RECRUITING

Phase 2 Trial of HY209gel in Atopic Dermatitis Patients

Conditions

Atopic Dermatitis Atopic Dermatitis Eczema Atopic Dermatitis of Scalp

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2024-03-01

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06024499

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.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Shaperon Shaperon

CONTACT

82-2-6083-8315

seoh@shaperon.com

Shaperon Shaperon

CONTACT

Study Locations (Sites)

Cahaba Dermatology Skin Health Center

Birmingham, Alabama, 35244

United States

RAOOF MD Dermatology

Encino, California, 16133

United States

Continental Clinical Solutions, LLC

Towson, Maryland, 21204

United States

Sadick Dermatology

New York, New York, 10075

United States

Collaborators and Investigators

Sponsor: Shaperon

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2024-03-01

Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

Atopic Dermatitis
Atopic Dermatitis Eczema
Atopic Dermatitis of Scalp