NCT05922176: MIST

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

Recruiting now Last updated 11 March 2025

What this trial tests

trial testing Evaluation of clinical indicators, Sample collection before& after immunotherapy in Rhinitis, Allergic in 30 participants. Currently enrolling.

Timeline

22 May 2023

Primary endpoint
7 February 2025

31 March 2026

Quick facts

Lead sponsor	Yonsei University
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	30
Start date	22 May 2023
Primary completion	7 February 2025
Estimated completion	31 March 2026
Sites	1 location across South Korea

Drugs / interventions tested

• Evaluation of clinical indicators, Sample collection before& after immunotherapy
• Sample collection before& after immunotherapy

Conditions studied

• Rhinitis, Allergic — all drugs for Rhinitis, Allergic →

Sponsor

Yonsei University

Who can join

Adults 19 to 60, any sex, with Rhinitis, Allergic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microneedle Sensors for Point-of-Care Diagnostics.
   Hu Y, Chatzilakou E, Pan Z, Traverso G, et al · · 2024 · cited 67× · PMID 38225744 · DOI 10.1002/advs.202306560
2. Polymeric Microneedles for Health Care Monitoring: An Emerging Trend.
   Pereira RL, Vinayakumar KB, Sillankorva S. · · 2024 · cited 23× · PMID 38654679 · DOI 10.1021/acssensors.4c00612
3. From mechanism to applications: Advanced microneedles for clinical medicine.
   Yang Y, Sun H, Sun X, Wang Y, et al · · 2025 · cited 9× · PMID 40463395 · DOI 10.1016/j.bioactmat.2025.04.025
4. Microneedle delivery systems for vaccines and immunotherapy.
   Jia H, Liu J, Shi M, Abbas M, et al · · 2025 · cited 4× · PMID 41035520 · DOI 10.1002/smo.20240067
5. Body Biofluids for Minimally-Invasive Diagnostics: Insights, Challenges, Emerging Technologies, and Clinical Potential.
   Rao LT, Mandal CK, Patolsky F. · · 2026 · cited 1× · PMID 41074254 · DOI 10.1002/adhm.202503096