NCT00310492CompletedPhase 3
Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study to Demonstrate the Efficacy of a 12-month Subcutaneous Specific Immunotherapy With ALK-depot SQ Milbenmischung in Patients With Atopic Dermatitis and Proven IgE-mediated Sensitization to House Dust Mites
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- ALK-Abelló A/S
- Enrollment
- 154
- Locations
- 2
- Primary Endpoint
- Changes from baseline in SCORAD and topical medication consumption
Study Overview
Brief Summary
This trial is performed to assess the efficacy and safety of ALK-depot SQ mites for treatment of atopic dermatitis
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Positive specific IgE to house dust mites
- •Atopic dermatitis according to Hanifin/Rajka
- •Chronic course of Atopic dermatitis
- •SCORAD larger than 25 points
Exclusion Criteria
- •Erythrodermia
- •Syst.treatment with gcs or immunosuppressive agents in the prev.4 weeks
- •History of specific immunotherapy with mites
- •UV radiation
- •Group 4 topical corticosteroids (European classification)
Arms & Interventions
Subcutaneous immunotherapy
Active Comparator
Subcutaneous injections with ALK-depot SQ mites to 100,000 SQ-U
Intervention: subcutaneous immunotherapy (Biological)
Subcutaneous injections
Placebo Comparator
placebo injections
Intervention: subcutaneous immunotherapy (Biological)
Outcomes
Primary Outcomes
Changes from baseline in SCORAD and topical medication consumption
Time Frame: 1 year
Sccore of atopic dermatitis (SCORAD)
Secondary Outcomes
- Changes from baseline in SCORAD intensity score, EASI score and change in topical medication consumption(1 year)
Investigators
Study Sites (2)
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