[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100455727":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":10,"locations":16,"responsibleParty":36,"collaborators":10,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":10,"enrollmentInfo":48,"targetDuration":10,"studyType":51,"phases":10,"briefSummary":52,"conditions":53,"keywords":10,"overallStatus":55,"whyStopped":10,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Participants with moderate to severe atopic dermatitis",null,"Participants initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation.",[13],{"name":14,"affiliation":5,"role":15},"Trial Transparency Clinical Sciences & Operations","STUDY_DIRECTOR",[17,28,32],{"facility":18,"status":10,"city":19,"state":10,"zip":10,"country":20,"countryCode":21,"cosmosGeoPoint":22,"geoPoint":27,"contacts":10},"Investigational site Kuwait","Kuwait City","Kuwait","KW",{"type":23,"coordinates":24},"Point",[25,26],47.97429,29.367,{"lat":26,"lon":25},{"facility":29,"status":10,"city":30,"state":10,"zip":10,"country":30,"countryCode":31,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Investigational site Saudi Arabia","Saudi Arabia","SA",{"facility":33,"status":10,"city":34,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Investigational site United Arab Emirates","United Arab Emirates","AE",{"type":37,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100455727","a-study-to-assess-the-disease-control-of-moderate-to-severe-atopic-dermatitis-in-male-and-female-participants-of-atleast-12-years-old-receiving-dupilumab-injections-in-gulf-countries-100455727",false,"NCT05214326","A Study to Assess the Disease Control of Moderate to Severe Atopic Dermatitis in Male and Female Participants of Atleast 12 Years Old Receiving Dupilumab Injections in Gulf Countries","A Real-World Study to Assess the Disease Control of Moderate to Severe Atopic Dermatitis in Patients Receiving Dupilumab Therapy, With Atopic Dermatitis Control Tool in Gulf Countries","AD-impaCT","Inclusion Criteria:\n\n* Having moderate to severe atopic dermatitis:\n\n  * Moderate atopic dermatitis is defined at screening and baseline as i) Atopic dermatitis body surface area (BSA) involvement ≥10%; and ii) Pruritus numerical rating scale (NRS) ≥3, Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline, Investigator's Global Assessment (IGA)=3, or SCORing Atopic Dermatitis (SCORAD) is between 25 and 50.\n  * Severe atopic dermatitis is defined at screening and baseline as i) Atopic dermatitis BSA involvement ≥10%; ii) Eczema Area and Severity Index (EASI) score ≥20; iii) Investigator's Global Assessment (IGA) score = 4, or SCORAD ≥50.\n* Initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation.\n* Participants and\u002For his legally approved representatives (LAR, in case of minor subject) agrees to sign an informed consent or an assent.\n* Age of 12 years or above.\n\nExclusion Criteria:\n\n* Participation in another trial.\n* Pregnancy or lactating or planning\u002Fintending to be pregnant in the next 6 months.\n* Presence of active chronic or acute infection requiring systemic treatment\n* Diagnosed active endoparasites infection, or suspected high risk of infection.\n* Human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses.\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.","ALL","12 Years",{"count":49,"type":50},187,"ACTUAL","OBSERVATIONAL","Primary objective:\n\nTo assess the disease control of moderate to severe atopic dermatitis in patients aged 12 years and above treated with dupilumab therapy using Atopic Dermatitis Control Tool (ADCT) after 24 weeks of treatment.\n\nSecondary objectives:\n\n* To figure the proportion of patients with reduction of ADCT score by 5 points after 4, 12, and 24 weeks of treatment.\n* To figure the proportion of patients with ADCT score less than 7 at weeks 4, 12, and 24.\n* Assess the effectiveness of dupilumab in moderate to severe atopic dermatitis (AD) patients, using the severity score as routine practice SCORing Atopic Dermatitis (SCORAD).\n* To describe comorbidities related to type 2 inflammation.\n* To characterize the safety profile of dupilumab in the local Gulf population.\n* To evaluate treatment satisfaction in the local Gulf population.",[54],"Dermatitis Atopic","COMPLETED","2023-11-23",{"date":58,"type":50},"2023-11-29",{"date":60,"type":50},"2022-01-18",{"date":62,"type":50},"2023-03-21",{"name":5,"class":6},3]