NCT04530643

A Phase II Study of HY209 Gel for Atopic Dermatitis Patients (Shaperon)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Shaperon · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	HY209 0.3%	25 subjects will be assigned to drug (HY209 0.3% gel).
DRUG	HY209 0.5%	25 subjects will be assigned to drug (HY209 0.5% gel).
DRUG	Placebo	25 subjects will be assigned to drug (Placebo).

Timeline

• Start date: 2020-08-26
• Primary completion: 2021-09-07
• Completion: 2021-09-07
• First posted: 2020-08-28
• Last updated: 2022-01-28

Locations

3 sites across 1 country: South Korea