RecruitingNCT05922176

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

Sponsor

Yonsei University

Enrollment

30 participants

Start Date

May 22, 2023

Study Type

OBSERVATIONAL

Conditions

Rhinitis, Allergic

Summary

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.

Eligibility

Min Age: 19 YearsMax Age: 60 Years

Inclusion Criteria8

A. patient group of House dust mite
Adult male and female patients aged 19 to 60 with allergic rhinitis caused by the antigen of the American house dust mite (It is judged that the positive for the house dust mite is MAST ≥ Class 3 or ImmunoCAP® ≥3.5 kUA/L)
Moderate-severe persistent rhinitis when evaluated according to ARIA (Allergic rhinitis and its impact on asthma)
A person who has signed a written consent to participate in this clinical trial at his/her own discretion after fully explaining the purpose, contents, characteristics of the test drug, and expected adverse reactions prior to participation in the clinical trial B. Control group (Normal person)
Adults 19 years of age or older who are judged to be free from skin diseases or allergic diseases through medical examination and visual observation by a specialist
A person who agrees to provide samples derived from the human body
A person who voluntarily agreed to this study and prepared a consent form after approval of the IRB

Exclusion Criteria9

A. patient group of House dust mite
Patients who are taking drugs that may affect efficacy evaluation (but can participate if there is no change in the drug taken during the study period)
Within six months of participation in the study, other clinical trial drugs or biological equivalence test drugs, biological agents (e.g. Anti-IgE) were administered
If there is a skin disease or tattoo in the area where the medication is applied
Immunosuppressive therapy or systemic steroid therapy for acute and chronic inflammatory skin diseases
A person in charge of testing or a person in charge of testing deemed inappropriate to participate in the test due to other reasons B. Control (Normal person)
Patients with allergic diseases such as atopic dermatitis or allergic asthma and rhinitis
A person who voluntarily disagrees with this study after approval of the IRB and has not completed the consent form

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Interventions

OTHEREvaluation of clinical indicators, Sample collection before& after immunotherapy

A. Evaluation of clinical indicators before immunotherapy 1. Symptom Scale for Rhinitis: Total Nasal Symptom Score (TNSS), Rhnitis Quality of Life Questionnaire(RQLQ) 2. American house dust mite-specific immunogloblin G4 (sIgG4) 3. American house dust mite-specific immunogloblin E (sIgE) B. Sample collection before immunotherapy 1. Skin: Skin test using minimally invasive microstructure patch stripping method 2. Blood: Measurement of blood immunological indicators (Th2, Treg-related cytokine and blocking factor, etc.) C. Evaluation of clinical indicators 4 to 6 months after immunotherapy : Treatment is performed for about 4 months, and the progress of treatment is evaluated through the evaluation of the following clinical indicators. same as examination in 'A' D. Sample collection after 4 to 6 months of immunotherapy same as examination in 'B'

OTHERSample collection before& after immunotherapy

B. Sample collection before immunotherapy 1. Skin: Skin test using minimally invasive microstructure patch stripping method 2. Blood: Measurement of blood immunological indicators (Th2, Treg-related cytokine and blocking factor, etc.) D. Sample collection after 4 to 6 months of immunotherapy 1. Skin: Skin test using minimally invasive microstructure patch stripping method 2. Blood: Measurement of blood immunological indicators (Th2, Treg-related cytokine and blocking factor, etc.)