Phase 2 Trial of HY209gel in Atopic Dermatitis Patients

NCT06024499 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HY209-AD-02
• Study Type: interventional
• Target: 210
• Locations: 2 countries
• Sites: 12

Brief Summary

This is a randomized, double-blind, placebo-controlled, multi-center, phase 2 study in patients with mild to moderate Atopic Dermatitis(AD), which consists of 2 parts.

Conditions

Atopic Dermatitis; Atopic Dermatitis Eczema; Atopic Dermatitis of Scalp

Outcome Measures

Primary Outcomes (1)

• Percentage change in Eczema Area and Severity Index (EASI) score

  To achieve lower score means disease improvement .

  at Week 8

Study Arms (3)

PART 2 High-Dose

ACTIVE COMPARATOR

Active group selected for PART1 as a high-dose

Drug: HY209GEL Active

PART 2 Low-Dose

ACTIVE COMPARATOR

Active group selected for PART1 as a Low-dose

Drug: HY209GEL Active

PART 2 Placebo

PLACEBO COMPARATOR

Placebo group

Other: Placebo

Interventions

HY209GEL Active DRUG

Selected two among four doses (HY209GEL 0.5% or 1% or 2% or 4%) in PART1

PART 2 High-Dose; PART 2 Low-Dose

Placebo OTHER

Placebo

PART 2 Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 18 or older
• Subjects who have a history of AD at least 6 months ago from screening and have been clinically stable for ≥ 1 month
• Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist
• Subjects who have a minimum of 5% and a maximum of 30% of total body surface area (BSA) affected by AD at screening and baseline visits
• Subjects with vIGA score 2 or 3 corresponding to mild to moderate AD at screening and baseline visit
• Subjects should be a literate person who can read the participant information sheet and consent form/questionnaire and understand the language of the participation

You may not qualify if:

• Subjects who have unstable AD (i.e., remaining clinical stable less than 6 months) or any consistent requirement for any potency topical corticosteroids
• Subjects who have topical treatment with corticosteroids within 2 weeks prior to baseline visit or other topical treatments of the AD area at screening (moisturizers/emollients are allowed)
• Subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatments within 4 weeks prior to baseline visit
• Subjects who had dupilumab or any other biologics within 6 months prior to baseline visit
• Subjects who take any systemic anti-infective or antibiotic treatments within 1 week prior to baseline visit
• Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks prior to screening
• Subjects who have active malignancy or history of cancer in 5 years prior to screening, except for treated cautions basal cell carcinoma and in situ cervical cancer
• Subjects who have any other skin diseases that would affect the ability to assess the AD
• Subjects who are taking any other concomitant drug that, in the opinion of the PI, may cause interference with the treatment
• Subjects who participated in another drug or device trial within 4 weeks prior to screening...etc

Sponsors & Collaborators

• Shaperon: lead

Study Sites (12)

Cahaba Dermatology Skin Health Center

Birmingham, Alabama, 35244, United States

Location

RAOOF MD Dermatology

Encino, California, 16133, United States

Location

L.A. Universal Research Center, Inc.

Los Angeles, California, 90057, United States

Location

Zenith Research Inc.

Los Angeles, California, 90212, United States

Location

Continental Clinical Solutions, LLC

Towson, Maryland, 21204, United States

Location

Revival Research Institute, LLC

Southfield, Michigan, 19505, United States

Location

Sadick Dermatology

New York, New York, 10075, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Gachon University Gil Medical Center

Seoul, South Korea

Location

Seoul National University Bundang Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A Randomized, Double-blind, Placebo-controlled Study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: September 6, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (8); KR (4)