A Randomized, Double-blinded, Placebo-controlled, Parallel, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of HY209 gel for Patients with Atopic Dermatitis
A composition containing G Protein Coupled Receptor 19(GPCR19) agonist HY209 and a derivative thereof is found to have a considerable effect in the treatment of atopic dermatitis and is proposed as a pharmaceutical ingredient for prevention, treatment and improvement of atopic dermatitis. The GPCR19 agonist, HY209, is superior to conventional steroid ointment and immunosuppressant ointment in the treatment and improvement of allergic dermatitis. It directly reduces the amount of serum immunoglobulin E, which is a major factor of allergic dermatitis, It increases the T helper type 1(TH1) cytokines that alleviate allergic dermatitis pathologies, reduces the T helper type 2(TH2) cytokines that aggravate allergic dermatitis pathologies, and reduces the infiltration of mast cells, eosinophils and neutrophils into the dermal cells. Thus it can be utilized as a therapeutic drug composition for atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
25 subjects will be assigned to drug (HY209 0.3% gel).
25 subjects will be assigned to drug (HY209 0.5% gel).
25 subjects will be assigned to drug (Placebo).
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Hallym University Kangnam Scared Heart Hospital
Seoul, Yeongdeungpo-gu, South Korea
Improvement rate in EASI score
As measured by Eczema Area and Severity Index (EASI)
Time frame: Up to Week 4
Improvement rate in IGA score
As measured by Investigator Global Assessment (IGA)
Time frame: Up to Week 4
Improvement rate Pruritus NRS
As measured by Pruritus Numeric Rating Scale (NRS)
Time frame: Up to Week 4
Change in total IgE
As measured by total Immunoglobin E (IgE)
Time frame: Up to Week 4
Change in Eosinophil count
As measured by Eosinophil count
Time frame: Up to Week 4
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