AzTrials
AzTrials

Atopic DermatitisARMADA-ADNCT07290803

This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment

An observational study of Atopic Dermatitis, run by Sanofi at 82 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Atopic Dermatitis
Type of treatment
Pill or oral medicine
How many people
1,000 participants
Where
82 sitesin 9 countries
Study dates
17 Nov 2025to 30 Jan 2034
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

82 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Trial Transparency email recommended (Toll free for US & Canada) contact

800-633-1610 ext. option 6

Contact-US@sanofi.com

82 sites in 9 countries

United States46 sites, 45 recruiting

  • University Of New Mexico School Of Medicine- Site Number : 8400022

    Albuquerque, New Mexico, 87106

    Recruiting

  • David Fivenson, MD, Dermatology, PLLC- Site Number : 8400017

    Ann Arbor, Michigan, 48103

    David Fivenson, 734-222-9630, dfivenson@fivensondermatology.com

    David Fivenson

    Recruiting

  • Oakland Hills Dermatology- Site Number : 8400042

    Auburn Hills, Michigan, 48326

    Christofer Buatti, 248-858-2255, buattichris@yahoo.com

    Christofer Buatti

    Recruiting

  • Kern Research, Inc.- Site Number : 8400047

    Bakersfield, California, 93301

    Tonny Tanus, 661-864-7710, drttanus@kernresearch.com

    Tonny Tanus

    Recruiting

  • Great Lakes Research Group - Bay City- Site Number : 8400052

    Bay City, Michigan, 48706

    Brent Boyce, 989-895-9100, bboyce@glrg.net

    Brent Boyce

    Recruiting

  • Cahaba Dermatology & Skin Health Center- Site Number : 8400006

    Birmingham, Alabama, 35244

    Vlada Groysman, 205-778-1564, vlada.groysman@cahabaderm.com

    Vlada Groysman

    Recruiting

  • Red River Research Partners, Llc- Site Number : 8400054

    Bolivar, Missouri, 65613

    Murphy Mastin, 417-493-8553, mmastin@redriverresearchpartners.com

    Murphy Mastin

    Recruiting

  • Cope Family Medicine - Ogden Clinic- Site Number : 8400053

    Bountiful, Utah, 84010

    Recruiting

  • The Derm Institute of West Michigan- Site Number : 8400025

    Caledonia, Michigan, 49316

    Kristi Hawley, 616-512-4445, pi@derminstituteofwmi.com

    Kristi Hawley, 6165124445, pi@derminstituteofwmi.com

    Recruiting

  • Reveal Research Institute - Dallas- Site Number : 8400012

    Dallas, Texas, 75235

    Aaron Farberg, 97279792971, afarberg@revealinstitute.com

    Aaron Farberg

    Recruiting

  • Wayne State University - Detroit Medical Center- Site Number : 8400035

    Detroit, Michigan, 48201

    Steven Daveluy, 313-429-7854, sdaveluy@med.wayne.edu

    Steven Daveluy

    Recruiting

  • St. Jude Clinical Research- Site Number : 8400049

    Doral, Florida, 33172

    Gustavo Torres, 305-507-2273, gtorres@stjudeclinicalresearch.com

    Gustavo Torres

    Recruiting

  • Fuchs Dermatology- Site Number : 8400027

    Falls Church, Virginia, 22042

    Aaron Fuchs, 703-578-1770, aaron.fuchs@gmail.com

    Aaron Fuchs

    Recruiting

  • Red River Research Partners - Fargo- Site Number : 8400037

    Fargo, North Dakota, 58103

    Michael Blankinship, 701-941-9601, michael@redriverresearchpartners.com

    Michael Blankinship

    Recruiting

  • Innovate Research - Fort Worth- Site Number : 8400016

    Fort Worth, Texas, 76244

    Completed

  • Center for Dermatology Clinical Research- Site Number : 8400014

    Fremont, California, 94538

    Sunil Dhawan, 510-797-4111, sdhaw@yahoo.com

    Sunil Dhawan

    Recruiting

  • San Tan Allergy & Asthma- Site Number : 8400031

    Gilbert, Arizona, 85234

    Sam Reed Shimamoto, 4806266600, rshimamoto@santanallergy.com

    Sam Reed Shimamoto

    Recruiting

  • Piedmont Plastic Surgery and Dermatology- Site Number : 8400038

    Huntersville, North Carolina, 28078

    Nicole Seminara Zambrzycka, 800-785-3150, nseminaramd@onsiteclinical.com

    Nicole Seminara Zambrzycka

    Recruiting

  • Cleaver Dermatology- Site Number : 8400033

    Kirksville, Missouri, 63501

    David Cleaver, 660-627-7546, drdavid@cleaverderm.com

    David Cleaver

    Recruiting

  • Las Vegas Dermatology- Site Number : 8400002

    Las Vegas, Nevada, 89144

    Harry Greenberg, 702-456-3120, hlgreenberg@yahoo.com

    Harry Greenberg

    Recruiting

  • Allergy Asthma & Immunology- Site Number : 8400044

    Lincoln, Nebraska, 68510

    Robert Szalewski, 402-486-3430, rszalewski@allergyasthmaimm.com

    Robert Szalewski

    Recruiting

  • Dermatology Research Associates - Los Angeles- Site Number : 8400020

    Los Angeles, California, 90045

    Howard Sofen, 310-337-7171, hsofen@ucla.edu

    Howard Sofen

    Recruiting

  • Skin Care Physicians of Georgia - Macon- Site Number : 8400034

    Macon, Georgia, 31217

    David Cohen, 478-742-2180, bedadoc@aol.com

    David Cohen

    Recruiting

  • Dermatology Associates of Mid-Ohio- Site Number : 8400026

    Marion, Ohio, 43302

    George Scott Drew, 740-244-8559, spfxv@aol.com

    George Scott Drew

    Recruiting

  • Dermatologists of Southwest Ohio - Mason- Site Number : 8400050

    Mason, Ohio, 45040

    Rocco Serrao, 513-701-5526, rserrao@dermswohio.com

    Rocco Serrao

    Recruiting

  • Frontier Dermatology Partners CRO LLC- Site Number : 8400011

    Mill Creek, Washington, 98012

    Eingun James Song, 4252754404, eingun.song@frontierdermpartners.com

    Eingun James Song

    Recruiting

  • River Region Dermatology and Laser- Site Number : 8400041

    Montgomery, Alabama, 36117

    Porcia Love, 334-676-3366, drc.drlove@gmail.com

    Porcia Love

    Recruiting

  • Sneeze, Wheeze, & Itch Associates, LLC- Site Number : 8400029

    Normal, Illinois, 61761

    Dareen Siri, 309-452-0995, drsiri@asthma2.com

    Dareen Siri

    Recruiting

  • Rosalind Franklin University of Medicine and Science- Site Number: 8400056

    North Chicago, Illinois, 60064

    Raj Chovatiya, 847-578-3000, rchovatiya@docsdermgroup.com

    Raj Chovatiya

    Recruiting

  • Ziaderm Research, LLC- Site Number : 8400021

    North Miami Beach, Florida, 33162-4708

    Tory Sullivan, 305-652-8600, drtory@sullivandermatology.com

    Tory Sullivan

    Recruiting

  • Northridge Clinical Trials, LLC- Site Number : 8400009

    Northridge, California, 91325

    Navid Ezra, 714-375-5970, nezra@northridgetrials.com

    Navid Ezra

    Recruiting

  • Sunwise Clinical Research, LLC.- Site Number : 8400010

    Oakland, California, 94596

    Michael Abdel Malek, 9252985147, mike@sunclin.com

    Michael Abdel Malek

    Recruiting

  • Austin Institute for Clinical Research, Inc- Site Number : 8400030

    Pflugerville, Texas, 78660

    Edward Lain, 512-279-2545, drlain@atxresearch.com

    Edward Lain

    Recruiting

  • Saguaro Dermatology- Site Number : 8400028

    Phoenix, Arizona, 85008

    Dathan Hamann, 480-562-3610, dhamann@saguaroderm.com

    Dathan Hamann

    Recruiting

  • UPMC - Department of Dermatology- Site Number : 8400024

    Pittsburgh, Pennsylvania, 15213

    Joe Tung, 412-647-2013, tungjk@upmc.edu

    Joe Tung

    Recruiting

  • Empire Clinical Research, LLC- Site Number : 8400007

    Pomona, California, 91767

    Usha Mantha

    Usha Mantha

    Recruiting

  • Optima Research Portsmouth- Site Number : 8400032

    Portsmouth, New Hampshire, 03801

    Abel Jarell, 603-441-1075, ajarell@stracskin.com

    Abel Jarell

    Recruiting

  • University Clinical Trials- Site Number : 8400019

    San Diego, California, 92123

    Walter Nahm, 85827884701005, walter@univct.com

    Walter Nahm

    Recruiting

  • University of Washington - Roosevelt Location- Site Number : 8400005

    Seattle, Washington, 98105

    Vivian Shi, 501-526-6994, dermtrials@uw.edu

    Vivian Shi

    Recruiting

  • Advanced Dermatology and Cosmetic Surgery - Spartanburg- Site Number : 8400004

    Spartanburg, South Carolina, 29307

    Amylynne Frankel, 864-574-0017, drafrankel@adcsclinics.com

    Amylynne Frankel

    Recruiting

  • Springville Dermatology - Springville- Site Number : 8400055

    Springville, Utah, 84663

    Michael Peterson, 385-327-5115, michaelpeterson@cctresearch.com

    Michael Peterson

    Recruiting

  • Complete Dermatology - Sugar Land- Site Number : 8400001

    Sugar Land, Texas, 77479

    Bartley Gill, 281-240-4313, bj.gill1@gmail.com

    Bartley Gill

    Recruiting

  • Care Access Research - Warwick 2- Site Number : 8400045

    Warwick, Rhode Island, 02886

    John Zwetchkenbaum, 401-340-3695, john.zwetchkenbaum.pi@careaccess.com

    John Zwetchkenbaum

    Recruiting

  • Michigan Dermatology Institute - Waterford- Site Number : 8400013

    Waterford, Michigan, 48328

    Cory Rubin, 248-681-9541, cory.rubin@michigandermatologyinstitute.com

    Cory Rubin

    Recruiting

  • Western States Clinical Research, Inc.- Site Number : 8400051

    Wheat Ridge, Colorado, 80033

    Jeffrey Rumbyrt, 303-940-9773, jrumbyrt@denverallergy.com

    Jeffrey Rumbyrt

    Recruiting

  • Wake Forest University Health Sciences- Site Number : 8400003

    Winston-Salem, North Carolina, 27104

    Steven Feldman, 336-716-7740, steven.feldman@advocatehealth.org

    Steven Feldman

    Recruiting

Other trials in United States

China11 sites, 11 recruiting

  • Peking University Third Hospital-Site Number: 1560008

    Beijing, Beijing Municipality, 100191

    Wenhui Wang, +8618618269437, wwh0608@126.com

    Wenhui Wang

    Recruiting

  • Xiangya Hospital of Central South University-Site Number : 1560001

    Changsha, Hu'nan, 410008

    Juan Su, +8615116408921, 540020068@qq.com

    Juan Su

    Recruiting

  • The Second Xiangya Hospital of Central South University-Site Number: 1560014

    Changsha, Hu'nan, 410011

    Yunsheng Liang, +8615973189908, yunshengliang@aliyun.com

    Yunsheng Liang

    Recruiting

  • West China Hospital, Sichuan University- Site Number: 1560003

    Chengdu, Sichuan, 610041

    Jingyi Li, +8618980605704, ljy7733@163.com

    Jingyi Li

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University-Site Number : 1560011

    Chongqing, 400016

    Tao Cai, +8615902305525, caidaodao@hotmail.com

    Tao Cai

    Recruiting

  • Hangzhou First People's Hospital-Site Number: 1560004

    Hangzhou, Zhejiang, 310006

    Liming Wu, +8613750837205, 18957118053@163.com

    Liming Wu

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine-Site Number: 1560007

    Hangzhou, Zhejiang, 310009

    Xiaoyong Man, +8613600516219, manxy@zju.edu.cn

    Xiaoyong Man

    Recruiting

  • The First Affiliated Hospital of Ningbo University-Site Number : 1560009

    Ningbo, Zhejiang, 315010

    Bingjiang Lin, +8617757461212, linbingj@163.com

    Bingjiang Lin

    Recruiting

  • Huashan Hospital, Fudan University-Site Number: 1560012

    Shanghai, 200040

    Wei Li, +8618629352992, liweiderma@fudan.edu.cn

    Wei Li

    Recruiting

  • The Eighth Affiliated Hospital, Sun Yat-sen University-Site Number: 1560006

    Shenzhen, Guangdong, 518033

    Peimei Zhou, +8613880699378, 46551704@qq.com

    Peimei Zhou

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)-Site Number: 1560002

    Xi’an, Shanxi, 710004

    Songmei Geng, +8613060423612, gengsongmei73@163.com

    Songmei Geng

    Recruiting

Other trials in China

France7 sites, 7 recruiting

  • CHU Besançon - Hôpital Jean Minjoz-Site Number: 2500010

    Besançon, Doubs, 25030

    Francois Aubin, +33381218483, faubin@chu-besancon.fr

    Francois Aubin

    Recruiting

  • Centre Hospitalier William Morey-Site Number: 2500008

    Chalon-sur-Saône, Saone Et Loire, 71100

    Marie Dhers, +33385910402, marie.dhers@ch-chalon71.fr

    Marie Dhers

    Recruiting

  • Centre Hospitalier du Mans-Site Number: 2500004

    Le Mans, Sarthe, 72037

    Nathalie Beneton Benhard, +33243434343, nbeneton@ch-lemans.fr

    Nathalie Beneton Benhard

    Recruiting

  • GHRMSA - Hospital Emile Muller-Site Number : 2500006

    Mulhouse, Haut Rhin, 68100

    Catherine Michel, +33389646185, michelc@ghrmsa.fr

    Catherine Michel

    Recruiting

  • Hopitaux Drome Nord-Site Number : 2500002

    Romans-sur-Isère, Rhone, 26102

    Francois Skowron, +33475757575, f.skowron@ch-hdn.fr

    Francois Skowron

    Recruiting

  • CHU de La Reunion-Site Number: 2500007

    Saint-Pierre, Reunion, 97448

    Antoine Bertolotti

    Antoine Bertolotti

    Recruiting

  • Centre Hospitalier de Valence-Site Number: 2500005

    Valence, Drome, 26000

    Anne Grange, +33475757737, aprunier@ch-valence.fr

    Anne Grange

    Recruiting

Other trials in France

Italy4 sites, 4 recruiting

  • Azienda Ospedaliero Universitaria delle Marche-Site Number: 3800009

    Ancona, 60126

    Oriana Simonetti, +390715963494, oriana.simonetti@ospedaliriuniti.marche.it

    Oriana Simonetti

    Recruiting

  • Ospedale Maggiore di Novara-Site Number: 3800005

    Novara, 28100

    Paola Savoia, +393213733387, paola.savoia@med.uniupo.it

    Paola Savoia

    Recruiting

  • Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia-Site Number : 3800006

    Reggio Emilia, 42100

    Vito Di Lernia, +39522296654, vito.dilernia@ausl.re.it

    Vito Di Lernia

    Recruiting

  • Istituto San Gallicano IRCCS - Istituti Fisioterapici Ospitalieri-Site Number: 3800002

    Roma, 00144

    Maria Concetta Fargnoli, +39862368519, mariaconcetta.fargnoli@ifo.it

    Maria Concetta Fargnoli

    Recruiting

Other trials in Italy

United Arab Emirates4 sites, 4 recruiting

  • NMC Specialty Hospital-Site Number : 7840002

    Abu Dhabi, 6222

    Ahmed Ameen, +97126179161, ahmed.ameen@nmc.ae

    Ahmed Ameen

    Recruiting

  • Mediclinic Hospital, AUH-Site Number: 7840004

    Abu Dhabi, 66566

    Hussein Abdel Dayem, +979126139438, habdeldayem@mediclinic.ae

    Hussein Abdel Dayem

    Recruiting

  • Dr Joseph Polyclinic Amber Clinic-Site Number: 7840005

    Al Karama, 50730

    Srikumar Goturu, +96643378828, docsrikumar@gmail.com

    Srikumar Goturu

    Recruiting

  • Dermatology and Aesthetic Center Rashid Hospital-Site Number : 7840003

    Dubai, 00000

    Amani Abdulla Rahma Alfalasi, aaalfalasi@dubaihealth.ae

    Amani Abdulla Rahma Alfalasi

    Recruiting

Other trials in United Arab Emirates

Japan3 sites, 3 recruiting

  • Osaka Habikino Medical Center-Site Number : 3920001

    Habikino-shi, Osaka, 583-8588

    Yoko Kataoka, +81729572121, chiken_jimu@ra.opho.jp

    Yoko Kataoka

    Recruiting

  • JA-Shizuoka Enshu Hospital-Site Number: 3920003

    Hamamatsu, Shizuoka, 430-0929

    Chika Shibuya, +81534531111, chikashibu2@gmail.com

    Chika Shibuya

    Recruiting

  • Takeoka Dermatology Clinic- Site Number : 3920005

    Marugame-shi, Kagawa-ken, 763-0074

    Shintaro Takeoka, +81877251880, takexile1130@gmail.com

    Shintaro Takeoka

    Recruiting

Other trials in Japan

Saudi Arabia3 sites, 3 recruiting

  • Erfan and Bagedo Hospital-Site Number : 6820002

    Jeddah, 21452

    Ahmed Ismail Ebraheem Abdellateef, +96602613888, drahmedismail2006@gmail.com

    Ahmed Ismail Ebraheem Abdellateef

    Recruiting

  • Medical Fakeeh-Site Number : 6820003

    Jeddah, 23421

    Ayman Elgendi, +966507364687, aymanelgendy91@yahoo.com

    Ayman Elgendi

    Recruiting

  • King Fahad Medical City-Site Number : 6820001

    Riyadh, 12231

    Mohammed Alajlan, +96612889999, malajlan@kfmc.med.sa

    Mohammed Alajlan

    Recruiting

Other trials in Saudi Arabia

Spain3 sites, 3 recruiting

  • Hospital General Universitario Dr. Balmis-Site Number: 7240005

    Alicante, 03010

    Juan Francisco Silvestre Salvador, +34965913723, silvestre.jfr@gmail.com

    Juan Francisco Silvestre Salvador

    Recruiting

  • Investigational Site Number : 7240006

    Barcelona, Catalunya [Cataluña], 08041

    Recruiting

  • Hospital Universitario de Canarias-Site Number: 7240008

    Santa Cruz de Tenerife, Tenerife, 38320

    Ruperto Gonzalez Perez, +34922677231, glezruperto@gmail.com

    Ruperto Gonzalez Perez

    Recruiting

Other trials in Spain

Canada1 site, 1 recruiting

  • Origins Dermatology Centre-Site Number : 1240003

    Regina, Saskatchewan, S4V 1R9

    Rachel Asiniwasis, 3065527546, rasiniwasis@gmail.com

    Rachel Asiniwasis

    Recruiting

Other trials in Canada

About this study

Official title: Atopic Dermatitis Disease Registry of Adult and Adolescent Patients Initiating or Switching Systemic Treatments

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.

Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07290803
Study groupRoleWhat they receive
Atopic DermatitisThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Utilizing Atopic Dermatitis (AD) Treatment

    The number (and percentage) of participants taking AD treatments and treatments per patient will be described.

    Measured: Baseline to up to 60 months

  2. Duration of Treatment

    The duration of AD treatments will be summarized descriptively.

    Measured: Baseline to up to 60 months

  3. AD Treatment Sequences

    The ordering of AD treatments will be summarized descriptively.

    Measured: Baseline to up to 60 months

  4. Number of Participants Initiating AD Treatments with Reasons

    The number (and percentage) of patients initiating AD treatment and reasons for initiation will be summarized descriptively.

    Measured: Baseline to up to 60 months

  5. Number of Participants Interrupting AD Treatment

    The number (and percentage) of patients interrupting AD treatment and reasons for treatment interruption will be summarized descriptively.

    Measured: Baseline to up to 60 months

  6. Number of Participants Discontinuing AD Treatment

    The number (and percentage) of patients discontinuing AD treatment and reasons for treatment discontinuation will be summarized descriptively.

    Measured: Baseline to up to 60 months

  7. Number of Participants Switching AD Treatments

    The number (and percentage) of patients switching AD treatment and reasons for treatment switch will be summarized descriptively.

    Measured: Baseline to up to 60 months

  8. Number of Participants Augmenting AD treatment

    The number (and percentage) of patients augmenting AD treatment will be summarized descriptively.

    Measured: Baseline to up to 60 months

  9. Number of Participants Modifying AD Treatment Dose

    The number (and percentage) of patients modifying AD treatment dose, reasons for dose modification, and dosing will be summarized descriptively.

    Measured: Baseline to up to 60 months

  10. Change from Baseline in Extent and Severity of AD Measured with Eczema Area and Severity Index (EASI)

    Clinical outcomes measured using EASI will be summarized at the start of a treatment episode and each follow-up time point.

    Measured: Baseline to up to 60 months

  11. Change from Baseline in Extent and Severity of AD Measured with Body Surface Area (BSA)

    Clinical outcomes measured using BSA will be summarized at the start of a treatment episode and each follow-up time point.

    Measured: Baseline to up to 60 months

  12. Change from Baseline in Extent and Severity of AD Measured with Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD)

    Clinical outcomes measured using vIGA-AD will be summarized at the start of a treatment episode and each follow-up time point.

    Measured: Baseline to up to 60 months

  13. Change from Baseline in Extent and Severity of AD Measured with Revised Investigator's Global Assessment for Atopic Dermatitis (rIGA-AD)

    Clinical outcomes measured using rIGA-AD will be summarized at the start of a treatment episode and each follow-up time point.

    Measured: Baseline to up to 60 months

  14. Change in Atopic Dermatitis Control Test (ADCT) from Baseline

    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.

    Measured: Baseline to up to 60 months

  15. Change in Patient Global Impression of Severity (PGIS) from Baseline

    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.

    Measured: Baseline to up to 60 months

  16. Change in Itch severity as Measured with the Peak Pruritus Numeric Rating Scale (PP-NRS) from Baseline

    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.

    Measured: Baseline to up to 60 months

  17. Change in Skin Pain as Measured with Skin Pain Numeric Rating Scale (SP-NRS) from Baseline

    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.

    Measured: Baseline to up to 60 months

  18. Change in Sleep Disturbance as Measured with Sleep Disturbance Numeric Rating Scale (SD-NRS) from Baseline

    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.

    Measured: Baseline to up to 60 months

  19. Remission of AD

    Total remission of all signs and symptoms of AD will be assessed.

    Measured: Baseline to up to 60 months

Secondary outcomes (16)

  1. Sociodemographic characteristics of Participants

    Demographics characteristics including age, sex, body weight, height, geographic region, education level, employment status, smoking and alcohol status will be collected.

    Measured: Baseline

  2. Ethnic Origin in Combination with Fitzpatrick Scale

    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.

    Measured: Baseline

  3. Disease characteristics of Participants

    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.

    Measured: Baseline

  4. Change from Baseline in Dermatology-specific Quality of Life Measure with Dermatology Life Quality Index (DLQI)

    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).

    Measured: Baseline to up to 60 months

  5. Change from Baseline in Dermatology-specific Quality of Life Measure with Children's Dermatology Life Quality Index (CDLQI)

    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).

    Measured: Baseline to up to 60 months

  6. Change from Baseline in Burden of Assessment Using Patient Health Questionnaire-9 (PHQ-9)

    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".

    Measured: Baseline to up to 60 months

  7. Change from Baseline in AD Specific Work and Classroom Productivity and Impairment Assessed Using WPAI+CIQ

    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.

    Measured: Baseline to up to 60 months

  8. Change from Baseline in Treatment Satisfaction Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM-9)

    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.

    Measured: Baseline to up to 60 months

  9. Visits with Specialty of Attending Healthcare Provider and Reason for Visit

    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.

    Measured: Baseline to up to 60 months

  10. Hospitalizations for AD

    Hospitalization for AD will be assessed.

    Measured: Baseline to up to 60 months

  11. Prevalence of Comorbid Atopic Conditions

    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.

    Measured: Baseline to up to 60 months

  12. Incidence of Comorbid Atopic Conditions

    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.

    Measured: Baseline to up to 60 months

  13. Change from Baseline in Asthma Control Assessed with Asthma Control Questionnaire-5 (ACQ-5)

    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.

    Measured: Baseline to up to 60 months

  14. Occurrence of Concomitant Medication use for AD and Selected Comorbidities

    The occurrence of concomitant medication use for AD and selected comorbidities at baseline and changes (including reason for change) will be summarized.

    Measured: Baseline to up to 60 months

  15. Number of Adverse Events (SAEs)

    Number of patients experiencing AEs.

    Measured: Baseline to up to 60 months

  16. Number of Serious Adverse Events (SAEs)

    Number of patients experiencing SAEs.

    Measured: Baseline to up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start17 Nov 2025
  3. Primary completion30 Jan 2034 (estimated)
  4. Study completion30 Jan 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07290803
Sponsor's protocol ID
OBS18388
Other IDs
U1111-1311-1824
Acronym
ARMADA-AD
Status last verified
Oct 2026
First submitted
28 Nov 2025
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

An observational study of Atopic Dermatitis, run by Sanofi at 82 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, China, France, Italy, United Arab Emirates and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Utilizing Atopic Dermatitis (AD) Treatment (time frame: Baseline to up to 60 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07290803.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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