Status:
COMPLETED
Dupilumab and House Dust Mite Immunotherapy in Patients With Atopic Dermatitis
Lead Sponsor:
Medical University of Silesia
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Severe atopic dermatitis (AD) is a complex disease requiring systemic treatment. This study aimed to assess the effectiveness of combined therapy consisting of dupilumab and sublingual dust mite aller...
Detailed Description
Study design This randomized, 12-month trial has performed in the Clinical Outpatient Allergy Department and six other outpatient cities. All included patients has received SLIT to HDM and/or dupiluma...
Eligibility Criteria
Inclusion
- diagnosed with AD a minimum of one year before the study (documented one year of therapy for AD)
- between 18 and 45 years of age
- severe AD with an Eczema Area and Severity Index (EASI) \>20 points, a %BSA (body surface area) \>10 points, an IsGA (Investigator Global Assessment) = 4 points, a positive skin prick test (SPT)
- a positive result for specific immunoglobulin E (sIgE) to extracts of D. pteronyssinus and D. farinae and to Der p 1;
- negative results for SPT and sIgE to other inhalant allergens;
- no symptoms of allergic asthma and/or allergic rhinitis
Exclusion
- other active dermatoses, systemic immunosuppressant treatment up to 7 months before the study, other chronic diseases,
- contraindications to sublingual immunotherapy or dupilumab,
- lack of written consent
Key Trial Info
Start Date :
February 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2024
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06509243
Start Date
February 10 2023
End Date
April 10 2024
Last Update
July 19 2024
Active Locations (1)
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1
SUM
Zabrze, Poland