CompletedNot Applicable

Dupilumab and House Dust Mite Immunotherapy in Patients With Atopic Dermatitis

Poland132 participantsStarted 2023-02-10

Plain-language 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 allergen immunotherapy (SLIT-HDM) in patients with severe AD and HDM allergies. Methods: Patients diagnosed with severe AD were included in a randomized, placebo-controlled, double-blind 12-month trial; they received SLIT to HDM and/or dupilumab for 12 months and were compared to patients on cyclosporine. EASI, %BSA, and IsGA changes were analyzed in the different treatment arms from the beginning to the end of the 12th month. The secondary outcomes were the proportion of patients who achieved IsGA success and reduced medication scores.

Who can participate

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Changes in EASI (the Eczema Area and Severity Index) scale

Timeframe: 12 months

Changes in BSA% (Body Surface Area) scale

Timeframe: 12 months

Changes in IsGA (investigator global assessment) scale

Timeframe: 12 months

Trial details

NCT IDNCT06509243

SponsorMedical University of Silesia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-12

View on ClinicalTrials.gov More Atopic Dermatitis trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.