HY209gel for Eczema
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Shaperon
Must not be taking: Corticosteroids, Cyclosporine, Biologics, others
Disqualifiers: Unstable AD, Cancer, Skin diseases, others
Prior Safety Data
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.
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
+3 more
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.
+7 more
Trial 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
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
RAOOF MD DermatologyEncino, CA
Cahaba Dermatology Skin Health CenterBirmingham, AL
Sadick DermatologyNew York, NY
Continental Clinical Solutions, LLCTowson, MD
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Who Is Running the Clinical Trial?
ShaperonLead Sponsor
References
Transepidermal water loss (TEWL) and corneometry with hydrogel vehicle in the treatment of atopic dermatitis: a randomized, investigator-blind pilot study. [2012]Disruption of the epidermal barrier, as indicated by a reduction in skin hydration and an increase in transepidermal water loss (TEWL) is a feature of atopic dermatitis (AD). Novel formulations of dermatologic therapies may enhance patient satisfaction and adherence and may possibly preserve and enhance epidermal barrier function. A single-center, investigator-blinded, randomized, split-body exploratory study was undertaken to assess the hydrating and barrier preserving effects of a water-based hydrogel vehicle. Subjects (n=20) with mild to moderate disease at baseline applied hydrogel vehicle or a moisturizing lotion (Eucerin Lotion®, Beiersdorf, Inc.) in a split-body fashion for two weeks. Corneometry and TEWL measurements were taken at baseline and week 2. Hydrogel vehicle produced a statistically significant improvement in skin hydration from baseline, as compared to a moisturizing lotion control. Hydrogel produced no statistically significant change in TEWL, while comparator lotion increased TEWL. Data from this pilot study indicate that the water-based hydrogel vehicle improves skin hydration and does not further impair epidermal barrier function, suggesting that it is an appropriate vehicle choice for patients with mild-to-moderate atopic dermatitis.
Clocortolone pivalate: a paired comparison clinical trial of a new topical steroid in eczema/atopic dermatitis. [2019]One hundred patients with eczema/atopic dermatitis were treated in a double-blind, paired-comparison fashion with clocortolone pivalate 0.1 percent cream and the placebo cream base. Results with the active agent were statistically significantly superior in all objective and subjective rating parameters. No adverse reactions were observed and patient acceptance of both test medications was excellent. Discussions of paired-comparison methodology and placebo response are included herein.
What's new in the treatment of eczemas. [2018]We have conducted an open label, non-comparative study in order to assess the efficacy and tolerability of Dexyane Med in combination with corticosteroids in patients with chronic hand eczema (CHE) and contact eczema (CE) in a real-life setting.
Steroid-free emollient formulations reduce symptoms of eczema and improve quality of life. [2014]Two over-the-counter products have been clinically tested for efficacy and tolerability in the treatment of atopic dermatitis. Study 1 evaluated a daily maintenance Body Cream (Eucerin Eczema Relief Body Crème) applied twice daily for 14 days, followed by treatment withdrawal for 5 days (regression period) in subjects with a history of atopic dermatitis. Study 2 evaluated an acute treatment (Eucerin Eczema Relief Instant Therapy [Instant Therapy]) for active atopic dermatitis lesions administered for 14 days. Skin barrier function, hydration, tolerability, and relief of symptoms were assessed at baseline, day 7, and day 14. Study 2 also measured itch relief and treatment impact on work, social activities, and sleep. Body Cream significantly improved skin hydration and barrier function (P
New Cosmetic Formulation for the Treatment of Mild to Moderate Infantile Atopic Dermatitis. [2020]Atopic dermatitis (AD) is a chronic cutaneous inflammatory disorder, characterized by skin barrier disruption. Dermacare is a new cosmetic formulation, which enhances moisturization, reinforces and repairs the skin barrier, and prevents cutaneous microbiota imbalance. To demonstrate its safety and efficacy, a prospective, open-label, and multicenter study was carried out on patients diagnosed with mild to moderate AD. Transepidermal water loss (TEWL), clinical severity, Desquamation Index, Patient/Investigator Global Assessments, quality of life index, and tolerance were assessed. Adverse events were recorded. Daily application of the new treatment was well tolerated, and adverse events were absent. After 14 days, TEWL showed a 36.7% significant decrease (p = 0.035). At the end of the 28-day treatment, the Desquamation Index showed a reduction in 70% of patients; Eczema Area and Severity Index were reduced by 70.4% (p = 0.002); and skin irritation showed a significant reduction (p = 0.024). Likewise, Patient and Investigator Global Assessments reported a significant improvement in conditions and an overall global worsening when patients restarted their normal treatment. Parent's Index of Quality of Life Index significantly increased by 36.4% (p < 0.05) with Dermacare. In conclusion, a regular use of this new formulation can reduce the risk of relapse and extend the steroid-free treatment periods.