HY209gel for Eczema

Recruiting at 3 trial locations

Overseen By Shaperon Shaperon

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Shaperon

Must not be taking: Corticosteroids, Cyclosporine, Biologics, others

Disqualifiers: Unstable AD, Cancer, Skin diseases, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new gel treatment, HY209GEL, for individuals with mild to moderate eczema, also known as Atopic Dermatitis. The study evaluates the gel's effectiveness and safety compared to a placebo, with participants randomly assigned to a high-dose, low-dose, or placebo group. Individuals with stable eczema for at least one month, affecting 5-30% of their body, who can read and understand study materials, may be eligible to join. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications before participating. You must not have used topical corticosteroids within 2 weeks, systemic corticosteroids or immunosuppressive treatments within 4 weeks, or certain biologics within 6 months before the trial starts. Check with the trial team to see if your current medications are affected.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that HY209gel has been tested in earlier studies for its safety in treating skin conditions like atopic dermatitis, a type of eczema. In these studies, participants generally tolerated HY209gel well. For instance, one study found that the gel caused only minor side effects and was safe for skin application. The gel's minimal absorption into the body reduces the risk of side effects affecting other areas.

Another study on a similar skin treatment, which functions similarly, also demonstrated safety and an absence of serious side effects. This suggests that treatments like HY209gel, when applied to the skin, are likely safe.

Overall, available research suggests that HY209gel is safe for individuals with mild to moderate eczema, but ongoing trials will provide further information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Unlike the standard eczema treatments, which often include topical steroids or calcineurin inhibitors, HY209gel is a distinct topical formulation designed specifically for this condition. Researchers are particularly excited about HY209gel because it offers the potential for anti-inflammatory effects without the side effects typically associated with steroids, such as skin thinning. Additionally, the gel formulation provides an easy-to-apply option that could lead to better patient adherence and more consistent outcomes. This fresh approach could offer a new hope for those who struggle with managing eczema using current therapies.

What evidence suggests that HY209gel might be an effective treatment for eczema?

Research has shown that HY209gel is being tested in this trial to assess its effectiveness in treating atopic dermatitis, also known as eczema. An earlier study on a similar treatment, NuGel, which reduces inflammation by targeting a specific protein, showed promising results. Participants using NuGel experienced fewer eczema symptoms, suggesting that this type of treatment can improve skin condition. Although HY209gel is still under investigation in this trial, these early findings offer hope for its potential effectiveness in those with mild to moderate eczema. Participants will receive either a high-dose or low-dose of HY209gel, or a placebo, to evaluate its effectiveness. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

5% to 30% of my skin is affected by atopic dermatitis.

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 with vIGA score 2 or 3 corresponding to mild to moderate AD at screening and baseline visit

Exclusion Criteria

I haven't taken steroids or immunosuppressants in the last 4 weeks.

I haven't had cancer in the last 5 years, except for treated skin cancer or cervical cancer that hasn't spread.

My skin condition has been unstable for less than 6 months or I need strong creams regularly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Dose-escalation part to evaluate pharmacokinetics, safety, and tolerability of HY209gel with 2-week treatment per cohort

2 weeks per cohort

Interim Analysis

Interim analysis for 4-week safety and efficacy data collected from Part 1 to select doses for Part 2

4 weeks

Treatment Part 2

Evaluation of efficacy and safety of HY209gel compared to placebo over an 8-week treatment period

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HY209GEL
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: PART 2 High-Dose Active Control 1 Intervention

Active group selected for PART1 as a high-dose

Group II: PART 2 Low-Dose Active Control 1 Intervention

Active group selected for PART1 as a Low-dose

Group III: PART 2 Placebo Placebo Group 1 Intervention

Placebo group

Who Is Running the Clinical Trial?

Shaperon

Lead Sponsor

Trials

6

Recruited

1,600+

Published Research Related to This Trial

In a study involving 20 patients with chronic hand eczema and contact eczema, the combination of Dexyane Med and topical corticosteroids significantly improved symptoms, with mTLSS and IGA scores showing remarkable reductions.

The treatment was well tolerated, with all patients reporting satisfaction with their results, indicating that Dexyane Med could be an effective option for managing eczema symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What's new in the treatment of eczemas. Gola, M., Carpentieri, A., Loconsole, F.[2018]

The Eucerin Eczema Relief Body Cream significantly improved skin hydration and barrier function in subjects with atopic dermatitis over 14 days, with effects lasting through a 5-day withdrawal period, and 93.8% of participants experienced reduced itching.

The Eucerin Eczema Relief Instant Therapy provided rapid relief for active atopic dermatitis lesions, improving skin hydration and symptoms like redness and itching within minutes, while also enhancing the quality of life for users. Both products were found to be safe and well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Steroid-free emollient formulations reduce symptoms of eczema and improve quality of life. Weber, TM., Babcock, MJ., Herndon, JH., et al.[2014]

Dermacare, a new cosmetic formulation for atopic dermatitis, was found to be safe and well-tolerated in a multicenter study with no reported adverse events, demonstrating its potential for daily use.

After 28 days of treatment, Dermacare significantly reduced skin barrier disruption, as shown by a 70.4% decrease in the Eczema Area and Severity Index and a 36.7% decrease in transepidermal water loss, indicating improved skin condition and quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Cosmetic Formulation for the Treatment of Mild to Moderate Infantile Atopic Dermatitis. de Lucas, R., García-Millán, C., Pérez-Davó, A., et al.[2020]

In a study involving 100 patients with eczema/atopic dermatitis, clocortolone pivalate 0.1% cream was found to be significantly more effective than a placebo in all measured outcomes, both objective and subjective.

The treatment was well-tolerated with no adverse reactions reported, indicating a high level of safety and excellent patient acceptance for both the active and placebo creams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clocortolone pivalate: a paired comparison clinical trial of a new topical steroid in eczema/atopic dermatitis. Rosenthal, AL.[2019]

In a study involving 20 subjects with mild to moderate atopic dermatitis, a water-based hydrogel vehicle significantly improved skin hydration compared to a moisturizing lotion (Eucerin Lotion®).

The hydrogel did not worsen transepidermal water loss (TEWL), while the comparator lotion actually increased TEWL, indicating that the hydrogel is a suitable option for preserving epidermal barrier function in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transepidermal water loss (TEWL) and corneometry with hydrogel vehicle in the treatment of atopic dermatitis: a randomized, investigator-blind pilot study. Kircik, LH.[2012]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40458407

a proof-of-concept study with Post-hoc biomarker analysis A phase 2a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy and safety of NuGel, a novel topical GPCR19-mediated inflammasome ...

2. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1560447/full

Phase 2a trial: NuGel for atopic dermatitis This study assessed NuGel, a topical GPCR19 agonist, for efficacy, safety, and predictive baseline biomarkers in AD patients.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06024499

Phase 2 Trial of HY209gel in Atopic Dermatitis Patients 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12127193/

NuGel for Atopic Dermatitis: Phase 2a Trial Results This study assessed NuGel, a topical GPCR19 agonist, for efficacy, safety, and predictive baseline biomarkers in AD patients.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04530643

Study Details | HY209 Gel for Atopic Dermatitis | Phase II Most clinical studies have one primary outcome measure, but some have more than one. ... The main reason for the clinical trial. The types of primary purpose are: ...

6. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.70242

Safety, Tolerability, and Pharmacokinetics of Single and ... Sodium taurodeoxycholate gel was safe and well-tolerated, with minimal systemic absorption, suggesting its safety as a topical AD treatment.

7. delta.larvol.com delta.larvol.com/Products/?ProductId=e19a94d5-5b64-4179-8bb3-3d48bab252aa

NuGel (taurodeoxycholic acid) / Shaperon - Dermatitis A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2b Part 1 Study of a Topical GPCR19 Agonist in Patients with Mild-to-Moderate Atopic ...