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HY209gel for Eczema

Phase 2
Recruiting
Research Sponsored by Shaperon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with 5% to 30% of total body surface area (BSA) affected by AD at screening and baseline visits
Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist
Must not have
Subjects with 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 with any other skin diseases that would affect the ability to assess the AD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 8

Summary

This trial is a study in patients with mild to moderate Atopic Dermatitis (AD) that will be conducted at multiple centers. It is a phase 2 study with two parts, and it will

Who is the study for?
Adults with mild to moderate Atopic Dermatitis (AD) can join this trial. They must have been diagnosed by a dermatologist at least 6 months ago, have AD affecting 5-30% of their body, and be able to consent. People are excluded if they don't meet these criteria.
What is being tested?
The study is testing HY209GEL against a placebo in people with AD. It's randomized (participants are assigned randomly), double-blind (neither participants nor researchers know who gets what treatment), and placebo-controlled.
What are the potential side effects?
Possible side effects aren't specified here but generally could include skin irritation, redness, or itching where the gel is applied. Since it's a test for safety and effectiveness, monitoring for any adverse reactions will be part of the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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5% to 30% of my skin is affected by atopic dermatitis.
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I have been diagnosed with atopic dermatitis by a dermatologist.
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I had Alzheimer's diagnosed over 6 months ago and have been stable for the last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had cancer in the last 5 years, except for treated skin cancer or cervical cancer that hasn't spread.
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I do not have skin conditions that could interfere with my eczema assessment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage change in Eczema Area and Severity Index (EASI) score

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: PART 2 High-DoseActive Control1 Intervention
Active group selected for PART1 as a high-dose
Group II: PART 2 Low-DoseActive Control1 Intervention
Active group selected for PART1 as a Low-dose
Group III: PART 2 PlaceboPlacebo Group1 Intervention
Placebo group

Find a Location

Who is running the clinical trial?

ShaperonLead Sponsor
5 Previous Clinical Trials
1,374 Total Patients Enrolled
~122 spots leftby Oct 2025
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