Actively Recruiting
Biomarker Screening for Immunotherapy Response Evaluation Using Microneedle Patch in Patients with Allergic Rhinitis
Led by Yonsei University · Updated on 2025-03-11
30
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
Sponsors
Y
Yonsei University
Lead Sponsor
K
Korea Health Industry Development Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying allergic rhinitis, a condition where the nasal lining overreacts to allergens like house dust mites, causing symptoms such as sneezing, runny nose, and congestion. This research focuses on improving immunotherapy, a treatment that aims to change the course of allergic diseases by gradually increasing tolerance to allergens. The study also explores a new method using a microneedle patch to collect skin samples with minimal pain, aiming to identify biomarkers that predict and evaluate response to immunotherapy. Participants include adults aged 19 to 60 with moderate to severe allergic rhinitis caused by house dust mites and a control group without allergic or skin diseases. The study involves evaluating clinical indicators and collecting skin and blood samples before and 4 to 6 months after immunotherapy. The microneedle patch collects skin factors painlessly by penetrating the skin's outer layer for 5 minutes. Immunotherapy types studied include subcutaneous injections, sublingual tablets, and percutaneous treatments. Participants will undergo symptom evaluations using questionnaires and immunological tests before and after about 4 months of treatment. Blood and skin samples are collected to analyze immune responses using RNA transcriptomic profiling and other markers. Researchers monitor changes in immune indicators and compare responses across different immunotherapy types. The total observation period includes baseline and follow-up assessments 4 to 6 months later, with safety and efficacy monitored throughout.
CONDITIONS
Brief Title
Biomarker Screening for Immunotherapy Response Evaluation Using Microneedle Patch in Patients with Allergic Rhinitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 to 60 with allergic rhinitis caused by American house dust mite confirmed by allergy tests (MAST ≥ Class 3 or ImmunoCAP® ≥3.5 kUA/L)
- Moderate to severe persistent rhinitis according to ARIA guidelines
- Signed written consent after understanding the study purpose and procedures
- Adults 19 years or older without skin or allergic diseases for control group
- Consent to provide human-derived samples and voluntary agreement to participate
You will not qualify if you...
- Taking drugs that may affect efficacy evaluation unless stable during the study
- Use of other clinical trial drugs, biologics, or biological equivalence test drugs within six months
- Presence of skin disease or tattoo at the patch application site
- Receiving immunosuppressive or systemic steroid therapy for inflammatory skin diseases
- Allergic diseases such as atopic dermatitis, allergic asthma, or rhinitis in control group
- Voluntary refusal or incomplete consent after IRB approval
- Any other reasons deemed inappropriate for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo evaluation of clinical indicators and sample collection before immunotherapy to assess baseline immune responses.
1 visit (in-person)
Duration - 4 to 6 months
Participants receive immunotherapy for about 4 months with follow-up evaluation of clinical indicators and sample collection to monitor immunological changes and treatment response.
1 visit before and 1 visit after immunotherapy
Trial Site Locations
Total: 1 location
1
Yonsei University Health System, Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
Research Team
K
Kyung Hee Park
I
Im Shin
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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