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Atopic DermatitisPhase 2NCT04530643

A Phase II Study of HY209 Gel for Atopic Dermatitis Patients (Shaperon)

A Phase 2 study testing HY209 0.3% and HY209 0.5% in people with Atopic Dermatitis, run by Shaperon at 3 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Randomized, Double-blinded, Placebo-controlled, Parallel, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of HY209 gel for Patients with Atopic Dermatitis Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
HY209 0.3% and HY209 0.5%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
3 sitesSouth Korea
Study dates
26 Aug 2020to 7 Sep 2021
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 19 Years and older, Male or female
  • Those who have a clinical diagnosis of atopic dermatitis according to the criteria of Hanifin and Rajka
  • IGA of 2 or 3 at Baseline Visit
  • BSA covered with AD of at least 5% and no more than 40% at Baseline Visit
  • Those who must be capable of giving informed consent and willing to comply with all clinic visits and study-related procedures until study completion

Who cannot join

  • Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Taurodeoxycholate , aspirin, antibiotics, etc.)
  • Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic diseases, mental diseases, especially hemorrhagic diseases (hemophilia, von Willebrand disease, etc.), cardiovascular diseases (coronary artery diseases, congestive heart failure, arrhythmia, cerebrovascular diseases, etc.) or who have a history of those diseases
  • Those who have systemic infection at Screening Visit
  • Those who have asthma at Screening Visit
  • Treatment with steroids, oral antibiotics, body photochemotherapy, immunosuppressive drug within 4 weeks before the Baseline Visit (Day 1)
  • Treatment with topical steroids, antibiotics within 2 weeks before the Baseline Visit (Day 1)
Show all 19Show fewer
  • Those who have taken a prohibited concomitant medication
  • Those who have Creatinine values more than two times of the upper limit of normal range at screening test
  • Those who have AST/ALT values more than two times of the upper limit of normal range at screening test
  • Those who have been taking medicines by participating in other clinical trials or bioequivalence studies within 6 months prior to the date of first administering (the time from the date of participation in the previous clinical trial is based on the date of administration of each applicable study drug. However, if the half-life of the study drug taken in a previously participated clinical trial is 2 weeks or more, 5 times the expected half-life of the study drug)
  • Those who have history of HIV infection or HIV seropositivity at Screening Visit
  • Those who are positive or undeterminable in serological tests (HBsAg, HBcAb, or Hepatitis C virus antibody, Hepatitis B virus antibody) at Screening Visit
  • Those who have skin diseases or conditions affecting skin that may interfere with clinical trial evaluation (acne, impetigo, chicken pox, active herpes simplex at Baseline, corticosteroid induced perioral dermatitis, tinea corporis/intertriginous, head lice or scabies)
  • Those who have had malignant tumor within 5 years prior to Baseline Visit
  • Atopic Dermatitis treatment with topical drug (containing ceramide, hyaluronic acid, urea or filaggrin) during Screening period
  • Those who have a history of drinking or substance abuse within 2 years
  • Those who are positive urine drug screening tests at Screening Visit i.e., amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate, cotinine)
  • Those who are pregnant, breastfeeding, or considering pregnancy during the study
  • Those who are deemed unsuitable for participating in clinical trials under the judgement of investigator

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13496

  • Seoul National University Hospital

    Seoul, Jongno-gu, 03080

  • Hallym University Kangnam Scared Heart Hospital

    Seoul, Yeongdeungpo-gu, 07441

Other trials in South Korea

About this study

Official title: A Randomized, Double-blinded, Placebo-controlled, Parallel, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of HY209 Gel for Patients With Atopic Dermatitis

A Randomized, Double-blinded, Placebo-controlled, Parallel, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of HY209 gel for Patients with Atopic Dermatitis

Read the detailed description

A composition containing G Protein Coupled Receptor 19(GPCR19) agonist HY209 and a derivative thereof is found to have a considerable effect in the treatment of atopic dermatitis and is proposed as a pharmaceutical ingredient for prevention, treatment and improvement of atopic dermatitis. The GPCR19 agonist, HY209, is superior to conventional steroid ointment and immunosuppressant ointment in the treatment and improvement of allergic dermatitis. It directly reduces the amount of serum immunoglobulin E, which is a major factor of allergic dermatitis, It increases the T helper type 1(TH1) cytokines that alleviate allergic dermatitis pathologies, reduces the T helper type 2(TH2) cytokines that aggravate allergic dermatitis pathologies, and reduces the infiltration of mast cells, eosinophils and neutrophils into the dermal cells. Thus it can be utilized as a therapeutic drug composition for atopic dermatitis.

Being tested
HY209 0.3%, HY209 0.5%, 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.

  • HY209 0.3%Drug

    Also called HY209 gel

    25 subjects will be assigned to drug (HY209 0.3% gel).

  • HY209 0.5%Drug

    Also called HY209 gel

    25 subjects will be assigned to drug (HY209 0.5% gel).

  • PlaceboDrug

    25 subjects will be assigned to drug (Placebo).

Study groups in NCT04530643
Study groupRoleWhat they receive
HY209 0.3%Experimentalmultiple dose of HY209 0.3% gel
Receives: Drug: HY209 0.3%
HY209 0.5%Experimentalmultiple dose of HY209 0.5% gel
Receives: Drug: HY209 0.5%
PlaceboPlacebo comparatormultiple dose of Placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement rate in EASI score

    As measured by Eczema Area and Severity Index (EASI)

    Measured: Up to Week 4

Secondary outcomes (4)

  1. Improvement rate in IGA score

    As measured by Investigator Global Assessment (IGA)

    Measured: Up to Week 4

  2. Improvement rate Pruritus NRS

    As measured by Pruritus Numeric Rating Scale (NRS)

    Measured: Up to Week 4

  3. Change in total IgE

    As measured by total Immunoglobin E (IgE)

    Measured: Up to Week 4

  4. Change in Eosinophil count

    As measured by Eosinophil count

    Measured: Up to Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2020
  2. Study start26 Aug 2020
  3. Primary completion7 Sep 2021
  4. Study completion7 Sep 2021

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04530643
Sponsor's protocol ID
HY209-Gel
Status last verified
Jan 2022
First submitted
25 Aug 2020
Last updated
28 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Baek GH, Kim BR, Shin JW, Huh CH, Hwang J, Ko S, Kim S, Ho PS, Kim KH, Park CW, Seo SJ, Park CO, Shin D, Kim Y, Kim Y, Seong SY, Na JI. A phase 2a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy and safety of NuGel, a novel topical GPCR19-mediated inflammasome inhibitor, in patients with mild to moderate atopic dermatitis: a proof-of-concept study with Post-hoc biomarker analysis. Front Immunol. 2025 May 19;16:1560447. doi: 10.3389/fimmu.2025.1560447. eCollection 2025.

    PubMed 40458407

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HY209 0.3% and HY209 0.5% in people with Atopic Dermatitis, run by Shaperon at 3 sites in South Korea.

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 5 inclusion and 19 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 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in 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?

Improvement rate in EASI score (time frame: Up to Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04530643, which also lists 1 linked publication.

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 28 Jan 2022.

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