Associates of Mid-Ohio- Site Number : 8400052
Marion, Ohio, United States
MUSC- Site Number : 8400013
Charleston, South Carolina, United States
ADAC Research- Site Number : 8400048
Greenville, South Carolina, United States
Amarillo Center for Clinical Research- Site Number : 8400055
Amarillo, Texas, United States
Heights Dermatology & Aesthetic Center- Site Number : 8400065
Houston, Texas, United States
The Dermatology Institute of South Texas- Site Number : 8400076
McAllen, Texas, United States
Medical College Of Wisconsin- Site Number : 8400008
Milwaukee, Wisconsin, United States
Investigational Site Number : 0320009
Bahía Blanca, Buenos Aires, Argentina
Investigational Site Number : 0320003
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Investigational Site Number : 0320004
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320007
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320006
Buenos Aires, Argentina
Investigational Site Number : 0320001
Buenos Aires, Argentina
Investigational Site Number : 0320002
Buenos Aires, Argentina
Investigational Site Number : 0320008
Buenos Aires, Argentina
Investigational Site Number : 0320005
Ciudad Autonoma Buenos Aires, Argentina
Investigational Site Number : 0320010
Córdoba, Argentina
Investigational Site Number : 0320013
Salta, Argentina
Investigational Site Number : 0320007
San Miguel de Tucumán, Argentina
Investigational Site Number : 0360008
Kogarah, New South Wales, Australia
Investigational Site Number : 0360011
Sydney, New South Wales, Australia
Investigational Site Number : 0360009
Sydney, New South Wales, Australia
Investigational Site Number : 0360010
Melbourne, Victoria, Australia
Investigational Site Number : 0360003
Parkville, Victoria, Australia
Investigational Site Number : 0360007
Richmond, Victoria, Australia
Universidade Federal do Paraná- Site Number : 0760003
Curitiba, Paraná, Brazil
Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760004
Curitiba, Paraná, Brazil
Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760005
Curitiba, Paraná, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760002
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Alergia Martti Antila- Site Number : 0760001
Sorocaba, São Paulo, Brazil
IDERJ - Instituto de Dermatologia e Estética do Brasil- Site Number : 0760009
Rio de Janeiro, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto- Site Number : 0760007
Sao Jose Rio Preto, Brazil
Hospital Sao Paulo- Site Number : 0760006
São Paulo, Brazil
Investigational Site Number : 1240004
Calgary, Alberta, Canada
Investigational Site Number : 1240007
Calgary, Alberta, Canada
Investigational Site Number : 1240005
Winnipeg, Manitoba, Canada
Investigational Site Number : 1240010
Halifax, Nova Scotia, Canada
Investigational Site Number : 1240001
Markham, Ontario, Canada
Investigational Site Number : 1240008
Toronto, Ontario, Canada
Investigational Site Number : 1240006
Montreal, Quebec, Canada
Investigational Site Number : 1240009
Regina, Saskatchewan, Canada
Investigational Site Number : 1560004
Beijing, China
Investigational Site Number : 1560006
Changsha, China
Investigational Site Number : 1560001
Chongqing, China
Investigational Site Number : 1560012
Guangzhou, China
Investigational Site Number : 1560007
Harbin, China
Investigational Site Number : 1560005
Shanghai, China
Investigational Site Number : 1560011
Shenzhen, China
Investigational Site Number : 1560002
Suzhou, China
Investigational Site Number : 1560008
Xuzhou, China
Investigational Site Number : 1700006
Barranquilla, Colombia
Investigational Site Number : 1700001
Bogotá, Colombia
Investigational Site Number : 1700004
Bogotá, Colombia
Investigational Site Number : 2080002
København NV, Denmark
Investigational Site Number : 2500008
Argenteuil, France
Investigational Site Number : 2500001
Bordeaux, France
Investigational Site Number : 2500010
Lille, France
Investigational Site Number : 2500006
Marseille, France
Investigational Site Number : 2500005
Martigues, France
Investigational Site Number : 2500002
Nantes, France
Investigational Site Number : 2500003
Paris, France
Investigational Site Number : 2500011
Toulouse, France
Investigational Site Number : 3000004
Larissa, Greece
Investigational Site Number : 3000005
Thessaloniki, Greece
Investigational Site Number : 3000003
Thessaloniki, Greece
Investigational Site Number : 3000002
Thessaloniki, Greece
Investigational Site Number : 3760003
Beersheba, Israel
Investigational Site Number : 3760004
Haifa, Israel
Investigational Site Number : 3760005
Kefar Sava, Israel
Investigational Site Number : 3760001
Ramat Gan, Israel
Investigational Site Number : 3760002
Rehovot, Israel
Investigational Site Number : 3800004
Terracina, Latina, Italy
Investigational Site Number : 3800008
Naples, Napoli, Italy
Investigational Site Number : 3800011
Padua, Padova, Italy
Investigational Site Number : 3800006
Padua, Veneto, Italy
Investigational Site Number : 3800012
Bari, Italy
Investigational Site Number : 3800003
Bologna, Italy
Investigational Site Number : 3800014
Brescia, Italy
Investigational Site Number : 3800010
Catania, Italy
Investigational Site Number : 3800001
Milan, Italy
Investigational Site Number : 3800005
Naples, Italy
Investigational Site Number : 3800015
Pavia, Italy
Investigational Site Number : 3800009
Perugia, Italy
Investigational Site Number : 3800013
Reggio Emilia, Italy
Investigational Site Number : 3800018
Roma, Italy
Investigational Site Number : 3800007
Trieste, Italy
Investigational Site Number : 3920009
Sagamihara, Kanagawa, Japan
Investigational Site Number : 3920016
Yokohama, Kanagawa, Japan
Investigational Site Number : 3920010
Tsu, Mie-ken, Japan
Investigational Site Number : 3920003
Habikino, Osaka, Japan
Investigational Site Number : 3920011
Fuchū, Tokyo, Japan
Investigational Site Number : 3920018
Fukuoka, Japan
Investigational Site Number : 3920017
Fukuyama-shi, Japan
Investigational Site Number : 3920002
Hiroshima, Japan
Investigational Site Number : 3920015
Kumagaya-shi, Japan
Investigational Site Number : 3920004
Kyoto, Japan
Investigational Site Number : 3920012
Nagasaki, Japan
Investigational Site Number : 3920020
Nagoya, Japan
Investigational Site Number : 3920008
Obu-shi, Japan
Investigational Site Number : 3920005
Osakasayama-shi, Japan
Investigational Site Number : 3920014
Sendai, Japan
Investigational Site Number : 3920019
Sendai, Japan
Investigational Site Number : 3920001
Tokyo, Japan
Investigational Site Number : 3920016
Yokohama, Japan
Investigational Site Number : 4840010
Cuernavaca, Morelos, Mexico
Investigational Site Number : 4840003
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840009
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840008
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840001
México, Mexico
Investigational Site Number : 4840006
México, Mexico
Investigational Site Number : 4840004
Puebla City, Mexico
Investigational Site Number : 4840005
Tlalnepantla, Mexico
Investigational Site Number : 5280001
Amsterdam, Netherlands
Investigational Site Number : 5280005
Groningen, Netherlands
Investigational Site Number : 5280002
Rotterdam, Netherlands
Investigational Site Number : 5280006
The Hague, Netherlands
Investigational Site Number : 5280003
Utrecht, Netherlands
Investigational Site Number : 5780001
Bergen, Norway
Investigational Site Number : 5780002
Oslo, Norway
Investigational Site Number : 5780003
Stavanger, Norway
Investigational Site Number : 6200003
Braga, Portugal
Investigational Site Number : 6200005
Lisbon, Portugal
Investigational Site Number : 6200001
Lisbon, Portugal
Investigational Site Number : 6200006
Porto, Portugal
Investigational Site Number : 6430005
Moscow, Russia
Investigational Site Number : 6430002
Moscow, Russia
Investigational Site Number : 6430003
Moscow, Russia
Investigational Site Number : 6430001
Moscow, Russia
Investigational Site Number : 6430004
Moscow, Russia
Investigational Site Number : 4100008
Ansan-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100002
Suwon, Gyeonggi-do, South Korea
Investigational Site Number : 4100007
Incheon, Incheon-gwangyeoksi, South Korea
Investigational Site Number : 4100001
Seoul, South Korea
Investigational Site Number : 4100003
Seoul, South Korea
Investigational Site Number : 4100005
Seoul, South Korea
Investigational Site Number : 4100004
Seoul, South Korea
Investigational Site Number : 7240005
Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240012
Pozuelo de Alarcón, Madrid, Spain
Investigational Site Number : 7240009
Mieres, Principality of Asturias, Spain
Investigational Site Number : 7240011
Barcelona, Spain
Investigational Site Number : 7240002
Barcelona, Spain
Investigational Site Number : 7240003
Madrid, Spain
Investigational Site Number : 7240010
Madrid, Spain