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Este Estudio es un Registro de Enfermedades No Intervencionista de Pacientes Adolescentes y Adultos con Dermatitis Atópica que Inician o Cambian Cualquier Tratamiento Sistémico (ARMADA-AD)

30 de octubre de 2026 actualizado por: Sanofi

Registro de Enfermedades de Dermatitis Atópica de Pacientes Adultos y Adolescentes que Inician o Cambian Tratamientos Sistémicos

The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions.

The study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Tipo de estudio

De observación

Inscripción (Estimado)

1000

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Trial Transparency email recommended (Toll free for US & Canada)
  • Número de teléfono: option 6 800-633-1610
  • Correo electrónico: Contact-US@sanofi.com

Ubicaciones de estudio

  • Arabia Saudita
      • Jeddah, Arabia Saudita, 21452
        • Reclutamiento
        • Erfan and Bagedo Hospital-Site Number : 6820002
        • Contacto:
        • Investigador principal:
          • Ahmed Ismail Ebraheem Abdellateef
      • Jeddah, Arabia Saudita, 23421
        • Reclutamiento
        • Medical Fakeeh-Site Number : 6820003
        • Contacto:
        • Investigador principal:
          • Ayman Elgendi
      • Riyadh, Arabia Saudita, 12231
        • Reclutamiento
        • King Fahad Medical City-Site Number : 6820001
        • Contacto:
        • Investigador principal:
          • Mohammed Alajlan
  • Canadá
    • Saskatchewan
      • Regina, Saskatchewan, Canadá, S4V 1R9
        • Reclutamiento
        • Origins Dermatology Centre-Site Number : 1240003
        • Investigador principal:
          • Rachel Asiniwasis
        • Contacto:
  • Emiratos Árabes Unidos
      • Abu Dhabi, Emiratos Árabes Unidos, 66566
        • Reclutamiento
        • Mediclinic Hospital, AUH-Site Number: 7840004
        • Contacto:
        • Investigador principal:
          • Hussein Abdel Dayem
      • Abu Dhabi, Emiratos Árabes Unidos, 6222
        • Reclutamiento
        • NMC Specialty Hospital-Site Number : 7840002
        • Contacto:
        • Investigador principal:
          • Ahmed Ameen
      • Al Karama, Emiratos Árabes Unidos, 50730
        • Reclutamiento
        • Dr Joseph Polyclinic Amber Clinic-Site Number: 7840005
        • Contacto:
        • Investigador principal:
          • Srikumar Goturu
      • Dubai, Emiratos Árabes Unidos, 00000
        • Reclutamiento
        • Dermatology and Aesthetic Center Rashid Hospital-Site Number : 7840003
        • Contacto:
        • Investigador principal:
          • Amani Abdulla Rahma Alfalasi
  • España
      • Alicante, España, 03010
        • Reclutamiento
        • Hospital General Universitario Dr. Balmis-Site Number: 7240005
        • Investigador principal:
          • Juan Francisco Silvestre Salvador
        • Contacto:
          • Juan Francisco Silvestre Salvador
          • Número de teléfono: +34965913723
          • Correo electrónico: silvestre.jfr@gmail.com
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], España, 08041
        • Reclutamiento
        • Investigational Site Number : 7240006
    • Tenerife
      • Santa Cruz de Tenerife, Tenerife, España, 38320
        • Reclutamiento
        • Hospital Universitario de Canarias-Site Number: 7240008
        • Investigador principal:
          • Ruperto Gonzalez Perez
        • Contacto:
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35244
        • Reclutamiento
        • Cahaba Dermatology & Skin Health Center- Site Number : 8400006
        • Investigador principal:
          • Vlada Groysman
        • Contacto:
      • Montgomery, Alabama, Estados Unidos, 36117
        • Reclutamiento
        • River Region Dermatology and Laser- Site Number : 8400041
        • Investigador principal:
          • Porcia Love
        • Contacto:
    • Arizona
      • Gilbert, Arizona, Estados Unidos, 85234
        • Reclutamiento
        • San Tan Allergy & Asthma- Site Number : 8400031
        • Contacto:
        • Investigador principal:
          • Sam Reed Shimamoto
      • Phoenix, Arizona, Estados Unidos, 85008
        • Reclutamiento
        • Saguaro Dermatology- Site Number : 8400028
        • Investigador principal:
          • Dathan Hamann
        • Contacto:
    • California
      • Bakersfield, California, Estados Unidos, 93301
        • Reclutamiento
        • Kern Research, Inc.- Site Number : 8400047
        • Investigador principal:
          • Tonny Tanus
        • Contacto:
      • Fremont, California, Estados Unidos, 94538
        • Reclutamiento
        • Center for Dermatology Clinical Research- Site Number : 8400014
        • Investigador principal:
          • Sunil Dhawan
        • Contacto:
          • Sunil Dhawan
          • Número de teléfono: 510-797-4111
          • Correo electrónico: sdhaw@yahoo.com
      • Los Angeles, California, Estados Unidos, 90045
        • Reclutamiento
        • Dermatology Research Associates - Los Angeles- Site Number : 8400020
        • Investigador principal:
          • Howard Sofen
        • Contacto:
          • Howard Sofen
          • Número de teléfono: 310-337-7171
          • Correo electrónico: hsofen@ucla.edu
      • Northridge, California, Estados Unidos, 91325
        • Reclutamiento
        • Northridge Clinical Trials, LLC- Site Number : 8400009
        • Investigador principal:
          • Navid Ezra
        • Contacto:
      • Oakland, California, Estados Unidos, 94596
        • Reclutamiento
        • Sunwise Clinical Research, LLC.- Site Number : 8400010
        • Contacto:
          • Michael Abdel Malek
          • Número de teléfono: 9252985147
          • Correo electrónico: mike@sunclin.com
        • Investigador principal:
          • Michael Abdel Malek
      • Pomona, California, Estados Unidos, 91767
        • Reclutamiento
        • Empire Clinical Research, LLC- Site Number : 8400007
        • Contacto:
          • Usha Mantha
        • Investigador principal:
          • Usha Mantha
      • San Diego, California, Estados Unidos, 92123
        • Reclutamiento
        • University Clinical Trials- Site Number : 8400019
        • Investigador principal:
          • Walter Nahm
        • Contacto:
          • Walter Nahm
          • Número de teléfono: 85827884701005
          • Correo electrónico: walter@univct.com
    • Colorado
      • Wheat Ridge, Colorado, Estados Unidos, 80033
        • Reclutamiento
        • Western States Clinical Research, Inc.- Site Number : 8400051
        • Investigador principal:
          • Jeffrey Rumbyrt
        • Contacto:
    • Florida
      • Doral, Florida, Estados Unidos, 33172
        • Reclutamiento
        • St. Jude Clinical Research- Site Number : 8400049
        • Contacto:
        • Investigador principal:
          • Gustavo Torres
      • North Miami Beach, Florida, Estados Unidos, 33162-4708
        • Reclutamiento
        • Ziaderm Research, LLC- Site Number : 8400021
        • Investigador principal:
          • Tory Sullivan
        • Contacto:
    • Georgia
      • Macon, Georgia, Estados Unidos, 31217
        • Reclutamiento
        • Skin Care Physicians of Georgia - Macon- Site Number : 8400034
        • Investigador principal:
          • David Cohen
        • Contacto:
          • David Cohen
          • Número de teléfono: 478-742-2180
          • Correo electrónico: bedadoc@aol.com
    • Illinois
      • Normal, Illinois, Estados Unidos, 61761
        • Reclutamiento
        • Sneeze, Wheeze, & Itch Associates, LLC- Site Number : 8400029
        • Investigador principal:
          • Dareen Siri
        • Contacto:
      • North Chicago, Illinois, Estados Unidos, 60064
        • Reclutamiento
        • Rosalind Franklin University of Medicine and Science- Site Number: 8400056
        • Investigador principal:
          • Raj Chovatiya
        • Contacto:
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48103
        • Reclutamiento
        • David Fivenson, MD, Dermatology, PLLC- Site Number : 8400017
        • Investigador principal:
          • David Fivenson
        • Contacto:
      • Auburn Hills, Michigan, Estados Unidos, 48326
        • Reclutamiento
        • Oakland Hills Dermatology- Site Number : 8400042
        • Investigador principal:
          • Christofer Buatti
        • Contacto:
      • Bay City, Michigan, Estados Unidos, 48706
        • Reclutamiento
        • Great Lakes Research Group - Bay City- Site Number : 8400052
        • Investigador principal:
          • Brent Boyce
        • Contacto:
          • Brent Boyce
          • Número de teléfono: 989-895-9100
          • Correo electrónico: bboyce@glrg.net
      • Caledonia, Michigan, Estados Unidos, 49316
        • Reclutamiento
        • The Derm Institute of West Michigan- Site Number : 8400025
        • Investigador principal:
          • Kristi Hawley
        • Contacto:
        • Contacto:
      • Detroit, Michigan, Estados Unidos, 48201
        • Reclutamiento
        • Wayne State University - Detroit Medical Center- Site Number : 8400035
        • Investigador principal:
          • Steven Daveluy
        • Contacto:
      • Waterford, Michigan, Estados Unidos, 48328
        • Reclutamiento
        • Michigan Dermatology Institute - Waterford- Site Number : 8400013
        • Contacto:
        • Investigador principal:
          • Cory Rubin
    • Missouri
      • Bolivar, Missouri, Estados Unidos, 65613
        • Reclutamiento
        • Red River Research Partners, Llc- Site Number : 8400054
        • Contacto:
        • Investigador principal:
          • Murphy Mastin
      • Kirksville, Missouri, Estados Unidos, 63501
        • Reclutamiento
        • Cleaver Dermatology- Site Number : 8400033
        • Contacto:
        • Investigador principal:
          • David Cleaver
    • Nebraska
      • Lincoln, Nebraska, Estados Unidos, 68510
        • Reclutamiento
        • Allergy Asthma & Immunology- Site Number : 8400044
        • Investigador principal:
          • Robert Szalewski
        • Contacto:
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89144
        • Reclutamiento
        • Las Vegas Dermatology- Site Number : 8400002
        • Investigador principal:
          • Harry Greenberg
        • Contacto:
    • New Hampshire
      • Portsmouth, New Hampshire, Estados Unidos, 03801
        • Reclutamiento
        • Optima Research Portsmouth- Site Number : 8400032
        • Investigador principal:
          • Abel Jarell
        • Contacto:
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87106
        • Reclutamiento
        • University Of New Mexico School Of Medicine- Site Number : 8400022
    • North Carolina
      • Huntersville, North Carolina, Estados Unidos, 28078
        • Reclutamiento
        • Piedmont Plastic Surgery and Dermatology- Site Number : 8400038
        • Contacto:
        • Investigador principal:
          • Nicole Seminara Zambrzycka
      • Winston-Salem, North Carolina, Estados Unidos, 27104
        • Reclutamiento
        • Wake Forest University Health Sciences- Site Number : 8400003
        • Investigador principal:
          • Steven Feldman
        • Contacto:
    • North Dakota
      • Fargo, North Dakota, Estados Unidos, 58103
        • Reclutamiento
        • Red River Research Partners - Fargo- Site Number : 8400037
        • Investigador principal:
          • Michael Blankinship
        • Contacto:
    • Ohio
      • Marion, Ohio, Estados Unidos, 43302
        • Reclutamiento
        • Dermatology Associates of Mid-Ohio- Site Number : 8400026
        • Contacto:
          • George Scott Drew
          • Número de teléfono: 740-244-8559
          • Correo electrónico: spfxv@aol.com
        • Investigador principal:
          • George Scott Drew
      • Mason, Ohio, Estados Unidos, 45040
        • Reclutamiento
        • Dermatologists of Southwest Ohio - Mason- Site Number : 8400050
        • Investigador principal:
          • Rocco Serrao
        • Contacto:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Reclutamiento
        • UPMC - Department of Dermatology- Site Number : 8400024
        • Investigador principal:
          • Joe Tung
        • Contacto:
          • Joe Tung
          • Número de teléfono: 412-647-2013
          • Correo electrónico: tungjk@upmc.edu
    • Rhode Island
      • Warwick, Rhode Island, Estados Unidos, 02886
        • Reclutamiento
        • Care Access Research - Warwick 2- Site Number : 8400045
        • Contacto:
        • Investigador principal:
          • John Zwetchkenbaum
    • South Carolina
      • Spartanburg, South Carolina, Estados Unidos, 29307
        • Reclutamiento
        • Advanced Dermatology and Cosmetic Surgery - Spartanburg- Site Number : 8400004
        • Contacto:
        • Investigador principal:
          • Amylynne Frankel
    • Texas
      • Dallas, Texas, Estados Unidos, 75235
        • Reclutamiento
        • Reveal Research Institute - Dallas- Site Number : 8400012
        • Investigador principal:
          • Aaron Farberg
        • Contacto:
      • Fort Worth, Texas, Estados Unidos, 76244
        • Terminado
        • Innovate Research - Fort Worth- Site Number : 8400016
      • Pflugerville, Texas, Estados Unidos, 78660
        • Reclutamiento
        • Austin Institute for Clinical Research, Inc- Site Number : 8400030
        • Investigador principal:
          • Edward Lain
        • Contacto:
      • Sugar Land, Texas, Estados Unidos, 77479
        • Reclutamiento
        • Complete Dermatology - Sugar Land- Site Number : 8400001
        • Investigador principal:
          • Bartley Gill
        • Contacto:
    • Utah
      • Bountiful, Utah, Estados Unidos, 84010
        • Reclutamiento
        • Cope Family Medicine - Ogden Clinic- Site Number : 8400053
      • Springville, Utah, Estados Unidos, 84663
        • Reclutamiento
        • Springville Dermatology - Springville- Site Number : 8400055
        • Contacto:
        • Investigador principal:
          • Michael Peterson
    • Virginia
      • Falls Church, Virginia, Estados Unidos, 22042
        • Reclutamiento
        • Fuchs Dermatology- Site Number : 8400027
        • Contacto:
        • Investigador principal:
          • Aaron Fuchs
    • Washington
      • Mill Creek, Washington, Estados Unidos, 98012
        • Reclutamiento
        • Frontier Dermatology Partners CRO LLC- Site Number : 8400011
        • Contacto:
        • Investigador principal:
          • Eingun James Song
      • Seattle, Washington, Estados Unidos, 98105
        • Reclutamiento
        • University of Washington - Roosevelt Location- Site Number : 8400005
        • Contacto:
          • Vivian Shi
          • Número de teléfono: 501-526-6994
          • Correo electrónico: dermtrials@uw.edu
        • Investigador principal:
          • Vivian Shi
  • Francia
    • Doubs
      • Besançon, Doubs, Francia, 25030
        • Reclutamiento
        • CHU Besançon - Hôpital Jean Minjoz-Site Number: 2500010
        • Investigador principal:
          • Francois Aubin
        • Contacto:
    • Drome
      • Valence, Drome, Francia, 26000
        • Reclutamiento
        • Centre Hospitalier de Valence-Site Number: 2500005
        • Contacto:
        • Investigador principal:
          • Anne Grange
    • Haut Rhin
      • Mulhouse, Haut Rhin, Francia, 68100
        • Reclutamiento
        • GHRMSA - Hospital Emile Muller-Site Number : 2500006
        • Contacto:
          • Catherine Michel
          • Número de teléfono: +33389646185
          • Correo electrónico: michelc@ghrmsa.fr
        • Investigador principal:
          • Catherine Michel
    • Reunion
      • Saint-Pierre, Reunion, Francia, 97448
        • Reclutamiento
        • CHU de La Reunion-Site Number: 2500007
        • Investigador principal:
          • Antoine Bertolotti
        • Contacto:
          • Antoine Bertolotti
    • Rhone
      • Romans-sur-Isère, Rhone, Francia, 26102
        • Reclutamiento
        • Hopitaux Drome Nord-Site Number : 2500002
        • Investigador principal:
          • Francois Skowron
        • Contacto:
    • Saone Et Loire
      • Chalon-sur-Saône, Saone Et Loire, Francia, 71100
        • Reclutamiento
        • Centre Hospitalier William Morey-Site Number: 2500008
        • Contacto:
        • Investigador principal:
          • Marie Dhers
    • Sarthe
      • Le Mans, Sarthe, Francia, 72037
        • Reclutamiento
        • Centre Hospitalier du Mans-Site Number: 2500004
        • Contacto:
        • Investigador principal:
          • Nathalie Beneton Benhard
  • Italia
      • Ancona, Italia, 60126
        • Reclutamiento
        • Azienda Ospedaliero Universitaria delle Marche-Site Number: 3800009
        • Investigador principal:
          • Oriana Simonetti
        • Contacto:
      • Novara, Italia, 28100
        • Reclutamiento
        • Ospedale Maggiore di Novara-Site Number: 3800005
        • Contacto:
        • Investigador principal:
          • Paola Savoia
      • Reggio Emilia, Italia, 42100
        • Reclutamiento
        • Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia-Site Number : 3800006
        • Contacto:
        • Investigador principal:
          • Vito Di Lernia
      • Roma, Italia, 00144
        • Reclutamiento
        • Istituto San Gallicano IRCCS - Istituti Fisioterapici Ospitalieri-Site Number: 3800002
        • Contacto:
        • Investigador principal:
          • Maria Concetta Fargnoli
  • Japón
    • Kagawa-ken
      • Marugame-shi, Kagawa-ken, Japón, 763-0074
        • Reclutamiento
        • Takeoka Dermatology Clinic- Site Number : 3920005
        • Contacto:
        • Investigador principal:
          • Shintaro Takeoka
    • Osaka
      • Habikino-shi, Osaka, Japón, 583-8588
        • Reclutamiento
        • Osaka Habikino Medical Center-Site Number : 3920001
        • Investigador principal:
          • Yoko Kataoka
        • Contacto:
    • Shizuoka
      • Hamamatsu, Shizuoka, Japón, 430-0929
        • Reclutamiento
        • JA-Shizuoka Enshu Hospital-Site Number: 3920003
        • Contacto:
        • Investigador principal:
          • Chika Shibuya
  • Porcelana
      • Chongqing, Porcelana, 400016
        • Reclutamiento
        • The First Affiliated Hospital of Chongqing Medical University-Site Number : 1560011
        • Contacto:
        • Investigador principal:
          • Tao Cai
      • Shanghai, Porcelana, 200040
        • Reclutamiento
        • Huashan Hospital, Fudan University-Site Number: 1560012
        • Investigador principal:
          • Wei Li
        • Contacto:
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana, 100191
        • Reclutamiento
        • Peking University Third Hospital-Site Number: 1560008
        • Investigador principal:
          • Wenhui Wang
        • Contacto:
          • Wenhui Wang
          • Número de teléfono: +8618618269437
          • Correo electrónico: wwh0608@126.com
    • Guangdong
      • Shenzhen, Guangdong, Porcelana, 518033
        • Reclutamiento
        • The Eighth Affiliated Hospital, Sun Yat-sen University-Site Number: 1560006
        • Contacto:
          • Peimei Zhou
          • Número de teléfono: +8613880699378
          • Correo electrónico: 46551704@qq.com
        • Investigador principal:
          • Peimei Zhou
    • Hu'nan
      • Changsha, Hu'nan, Porcelana, 410008
        • Reclutamiento
        • Xiangya Hospital of Central South University-Site Number : 1560001
        • Investigador principal:
          • Juan Su
        • Contacto:
          • Juan Su
          • Número de teléfono: +8615116408921
          • Correo electrónico: 540020068@qq.com
      • Changsha, Hu'nan, Porcelana, 410011
        • Reclutamiento
        • The Second Xiangya Hospital of Central South University-Site Number: 1560014
        • Investigador principal:
          • Yunsheng Liang
        • Contacto:
    • Shanxi
      • Xi’an, Shanxi, Porcelana, 710004
        • Reclutamiento
        • The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)-Site Number: 1560002
        • Investigador principal:
          • Songmei Geng
        • Contacto:
    • Sichuan
      • Chengdu, Sichuan, Porcelana, 610041
        • Reclutamiento
        • West China Hospital, Sichuan University- Site Number: 1560003
        • Investigador principal:
          • Jingyi Li
        • Contacto:
          • Jingyi Li
          • Número de teléfono: +8618980605704
          • Correo electrónico: ljy7733@163.com
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana, 310006
        • Reclutamiento
        • Hangzhou First People's Hospital-Site Number: 1560004
        • Investigador principal:
          • Liming Wu
        • Contacto:
      • Hangzhou, Zhejiang, Porcelana, 310009
        • Reclutamiento
        • The Second Affiliated Hospital of Zhejiang University School of Medicine-Site Number: 1560007
        • Investigador principal:
          • Xiaoyong Man
        • Contacto:
          • Xiaoyong Man
          • Número de teléfono: +8613600516219
          • Correo electrónico: manxy@zju.edu.cn
      • Ningbo, Zhejiang, Porcelana, 315010
        • Reclutamiento
        • The First Affiliated Hospital of Ningbo University-Site Number : 1560009
        • Contacto:
          • Bingjiang Lin
          • Número de teléfono: +8617757461212
          • Correo electrónico: linbingj@163.com
        • Investigador principal:
          • Bingjiang Lin

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Patients with any atopic dermatitis severity will be invited to enroll in the registry after the decision has been made to initiate a new systemic medication for the first time or switch systemic therapies. Inclusion in the registry will not influence a patient's treatment course.

Descripción

Inclusion Criteria:

  • Patients aged more than or equal to (≥) 12 years at the time of consent.
  • Confirmed diagnosis of AD, of any severity, according to the Investigator's assessment as aligned with International Classification of Diseases 10th revision (ICD-10) code of L20.
  • Prescribed and scheduled to initiate any systemic treatment for AD (including but not limited to biologics, oral Janus kinase (JAK) inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil)
  • Signed informed consent for registry participation by the patient or parent/legal representative and assent by the patient appropriate to the patient's age, including willingness to participate in long-term follow-up.

Exclusion Criteria:

  • Concurrent participation in an interventional clinical trial that administers an investigational drug that modifies patient care.
  • Insufficient understanding of the study by the patient and/or parent/guardian.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: COHORT
  • Perspectivas temporales: PROSPECTIVE

Cohortes e Intervenciones

Grupo / Cohorte
Atopic Dermatitis

This study plans to collect information on adolescent and adult patients with atopic dermatitis who initiate or switch any systemic treatment (eg, biologics, oral Janus kinase [JAK] inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil) for AD according to the country-specific prescribing information. During the study, investigators will prescribe medical products for treatment of AD per standard of care (SoC) and per medical judgment.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants Utilizing Atopic Dermatitis (AD) Treatment
Periodo de tiempo: Baseline to up to 60 months

The number (and percentage) of participants taking AD treatments and treatments per patient will be described.
Baseline to up to 60 months
Duration of Treatment
Periodo de tiempo: Baseline to up to 60 months

The duration of AD treatments will be summarized descriptively.
Baseline to up to 60 months
AD Treatment Sequences
Periodo de tiempo: Baseline to up to 60 months

The ordering of AD treatments will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Initiating AD Treatments with Reasons
Periodo de tiempo: Baseline to up to 60 months

The number (and percentage) of patients initiating AD treatment and reasons for initiation will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Interrupting AD Treatment
Periodo de tiempo: Baseline to up to 60 months

The number (and percentage) of patients interrupting AD treatment and reasons for treatment interruption will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Discontinuing AD Treatment
Periodo de tiempo: Baseline to up to 60 months

The number (and percentage) of patients discontinuing AD treatment and reasons for treatment discontinuation will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Switching AD Treatments
Periodo de tiempo: Baseline to up to 60 months

The number (and percentage) of patients switching AD treatment and reasons for treatment switch will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Augmenting AD treatment
Periodo de tiempo: Baseline to up to 60 months

The number (and percentage) of patients augmenting AD treatment will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Modifying AD Treatment Dose
Periodo de tiempo: Baseline to up to 60 months

The number (and percentage) of patients modifying AD treatment dose, reasons for dose modification, and dosing will be summarized descriptively.
Baseline to up to 60 months
Change from Baseline in Extent and Severity of AD Measured with Eczema Area and Severity Index (EASI)
Periodo de tiempo: Baseline to up to 60 months

Clinical outcomes measured using EASI will be summarized at the start of a treatment episode and each follow-up time point.
Baseline to up to 60 months
Change from Baseline in Extent and Severity of AD Measured with Body Surface Area (BSA)
Periodo de tiempo: Baseline to up to 60 months

Clinical outcomes measured using BSA will be summarized at the start of a treatment episode and each follow-up time point.
Baseline to up to 60 months
Change from Baseline in Extent and Severity of AD Measured with Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD)
Periodo de tiempo: Baseline to up to 60 months

Clinical outcomes measured using vIGA-AD will be summarized at the start of a treatment episode and each follow-up time point.
Baseline to up to 60 months
Change from Baseline in Extent and Severity of AD Measured with Revised Investigator's Global Assessment for Atopic Dermatitis (rIGA-AD)
Periodo de tiempo: Baseline to up to 60 months

Clinical outcomes measured using rIGA-AD will be summarized at the start of a treatment episode and each follow-up time point.
Baseline to up to 60 months
Change in Atopic Dermatitis Control Test (ADCT) from Baseline
Periodo de tiempo: Baseline to up to 60 months

The ADCT is a 6-item patient-reported outcomes instrument with a 7-day recall period to measure AD disease control. Total score ranges from 0 to 24.
Baseline to up to 60 months
Change in Patient Global Impression of Severity (PGIS) from Baseline
Periodo de tiempo: Baseline to up to 60 months

The PGIS is a single item tool used to assess current severity of eczema symptoms, scored on a 5-point scale from 1 = no symptoms to 5 = very severe symptoms.
Baseline to up to 60 months
Change in Itch severity as Measured with the Peak Pruritus Numeric Rating Scale (PP-NRS) from Baseline
Periodo de tiempo: Baseline to up to 60 months

The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.
Baseline to up to 60 months
Change in Skin Pain as Measured with Skin Pain Numeric Rating Scale (SP-NRS) from Baseline
Periodo de tiempo: Baseline to up to 60 months

The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD during the past 24 hours, with 0 = no pain and 10 = worst possible pain imaginable.
Baseline to up to 60 months
Change in Sleep Disturbance as Measured with Sleep Disturbance Numeric Rating Scale (SD-NRS) from Baseline
Periodo de tiempo: Baseline to up to 60 months

The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD, with 0 being 'no sleep loss related to the symptoms of atopic dermatitis' and 10 being 'I did not sleep at all' due to the symptoms of atopic dermatitis.
Baseline to up to 60 months
Remission of AD
Periodo de tiempo: Baseline to up to 60 months

Total remission of all signs and symptoms of AD will be assessed.
Baseline to up to 60 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sociodemographic characteristics of Participants
Periodo de tiempo: Baseline

Demographics characteristics including age, sex, body weight, height, geographic region, education level, employment status, smoking and alcohol status will be collected.
Baseline
Ethnic Origin in Combination with Fitzpatrick Scale
Periodo de tiempo: Baseline

The Fitzpatrick Skin Type Scale was developed based on an individual's reaction to sun exposure and will be completed by the Investigator. Skin types range from I - VI, with scores of I indicating the palest skin tone with no inherent melanin pigmentation, and VI indicating the darkest skin tone with significant amount of melanin.
Baseline
Disease characteristics of Participants
Periodo de tiempo: Baseline

History of AD (including date of diagnosis, age of onset, specialty of provider who diagnosed condition), AD morphology, including but not limited to, patches, plaques, prurigo nodules, lichenoid papules, perifollicular papules, nummular lesions, and psoriasiform lesions and family history of AD and comorbidities will be collected.
Baseline
Change from Baseline in Dermatology-specific Quality of Life Measure with Dermatology Life Quality Index (DLQI)
Periodo de tiempo: Baseline to up to 60 months

DLQI is calculated by summing the score of each question resulting in a maximum score of 30 and a minimum score of 0 (higher scores indicate quality of life is more impaired).
Baseline to up to 60 months
Change from Baseline in Dermatology-specific Quality of Life Measure with Children's Dermatology Life Quality Index (CDLQI)
Periodo de tiempo: Baseline to up to 60 months

The CDLQI is calculated by summing the score of each question resulting in a maximum score of 30 and a minimum score of 0 (higher scores indicate quality of life is more impaired).
Baseline to up to 60 months
Change from Baseline in Burden of Assessment Using Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: Baseline to up to 60 months

PHQ-9 is a 9-item, validated, patient-reported questionnaire to assess depression which scores each of the 9 Diagnostic and Statistical Manual of Mental Disorders-IV criteria as "0" (not at all) to "3" (nearly every day). Possible scores range from 0 to 27 and are classified as 1-4: "minimal depression"; 5-9: "mild depression"; 10-14: "moderate depression"; 15-19: "moderately severe depression"; and 20-27: "severe depression".
Baseline to up to 60 months
Change from Baseline in AD Specific Work and Classroom Productivity and Impairment Assessed Using WPAI+CIQ
Periodo de tiempo: Baseline to up to 60 months

Work Productivity and Activity Impairment plus Classroom Impairment Questions (WPAI+CIQ) is a 10-item, patient-reported, validated questionnaire adapted for AD to measure impairments in work, classroom, and regular daily activities over a 7-day period.
Baseline to up to 60 months
Change from Baseline in Treatment Satisfaction Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Periodo de tiempo: Baseline to up to 60 months

The 14-item TSQM-9 is a generic measure of treatment satisfaction, assessing side effects, effectiveness, convenience and global satisfaction, over the last 2 to 3 weeks, or since the patient has last used it. A lower score indicates lower satisfaction with treatment.
Baseline to up to 60 months
Visits with Specialty of Attending Healthcare Provider and Reason for Visit
Periodo de tiempo: Baseline to up to 60 months

Health care resource utilization including visits with specialty of attending health care provider and reason for visit (example, disease flare-up, regular visit, prescription change, adverse event [AE]) will be assessed.
Baseline to up to 60 months
Hospitalizations for AD
Periodo de tiempo: Baseline to up to 60 months

Hospitalization for AD will be assessed.
Baseline to up to 60 months
Prevalence of Comorbid Atopic Conditions
Periodo de tiempo: Baseline to up to 60 months

Prevalence of comorbid atopic conditions (including but not limited to, asthma, allergic conjunctivitis, allergic rhinitis, eosinophilic esophagitis, nasal polyposis, food allergy, prurigo nodularis, chronic spontaneous urticaria, and rhinoconjunctivitis) and non-atopic conditions (including but not limited to, insomnia, anxiety, attention deficit disorder, depression, major adverse cardiovascular event, cardiovascular disease, skin infection, pulmonary disease, osteoporosis, fractures, contact allergy, and inflammatory conditions) will be assessed.
Baseline to up to 60 months
Incidence of Comorbid Atopic Conditions
Periodo de tiempo: Baseline to up to 60 months

Incidence of comorbid atopic conditions (including but not limited to, asthma, allergic conjunctivitis, allergic rhinitis, eosinophilic esophagitis, nasal polyposis, food allergy, prurigo nodularis, chronic spontaneous urticaria, and rhinoconjunctivitis) and non-atopic conditions (including but not limited to, insomnia, anxiety, attention deficit disorder, depression, major adverse cardiovascular event, cardiovascular disease, skin infection, pulmonary disease, osteoporosis, fractures, contact allergy, and inflammatory conditions) will be assessed.
Baseline to up to 60 months
Change from Baseline in Asthma Control Assessed with Asthma Control Questionnaire-5 (ACQ-5)
Periodo de tiempo: Baseline to up to 60 months

ACQ-5 is a 5-item questionnaire used to assess asthma control [33]. Each question is rated on a 7-point scale (0=no impairment; 6=maximum impairment). The ACQ-5 score is calculated using the mean of the 5 items and ranges between 0 (well controlled asthma) to 6 (extremely poorly controlled asthma). The ACQ-5 will only be completed by patients with comorbid asthma.
Baseline to up to 60 months
Occurrence of Concomitant Medication use for AD and Selected Comorbidities
Periodo de tiempo: Baseline to up to 60 months

The occurrence of concomitant medication use for AD and selected comorbidities at baseline and changes (including reason for change) will be summarized.
Baseline to up to 60 months
Number of Adverse Events (SAEs)
Periodo de tiempo: Baseline to up to 60 months

Number of patients experiencing AEs.
Baseline to up to 60 months
Number of Serious Adverse Events (SAEs)
Periodo de tiempo: Baseline to up to 60 months

Number of patients experiencing SAEs.
Baseline to up to 60 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Sanofi

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

17 de noviembre de 2025

Finalización primaria (Estimado)

30 de enero de 2034

Finalización del estudio (Estimado)

30 de enero de 2034

Fechas de registro del estudio

Enviado por primera vez

28 de noviembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

17 de diciembre de 2025

Publicado por primera vez (Actual)

18 de diciembre de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • OBS18388
  • U1111-1311-1824 (Identificador de registro: ICTRP)

Plan de datos de participantes individuales (IPD)

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Descripción del plan IPD

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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