Atopic DermatitisPhase 2NCT06024499
Phase 2 Trial of HY209gel in Atopic Dermatitis Patients
A Phase 2 study testing HY209GEL Active in people with Atopic Dermatitis and Atopic Dermatitis Eczema, run by Shaperon at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atopic Dermatitis, Atopic Dermatitis Eczema, Atopic Dermatitis of Scalp
- What is being tested?
- HY209GEL Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 1 Mar 2024to 13 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States8 sites
Cahaba Dermatology Skin Health Center
Birmingham, Alabama, 35244
RAOOF MD Dermatology
Encino, California, 16133
L.A. Universal Research Center, Inc.
Los Angeles, California, 90057
Zenith Research Inc.
Los Angeles, California, 90212
Sadick Dermatology
New York, New York, 10075
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Revival Research Institute, LLC
Southfield, Michigan, 19505
Continental Clinical Solutions, LLC
Towson, Maryland, 21204
South Korea4 sites
Gachon University Gil Medical Center
Seoul
Seoul National University Bundang Hospital
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
About this study
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)
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.
Read the detailed description
Part 1 (2 cohorts): Total 33 subjects
- Cohort A: 15 subjects (6 HY209gel 0.5%, 6 HY209gel 1%, and 3 placebo)
- Cohort B: 9 subjects (6 HY209gel 2%, and 3 placebo)
- Cohort C: 9 subjects (6 HY209gel 4%, and 3 placebo)
Part 2 (3 treatment groups): Total 177 subjects
- Low dose of HY209gel: 59 subjects
- High dose of HY209gel: 59 subjects
- Placebo (Vehicle): 59 subjects
Part 1 is a dose-escalation part of HY209gel using lower doses of HY209gel (0.5% and 1%) with escalation (HY209gel 2% and 4%) to evaluate the pharmacokinetics(PK), safety, and tolerability of HY209gel treatment. Escalation to the next dose level will be decided by the Safety Monitoring Committee(SMC) that will review all available safety data of the planned dose level within the timeline specified on SMC charter after all enrolled subjects of each cohort complete 2-week treatment and determine the escalation to the next dose to be safe.
Based on the interim analysis for 4-week safety and efficacy data collected from Part 1, two doses will be selected for use in Part 2, which will enroll up to 177 subjects in 3 treatment arms (59 subjects per treatment arm) to evaluate the efficacy and safety of HY209gel, compared to placebo (vehicle) for 8-week treatment period.
- Being tested
- HY209GEL Active, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HY209GEL ActiveDrug
Selected two among four doses (HY209GEL 0.5% or 1% or 2% or 4%) in PART1
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PART 2 High-Dose | Active comparator | Active group selected for PART1 as a high-dose Receives: Drug: HY209GEL Active |
| PART 2 Low-Dose | Active comparator | Active group selected for PART1 as a Low-dose Receives: Drug: HY209GEL Active |
| PART 2 Placebo | Placebo comparator | Placebo group Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in Eczema Area and Severity Index (EASI) score
To achieve lower score means disease improvement .
Measured: at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Mar 2024
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaperon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024499
- Sponsor's protocol ID
- HY209-AD-02
- Status last verified
- Jun 2026
- First submitted
- 24 Jul 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06024499
- Acronym / sponsor ID
- HY209-AD-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- ShaperonIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Part 1 (2 cohorts): Total 33 subjects
- Cohort A: 15 subjects (6 HY209gel 0.5%, 6 HY209gel 1%, and 3 placebo)
- Cohort B: 9 subjects (6 HY209gel 2%, and 3 placebo)
- Cohort C: 9 subjects (6 HY209gel 4%, and 3 placebo)
Part 2 (3 treatment groups): Total 177 subjects
- Low dose of HY209gel: 59 subjects
- High dose of HY209gel: 59 subjects
- Placebo (Vehicle): 59 subjects
Part 1 is a dose-escalation part of HY209gel using lower doses of HY209gel (0.5% and 1%) with escalation (HY209gel 2% and 4%) to evaluate the pharmacokinetics(PK), safety, and tolerability of HY209gel treatment. Escalation to the next dose level will be decided by the Safety Monitoring Committee(SMC) that will review all available safety data of the planned dose level within the timeline specified on SMC charter after all enrolled subjects of each cohort complete 2-week treatment and determine the escalation to the next dose to be safe.
Based on the interim analysis for 4-week safety and efficacy data collected from Part 1, two doses will be selected for use in Part 2, which will enroll up to 177 subjects in 3 treatment arms (59 subjects per treatment arm) to evaluate the efficacy and safety of HY209gel, compared to placebo (vehicle) for 8-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PART 2 High-Dose | Active comparator | Drug: HY209GEL ActiveActive group selected for PART1 as a high-dose |
| PART 2 Low-Dose | Active comparator | Drug: HY209GEL ActiveActive group selected for PART1 as a Low-dose |
| PART 2 Placebo | Placebo comparator | Other: PlaceboPlacebo group |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HY209GEL ActiveSelected two among four doses (HY209GEL 0.5% or 1% or 2% or 4%) in PART1 | Drug | PART 2 High-Dose, PART 2 Low-Dose |
| PlaceboPlacebo | Other | PART 2 Placebo |
Primary outcome
Percentage change in Eczema Area and Severity Index (EASI) score
Time frame: at Week 8
To achieve lower score means disease improvement .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HY209GEL Active in people with Atopic Dermatitis and Atopic Dermatitis Eczema, run by Shaperon at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in Eczema Area and Severity Index (EASI) score (time frame: at Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.