Biomarker screening for allergic rhinitis treatment evaluation using a microneedle patch
Biomarker Screening for Immunotherapy Response Evaluation Using Microneedle Patch in Patients with Allergic Rhinitis
This study tests a new skin patch treatment for people with allergic rhinitis from dust mites to see if it works better and is safer than traditional allergy treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 19 Years to 60 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05922176 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a new transdermal immunotherapy method for patients with allergic rhinitis caused by house dust mites. It involves collecting clinical indicators and samples from participants before and after treatment to monitor immune responses. The goal is to improve treatment satisfaction and reduce the risks associated with traditional immunotherapy methods, such as injections and sublingual tablets. Participants will include both patients with allergic rhinitis and healthy controls to compare responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 60 with moderate to severe allergic rhinitis specifically caused by house dust mites.
Not a fit: Patients with allergic rhinitis caused by allergens other than house dust mites or those with significant skin diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more convenient treatment option for patients suffering from allergic rhinitis.
How similar studies have performed: While transdermal immunotherapy is a novel approach, similar studies have shown promise in improving treatment outcomes for allergic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A. patient group of House dust mite 1. 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) 2. Moderate-severe persistent rhinitis when evaluated according to ARIA (Allergic rhinitis and its impact on asthma) 3. 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) <!-- --> 1. 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 2. A person who agrees to provide samples derived from the human body 3. A person who voluntarily agreed to this study and prepared a consent form after approval of the IRB Exclusion Criteria: * A. patient group of House dust mite 1. 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) 2. 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 3. If there is a skin disease or tattoo in the area where the medication is applied 4. Immunosuppressive therapy or systemic steroid therapy for acute and chronic inflammatory skin diseases 5. 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) <!-- --> 1. Patients with allergic diseases such as atopic dermatitis or allergic asthma and rhinitis 2. A person who voluntarily disagrees with this study after approval of the IRB and has not completed the consent form
Where this trial is running
Seoul
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Kyung Hee Park — Yonsei University Health System, Severance Hospital
- Study coordinator: Kyung Hee Park
- Email: white182@yuhs.ac
- Phone: +82-2-2228-1947
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.