Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05922176 |
| Other study ID # |
4-2023-0353 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 22, 2023 |
| Est. completion date |
March 31, 2026 |
Study information
| Verified date |
June 2023 |
| Source |
Yonsei University |
| Contact |
Kyung Hee Park |
| Phone |
+82-2-2228-1947 |
| Email |
white182[@]yuhs.ac |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
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.
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.
