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

NCT04530643 | Completed Phase 2

• 1 other identifier: HY209-Gel
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Improvement rate in EASI score

  As measured by Eczema Area and Severity Index (EASI)

  Up to Week 4

Secondary Outcomes (4)

• Improvement rate in IGA score

  Up to Week 4

• Improvement rate Pruritus NRS

  Up to Week 4

• Change in total IgE

  Up to Week 4

• Change in Eosinophil count

  Up to Week 4

Study Arms (3)

HY209 0.3%

EXPERIMENTAL

multiple dose of HY209 0.3% gel

Drug: HY209 0.3%

HY209 0.5%

EXPERIMENTAL

multiple dose of HY209 0.5% gel

Drug: HY209 0.5%

Placebo

PLACEBO COMPARATOR

multiple dose of Placebo

Drug: Placebo

Interventions

HY209 0.3% DRUG

25 subjects will be assigned to drug (HY209 0.3% gel).

Also known as: HY209 gel

HY209 0.3%

HY209 0.5% DRUG

25 subjects will be assigned to drug (HY209 0.5% gel).

Also known as: HY209 gel

HY209 0.5%

Placebo DRUG

25 subjects will be assigned to drug (Placebo).

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 19 Years and older, Male or female
• Those who have a clinical diagnosis of atopic dermatitis according to the criteria of Hanifin and Rajka
• IGA of 2 or 3 at Baseline Visit
• BSA covered with AD of at least 5% and no more than 40% at Baseline Visit
• Those who must be capable of giving informed consent and willing to comply with all clinic visits and study-related procedures until study completion

You may not qualify if:

• Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Taurodeoxycholate , aspirin, antibiotics, etc.)
• Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic diseases, mental diseases, especially hemorrhagic diseases (hemophilia, von Willebrand disease, etc.), cardiovascular diseases (coronary artery diseases, congestive heart failure, arrhythmia, cerebrovascular diseases, etc.) or who have a history of those diseases
• Those who have systemic infection at Screening Visit
• Those who have asthma at Screening Visit
• Treatment with steroids, oral antibiotics, body photochemotherapy, immunosuppressive drug within 4 weeks before the Baseline Visit (Day 1)
• Treatment with topical steroids, antibiotics within 2 weeks before the Baseline Visit (Day 1)
• Those who have taken a prohibited concomitant medication
• Those who have Creatinine values more than two times of the upper limit of normal range at screening test
• Those who have AST/ALT values more than two times of the upper limit of normal range at screening test
• Those who have been taking medicines by participating in other clinical trials or bioequivalence studies within 6 months prior to the date of first administering (the time from the date of participation in the previous clinical trial is based on the date of administration of each applicable study drug. However, if the half-life of the study drug taken in a previously participated clinical trial is 2 weeks or more, 5 times the expected half-life of the study drug)
• Those who have history of HIV infection or HIV seropositivity at Screening Visit
• Those who are positive or undeterminable in serological tests (HBsAg, HBcAb, or Hepatitis C virus antibody, Hepatitis B virus antibody) at Screening Visit
• Those who have skin diseases or conditions affecting skin that may interfere with clinical trial evaluation (acne, impetigo, chicken pox, active herpes simplex at Baseline, corticosteroid induced perioral dermatitis, tinea corporis/intertriginous, head lice or scabies)
• Those who have had malignant tumor within 5 years prior to Baseline Visit
• Atopic Dermatitis treatment with topical drug (containing ceramide, hyaluronic acid, urea or filaggrin) during Screening period

Sponsors & Collaborators

• Shaperon: lead

Study Sites (3)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Hallym University Kangnam Scared Heart Hospital

Seoul, Yeongdeungpo-gu, 07441, South Korea

Location

Related Publications (1)

• Baek GH, Kim BR, Shin JW, Huh CH, Hwang J, Ko S, Kim S, Ho PS, Kim KH, Park CW, Seo SJ, Park CO, Shin D, Kim Y, Kim Y, Seong SY, Na JI. A phase 2a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy and safety of NuGel, a novel topical GPCR19-mediated inflammasome inhibitor, in patients with mild to moderate atopic dermatitis: a proof-of-concept study with Post-hoc biomarker analysis. Front Immunol. 2025 May 19;16:1560447. doi: 10.3389/fimmu.2025.1560447. eCollection 2025.

  PMID: 40458407 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: August 26, 2020
• Primary Completion: September 7, 2021
• Study Completion: September 7, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Locations

KR (3)