Biomarker Screening for Immunotherapy Response Evaluation Using Microneedle Patch in Patients With Allergic Rhinitis — MIST  

Rhinitis, Allergic Clinical Trial

Official title: Biomarker Screening for Immunotherapy Response Evaluation Using Microneedle Patch in Patients With Allergic Rhinitis

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Allergic rhinitis is a disease in which the nasal mucosa overreacts to allergens, resulting in symptoms such as seizure and repetitive sneezing, runny nose, and stuffy nose. Typical treatments include avoiding causative substances and anti-allergic medication. Immunotherapy may not be sufficient for treatment satisfaction with existing treatments, it is practically impossible to avoid allergens, or allergen specific immunotherapy may be performed for more root treatment.

Immunotherapy is known as the only way to change the natural course of allergic diseases by increasing the amount of substances that cause allergic reactions to allergic patients from a small amount and reducing allergic reactions through repeated administration for three to five years. Immunotherapy treatments include hypodermic injections, hypodermic tablets, and hypodermic fluids, and each has its pros and cons. Subcutaneous injection immunotherapy requires regular visits to a medical institution for injection, and there is a risk of anaphylaxis. Although sublingual immunotherapy has a low risk of anaphylaxis, it is cumbersome to administer it daily at home, and the incidence of local allergic reactions in the oral cavity is high due to 30 to 70 times less absorption in the body than injection treatments. Transdermal absorption immunotherapy (DF19001) that can compensate for the shortcomings of these existing immunotherapy drugs is currently under clinical research in Korea (Serbans Hospital IRB No. 4-2021-1345).

These immunotherapy require periodic monitoring, such as analyzing immunological changes through sample collection and determining administration dose and cycle, because the treatment period is long at 3-5 years and individual immune responses are different. Most of the existing methods for confirming immune responses in samples used invasive skin biopsy or blood collection methods, but allergen specific IgE (allergen specific IgG4, blocking factors) have the disadvantage of being ineffective as an initial efficacy evaluation or a pre-treatment prediction evaluation of a subject. In addition, various analysis methods can be used through skin biopsy to see changes in the initial immune response of the inoculation site, but this must be performed by a specialist, and has the disadvantage of being resistant to patient pain and scarring or bruising.

Therefore, in order to overcome these difficulties through this clinical study, the investigators would like to use a method of collecting skin samples through a microstructure (micro needle patch). When the microstructure patch is applied to the skin surface for 5 minutes, it passes through the microstructure's fine needle (<0.5 mm long) keratin layer and enters the inside of the skin as shown in the image below. Various immunological indicators are analyzed by collecting skin factors remaining in the patch by applying the patch for a sufficient time for various factors in the epidermis and dermis layer to be adsorbed through the microstructure that has entered the skin.

Since this method is a biopsy through minimal invasion compared to conventional tissue biopsy, there is little pain and no scarring, and previous studies have confirmed that a small amount of RNA can be separated from skin samples using microstructure patches and microarray can be performed. In addition, in the same way, the detection of protein biomarkers according to the test collection method for determining treatment in patients with atopic dermatitis was observed.

Therefore, this study aims to obtain RNA from patients with house dust mite allergic rhinitis through minimally invasive skin samples, screen the biomarker for immunotherapy response evaluation through immunotherapy and confirm its use as an indicator of immunotherapy prognosis in allergic diseases. ;

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic

• NCT number: NCT05922176
• Study type: Observational
• Source: Yonsei University
• Contact: Kyung Hee Park
• Phone: +82-2-2228-1947
• Email: white182@yuhs.ac
• Status: Recruiting
• Start date: May 22, 2023
• Completion date: March 31, 2026