Actively Recruiting

Age: 19Years - 60Years
All Genders
Healthy Volunteers
NCT05922176

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

149 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

Allergic rhinitis is a disease in which the nasal mucous membrane overreacts to allergens, resulting in symptoms such as spasmodic and repetitive sneezing, rhinorrhea, and stuffy nose, and can be treated with immunotherapy for radical treatment. Immunotherapy treatments include subcutaneous injections, sublingual tablets, and sublingual fluids, and subcutaneous injections have the risk of anaphylaxis, the hassle of daily administration at home, and local allergic reactions. Transdermal absorption immunotherapy (DF19001) that can compensate for the shortcomings of these existing immunotherapy drugs is currently under clinical research in Korea (Severance Hospital IRB No. 4-2021-1345). Immunotherapy requires periodic monitoring, such as analyzing immunological changes through sample collection and determining the dose and cycle of administration, because the treatment period is long and individual immune responses are different. Existing methods for confirming immune responses in samples used invasive skin biopsy and blood collection methods, but in-blood evaluation indicators have the disadvantage of being ineffective as initial efficacy evaluations or predictive evaluations before treatment. In addition, skin biopsy should be performed by a specialist, and there is a disadvantage that resistance occurs because the patient's pain is accompanied, and scars or bruises may remain. Therefore, since it is a biopsy through minimal invasion compared to a tissue biopsy, the investigators would like to use a method of collecting skin samples through a microstructure (micro needle patch), a method that has little pain and no scars. Through this study, RNA is obtained from patients with house dust mite allergic rhinitis through minimally invasive skin samples, and immunotherapy response evaluation biomarkers are screened according to immunotherapy implementation, and its use as an indicator of immunotherapy prognosis in allergic diseases.

CONDITIONS

Official Title

Biomarker Screening for Immunotherapy Response Evaluation Using Microneedle Patch in Patients with Allergic Rhinitis

Who Can Participate

Age: 19Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 19 to 60 with allergic rhinitis caused by American house dust mite (positive MAST ≥ Class 3 or ImmunoCAP® ≥3.5 kUA/L)
  • Moderate to severe persistent rhinitis according to ARIA evaluation
  • Signed informed consent after full explanation of study purpose and treatments
  • Control group: adults 19 or older without skin or allergic diseases, agreeing to provide samples and consent
Not Eligible

You will not qualify if you...

  • Taking drugs that may affect efficacy evaluation unless dosage is stable during study
  • Use of clinical trial drugs, biological agents, or anti-IgE within 6 months before participation
  • Skin disease or tattoos at patch application site
  • Receiving immunosuppressive or systemic steroid therapy for inflammatory skin diseases
  • Any other reason deemed by investigators as unsuitable for participation
  • Control group: presence of allergic diseases like atopic dermatitis, allergic asthma, or rhinitis
  • Declined or did not complete informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Yonsei University Health System, Severance Hospital

Seoul, South Korea, 03722

Actively Recruiting

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Research Team

K

Kyung Hee Park

CONTACT

I

Im Shin

CONTACT

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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