Phase 2 Trial of HY209gel in Atopic Dermatitis Patients

Description

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

Study Overview

Study Details

Study overview

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.

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of HY209 Gel in Patients With Mild to Moderate Atopic Dermatitis(AD)

Phase 2 Trial of HY209gel in Atopic Dermatitis Patients

Condition
Atopic Dermatitis
Intervention / Treatment

-

Contacts and Locations

Birmingham

Cahaba Dermatology Skin Health Center, Birmingham, Alabama, United States, 35244

Encino

RAOOF MD Dermatology, Encino, California, United States, 16133

Towson

Continental Clinical Solutions, LLC, Towson, Maryland, United States, 21204

New York

Sadick Dermatology, New York, New York, United States, 10075

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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 strong CYP3A4 inhibitor or 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

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Shaperon,

Study Record Dates

2026-03-31