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

Trial Summary

What is the purpose of this trial?

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.

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.

What makes HY209gel unique for treating eczema?

HY209gel is unique because it uses a water-based hydrogel vehicle that significantly improves skin hydration without impairing the skin's barrier function, which is crucial for managing eczema. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. United States 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. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. Italy pubmed.ncbi.nlm.nih.gov

What's new in the treatment of eczemas. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Steroid-free emollient formulations reduce symptoms of eczema and improve quality of life. [2014]

5. Switzerland pubmed.ncbi.nlm.nih.gov

New Cosmetic Formulation for the Treatment of Mild to Moderate Infantile Atopic Dermatitis. [2020]