Biomarker Screening for Immunotherapy Response Evaluation using Microneedle Patch in Patients with Allergic Rhinitis
- Conditions
- Diseases of the respiratory system
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Based on RNA extracted from skin samples, transcriptomic profiles are analyzed to identify related RNAs that show meaningful changes compared to normal people and immunotherapy using heatmap, and it is estimated that Th2 or Treg-related RNA profiles will be significantly different
- Secondary Outcome Measures
Name Time Method Whether there is a difference in immunological efficacy by type of immunotherapy (subcutaneous, sublingual, percutaneous) is confirmed through pre- and post-group comparisons.