NCT06509243Completed
Dupilumab and House Dust Mite Immunotherapy in Patients With Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 19 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 132 (actual)
- First submitted
- 5 Jun 2024
- Start date
- 10 Feb 2023
- Primary completion date
- 12 Mar 2024
- Lead sponsor
- Medical University of Silesia
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06509243
What you commit to
- Study type: Interventional
- Participants enrolled: 132
- From 10 Feb 2023 to the primary completion date, 12 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- other active dermatoses, systemic immunosuppressant treatment up to 7 months before the study, other chronic diseases,
- contraindications to sublingual immunotherapy or dupilumab,
Other
- lack of written consent
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SUM Coordinator of this site? Confirm its status | Zabrze | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.