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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1311-1824 | Registry Identifier | ICTRP |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Utilizing Atopic Dermatitis (AD) Treatment | 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 | The duration of AD treatments will be summarized descriptively. | Baseline to up to 60 months |
| AD Treatment Sequences | The ordering of AD treatments will be summarized descriptively. | Baseline to up to 60 months |
| 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. | Baseline to up to 60 months |
| Number of Participants Interrupting AD Treatment | 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 | 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 | The number (and percentage) of patients switching AD treatment and reasons for treatment switch will be summarized descriptively. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Ethnic Origin in Combination with Fitzpatrick Scale |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | Contact-US@sanofi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Dermatology & Skin Health Center- Site Number : 8400006 | Recruiting | Birmingham | Alabama | 35244 | United States |
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
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| Baseline to up to 60 months |
| Number of Participants Augmenting AD treatment | 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 | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | Total remission of all signs and symptoms of AD will be assessed. | Baseline to up to 60 months |
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 | 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) | 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) | 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) | 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 | 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) | 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 | 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 | Hospitalization for AD will be assessed. | Baseline to up to 60 months |
| 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. | Baseline to up to 60 months |
| 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. | Baseline to up to 60 months |
| 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. | Baseline to up to 60 months |
| 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. | Baseline to up to 60 months |
| Number of Adverse Events (SAEs) | Number of patients experiencing AEs. | Baseline to up to 60 months |
| Number of Serious Adverse Events (SAEs) | Number of patients experiencing SAEs. | Baseline to up to 60 months |
| River Region Dermatology and Laser- Site Number : 8400041 | Recruiting | Montgomery | Alabama | 36117 | United States |
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| San Tan Allergy & Asthma- Site Number : 8400031 | Recruiting | Gilbert | Arizona | 85234 | United States |
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| Kern Research, Inc.- Site Number : 8400047 | Recruiting | Bakersfield | California | 93301 | United States |
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| Center for Dermatology Clinical Research- Site Number : 8400014 | Recruiting | Fremont | California | 94538 | United States |
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| Dermatology Research Associates - Los Angeles- Site Number : 8400020 | Recruiting | Los Angeles | California | 90045 | United States |
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| Northridge Clinical Trials, LLC- Site Number : 8400009 | Recruiting | Northridge | California | 91325 | United States |
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| Sunwise Clinical Research, LLC.- Site Number : 8400010 | Recruiting | Oakland | California | 94596 | United States |
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| Empire Clinical Research, LLC- Site Number : 8400007 | Recruiting | Pomona | California | 91767 | United States |
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| University Clinical Trials- Site Number : 8400019 | Recruiting | San Diego | California | 92123 | United States |
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| Western States Clinical Research, Inc.- Site Number : 8400051 | Recruiting | Wheat Ridge | Colorado | 80033 | United States |
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| St. Jude Clinical Research- Site Number : 8400049 | Recruiting | Doral | Florida | 33172 | United States |
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| Ziaderm Research, LLC- Site Number : 8400021 | Recruiting | North Miami Beach | Florida | 33162-4708 | United States |
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| Skin Care Physicians of Georgia - Macon- Site Number : 8400034 | Recruiting | Macon | Georgia | 31217 | United States |
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| Sneeze, Wheeze, & Itch Associates, LLC- Site Number : 8400029 | Recruiting | Normal | Illinois | 61761 | United States |
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| Rosalind Franklin University of Medicine and Science- Site Number: 8400056 | Recruiting | North Chicago | Illinois | 60064 | United States |
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| David Fivenson, MD, Dermatology, PLLC- Site Number : 8400017 | Recruiting | Ann Arbor | Michigan | 48103 | United States |
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| Oakland Hills Dermatology- Site Number : 8400042 | Recruiting | Auburn Hills | Michigan | 48326 | United States |
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| Great Lakes Research Group - Bay City- Site Number : 8400052 | Recruiting | Bay City | Michigan | 48706 | United States |
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| The Derm Institute of West Michigan- Site Number : 8400025 | Recruiting | Caledonia | Michigan | 49316 | United States |
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| Michigan Dermatology Institute - Waterford- Site Number : 8400013 | Recruiting | Waterford | Michigan | 48328 | United States |
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| Red River Research Partners, Llc- Site Number : 8400054 | Recruiting | Bolivar | Missouri | 65613 | United States |
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| Cleaver Dermatology- Site Number : 8400033 | Recruiting | Kirksville | Missouri | 63501 | United States |
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| Allergy Asthma & Immunology- Site Number : 8400044 | Recruiting | Lincoln | Nebraska | 68510 | United States |
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| Las Vegas Dermatology- Site Number : 8400002 | Recruiting | Las Vegas | Nevada | 89144 | United States |
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| Optima Research Portsmouth- Site Number : 8400032 | Recruiting | Portsmouth | New Hampshire | 03801 | United States |
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| University Of New Mexico School Of Medicine- Site Number : 8400022 | Recruiting | Albuquerque | New Mexico | 87102 | United States |
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| Piedmont Plastic Surgery and Dermatology- Site Number : 8400038 | Recruiting | Huntersville | North Carolina | 28078 | United States |
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| Wake Forest University Health Sciences- Site Number : 8400003 | Recruiting | Winston-Salem | North Carolina | 27104 | United States |
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| Red River Research Partners - Fargo- Site Number : 8400037 | Recruiting | Fargo | North Dakota | 58103 | United States |
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| Dermatologists of Southwest Ohio - Mason- Site Number : 8400050 | Recruiting | Mason | Ohio | 45040 | United States |
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| UPMC - Department of Dermatology- Site Number : 8400024 | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| Care Access Research - Warwick 2- Site Number : 8400045 | Recruiting | Warwick | Rhode Island | 02886 | United States |
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| Advanced Dermatology and Cosmetic Surgery - Spartanburg- Site Number : 8400004 | Recruiting | Spartanburg | South Carolina | 29307 | United States |
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| Reveal Research Institute - Dallas- Site Number : 8400012 | Recruiting | Dallas | Texas | 75235 | United States |
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| Innovate Research - Fort Worth- Site Number : 8400016 | Recruiting | Fort Worth | Texas | 76244 | United States |
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| Austin Institute for Clinical Research, Inc- Site Number : 8400030 | Recruiting | Pflugerville | Texas | 78660 | United States |
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| Complete Dermatology - Sugar Land- Site Number : 8400001 | Recruiting | Sugar Land | Texas | 77479 | United States |
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| Cope Family Medicine-Site Number : 8400053 | Recruiting | Bountiful | Utah | 84010-8917 | United States |
| Springville Dermatology - Springville- Site Number : 8400055 | Recruiting | Springville | Utah | 84663 | United States |
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| Fuchs Dermatology- Site Number : 8400027 | Recruiting | Falls Church | Virginia | 22042 | United States |
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| Frontier Dermatology Partners CRO LLC- Site Number : 8400011 | Recruiting | Mill Creek | Washington | 98012 | United States |
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| University of Washington - Roosevelt Location- Site Number : 8400005 | Recruiting | Seattle | Washington | 98105 | United States |
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| Origins Dermatology Centre-Site Number : 1240003 | Recruiting | Regina | Saskatchewan | S4V 1R9 | Canada |
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| The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)-Site Number: 1560002 | Recruiting | Xi’an | Shanxi | 710004 | China |
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| The First Affiliated Hospital of Ningbo University-Site Number : 1560009 | Recruiting | Ningbo | Zhejiang | 315010 | China |
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| The First Affiliated Hospital of Chongqing Medical University-Site Number : 1560011 | Recruiting | Chongqing | 400016 | China |
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| Huashan Hospital, Fudan University-Site Number: 1560012 | Recruiting | Shanghai | 200040 | China |
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| Centre Hospitalier de Valence-Site Number: 2500005 | Recruiting | Valence | Drome | 26000 | France |
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| GHRMSA - Hospital Emile Muller-Site Number : 2500006 | Recruiting | Mulhouse | Haut Rhin | 68100 | France |
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| Hopitaux Drome Nord-Site Number : 2500002 | Recruiting | Romans-sur-Isère | Rhone | 26102 | France |
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| Azienda Ospedaliero Universitaria delle Marche-Site Number: 3800009 | Recruiting | Ancona | 60126 | Italy |
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| Ospedale Maggiore di Novara-Site Number: 3800005 | Recruiting | Novara | 28100 | Italy |
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| Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia-Site Number : 3800006 | Recruiting | Reggio Emilia | 42100 | Italy |
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| Takeoka Dermatology Clinic- Site Number : 3920005 | Recruiting | Marugame-shi | Kagawa-ken | 763-0074 | Japan |
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| Osaka Habikino Medical Center-Site Number : 3920001 | Recruiting | Habikino-shi | Osaka | 583-8588 | Japan |
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| King Saud University-Site Number: 6820004 | Recruiting | Riyadh | 11472 | Saudi Arabia |
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| King Fahad Medical City-Site Number : 6820001 | Recruiting | Riyadh | 12231 | Saudi Arabia |
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| Dr Joseph Polyclinic Amber Clinic-Site Number: 7840005 | Recruiting | Al Karama | 50730 | United Arab Emirates |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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