Observational Evaluation of Atopic Dermatitis in Pediatric Patients
- Conditions
- Dermatitis Atopic
- Interventions
- Other: Standard of care
- Registration Number
- NCT03687359
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
The study duration is 60 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1856
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with atopic dermatitis (AD) Standard of care Participants receive AD therapy as part of their usual care as determined by their physician independent of decision to enroll in the study.
- Primary Outcome Measures
Name Time Method Patient demographics Baseline (Month 0) Medical history of selected atopic diseases and comorbidities Baseline (Month 0) Age at onset of atopic dermatitis (AD) Baseline (Month 0) Personal and family history of AD and selected atopic diseases Baseline (Month 0) All prior and current systemic AD treatment Baseline (Month 0) All prior and current topical therapy and phototherapy for AD (including dose, route and frequency of administration for all AD treatment) Baseline (Month 0) Presence/severity of AD and selected atopic comorbid conditions Baseline to Month 120 Therapy for selected atopic comorbid conditions Baseline to Month 120
- Secondary Outcome Measures
Name Time Method Days missed from school for the patient and days missed from work for the primary caregiver due to AD Baseline to Month 120 Visits to healthcare professionals (HCPs) Baseline to Month 120 Treatments and prescribing patterns for pediatric AD Baseline to Month 120 Changes in physician assessment of disease burden (Eczema Area and Severity Index [EASI]) Baseline to Month 120 Changes in physician assessment of disease burden (Body Surface Area [BSA]) Baseline to Month 120 Changes in patient/caregiver-reported outcome (PRO): Patient-Oriented Eczema Measure (POEM) Baseline to Month 120 Change in PRO: Children's Dermatology Life Quality Index (CDLQI)/ Infant's Dermatitis Quality of Life (IDQOL) Baseline to Month 120 Change in PRO: Dermatitis Family Impact (DFI) Baseline to Month 120 Change in PRO: Peak Pruritus Numerical Rating Scale (NRS)/ Pruritus (Itch) NRS/ Worst scratching NRS Baseline to Month 120 Change in PRO: Caregiver Global Assessment of Disease (CGAD) Baseline to Month 120 Change in PRO: Days missed from school for the patient and days missed from work for the primary caregiver due to AD since last visit Baseline to Month 120 Change in PRO: Total Nasal Symptom Score (TNSS) Baseline to Month 120 Change in PRO: Pediatric Asthma Questionnaire (PAQ) Baseline to Month 120 Change in PRO: Juniper Asthma Control Questionnaire-5 (ACQ-5) Baseline to Month 120 Adverse event (AE) reporting Baseline to Month 120
Trial Locations
- Locations (179)
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- 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
Ciocca, Giovanna- Site Number : 8400018
🇺🇸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- 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
Philip Fried, M.D., PLLC- Site Number : 8400029
🇺🇸Bronx, New York, United States
Tiga Pediatrics, PC- Site Number : 8400037
🇺🇸Bronx, New York, United States
Park Plaza Dermatology- Site Number : 8400080
🇺🇸New York, 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
ACRC Trials - Pediatric Dermatology of North Texas- Site Number : 8400003
🇺🇸Grapevine, 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, Argentina
Investigational Site Number : 0320007
🇦🇷San Miguel de Tucuman, 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 : 0320006
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0320005
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Investigational Site Number : 0320010
🇦🇷Cordoba, Argentina
Investigational Site Number : 0320013
🇦🇷Salta, 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
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
🇨🇴Bogota, Colombia
Investigational Site Number : 1700004
🇨🇴Bogota, Colombia
Investigational Site Number : 2080002
🇩🇰Kobenhavn Nv, Denmark
Investigational Site Number : 2500008
🇫🇷Argenteuil Cedex, France
Investigational Site Number : 2500001
🇫🇷Bordeaux, France
Investigational Site Number : 2500010
🇫🇷Lille cedex, France
Investigational Site Number : 2500006
🇫🇷Marseille cedex 5, France
Investigational Site Number : 2500005
🇫🇷Martigues, France
Investigational Site Number : 2500002
🇫🇷Nantes, France
Investigational Site Number : 2500003
🇫🇷Paris cedex 15, France
Investigational Site Number : 2500011
🇫🇷Toulouse Cedex 9, 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
🇮🇱Be'er Sheva, 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 : 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 : 3800008
🇮🇹Caserta, Italy
Investigational Site Number : 3800010
🇮🇹Catania, Italy
Investigational Site Number : 3800001
🇮🇹Milano, Italy
Investigational Site Number : 3800005
🇮🇹Napoli, 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-shi, Japan
Investigational Site Number : 3920010
🇯🇵TSU, Mie, Japan
Investigational Site Number : 3920003
🇯🇵Habikino, Osaka, Japan
Investigational Site Number : 3920011
🇯🇵Fuchu, Tokyo, Japan
Investigational Site Number : 3920018
🇯🇵Fukuoka-shi, 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-shi, Japan
Investigational Site Number : 3920008
🇯🇵Obu-shi, Japan
Investigational Site Number : 3920005
🇯🇵Osakasayama-shi, Japan
Investigational Site Number : 3920014
🇯🇵Sendai-shi, Japan
Investigational Site Number : 3920019
🇯🇵Sendai-shi, Japan
Investigational Site Number : 3920001
🇯🇵Tokyo, Japan
Investigational Site Number : 4100008
🇰🇷Ansan-si, Gyeonggi-do, Korea, Republic of
Investigational Site Number : 4100002
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Investigational Site Number : 4100007
🇰🇷Incheon, Incheon-gwangyeoksi, Korea, Republic of
Investigational Site Number : 4100001
🇰🇷Seoul, Korea, Republic of
Investigational Site Number : 4100003
🇰🇷Seoul, Korea, Republic of
Investigational Site Number : 4100005
🇰🇷Seoul, Korea, Republic of
Investigational Site Number : 4100004
🇰🇷Seoul, Korea, Republic of
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
🇲🇽Mexico, Mexico
Investigational Site Number : 4840006
🇲🇽Mexico, Mexico
Investigational Site Number : 4840004
🇲🇽Puebla, Mexico
Investigational Site Number : 4840005
🇲🇽Tlalnepantla de Baz, Mexico
Investigational Site Number : 5280001
🇳🇱Amsterdam, Netherlands
Investigational Site Number : 5280006
🇳🇱Den Haag, Netherlands
Investigational Site Number : 5280005
🇳🇱Groningen, Netherlands
Investigational Site Number : 5280002
🇳🇱Rotterdam, 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
🇵🇹Lisboa, Portugal
Investigational Site Number : 6200001
🇵🇹Lisboa, Portugal
Investigational Site Number : 6200006
🇵🇹Porto, Portugal
Investigational Site Number : 6430005
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6430002
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6430003
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6430001
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6430004
🇷🇺Moscow, Russian Federation
Investigational Site Number : 7240009
🇪🇸Mieres, Asturias, Spain
Investigational Site Number : 7240005
🇪🇸Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240012
🇪🇸Pozuelo de Alarcón, Madrid, 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