💬In plain words
What the trial is, and whether it could suit you
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 i
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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)
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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)
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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
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