What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, particularly topical applications like corticosteroids and calcineurin inhibitors, have known side effects. Topical corticosteroids can cause skin thinning, stretch marks, and increased susceptibility to skin infections with prolonged use. Topical calcineurin inhibitors, such as tacrolimus and pimecrolimus, may cause burning or stinging sensations at the application site and have a black box warning due to a potential increased risk of lymphoma and skin cancer. Other topical agents, like those containing pramoxine, menthol, or camphor, generally provide temporary relief with minimal side effects but can cause local irritation or allergic reactions in some individuals.

What prior FDA approvals exist?

The FDA has approved several topical treatments for atopic dermatitis aimed at reducing itch and inflammation. Notable examples include tacrolimus ointment and pimecrolimus cream, both of which are calcineurin inhibitors that modulate the immune response to reduce symptoms. Additionally, corticosteroid creams and ointments have long been a mainstay in managing atopic dermatitis due to their anti-inflammatory properties. These treatments are similar to ASN008 in their topical application and focus on alleviating itch and other symptoms associated with atopic dermatitis.

What other types of research exist?

Promising novel alternatives to ASN008 for atopic dermatitis include: 1) Topical E6005, a phosphodiesterase 4 inhibitor, which has shown safety and efficacy in reducing symptoms in clinical trials. 2) Topical tacrolimus ointment, which has been studied for its effectiveness in treating resistant pruritus. 3) SDZ ASM 981 cream, which has demonstrated efficacy in treating moderate atopic dermatitis in clinical studies.

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Unknown

ASN008 for Eczema

Phase 2

Waitlist Available

Research Sponsored by TrialSpark

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 56

Summary

This trial tests a new gel called ASN008 for people with itchy eczema. Participants will apply the gel twice a day for several weeks to see if it helps reduce their itch. The study aims to find the best dose and ensure the treatment is safe. ASN008 gel has demonstrated good safety and tolerability in healthy volunteers and is currently under investigation.

Who is the study for?

Adults over 18 with mild to moderate atopic dermatitis (eczema) for at least a year, who haven't had severe flare-ups in the past month. They should have a certain level of itchiness and eczema covering no more than 20% of their body. Participants must not be pregnant or planning pregnancy and agree to follow trial procedures.

What is being tested?

The trial is testing ASN008's ability to relieve itching from eczema by comparing three different doses against a placebo. Participants will apply either ASN008 or a non-medicated cream twice daily for four weeks while researchers monitor which dose is most effective and safe.

What are the potential side effects?

Potential side effects are not specified, but generally could include skin irritation, redness, or allergic reactions related to the application of topical treatments like ASN008.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Daily Peak Pruritus NRS

Secondary study objectives

Mean change from Baseline in Eczema Area and Severity Index (EASI) score

Mean change from Baseline in the Patient-Oriented Eczema Measure (POEM)

Mean change from Baseline in total body surface area (BSA)

+1 more

Other study objectives

Incidence of TEAEs leading to treatment discontinuation

Inter- and Intra-subject variability of ASN008 Pharmacokinetics characterized by Peak Plasma Concentration (Cmax)

Inter- and Intra-subject variability of ASN008 Pharmacokinetics characterized by area under the plasma concentration versus time curve (AUC)

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: ASN008 5%Experimental Treatment1 Intervention

ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)

Group II: ASN008 2.5%Experimental Treatment1 Intervention

ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)

Group III: ASN008 1.25%Experimental Treatment1 Intervention

ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)

Group IV: ASN008 Matching VehiclePlacebo Group1 Intervention

ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ASN008

2023

Completed Phase 2

~140

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Atopic Dermatitis (AD) include moisturizers, topical corticosteroids, and topical immunomodulators like tacrolimus and pimecrolimus. Moisturizers help restore the skin barrier, reducing dryness and preventing irritants from penetrating the skin. Topical corticosteroids reduce inflammation and immune responses, alleviating redness and itching. Tacrolimus and pimecrolimus inhibit calcineurin, a protein involved in activating T-cells, thereby reducing inflammation and immune activity. These treatments are crucial for AD patients as they target the primary mechanisms of skin barrier dysfunction and immune dysregulation, providing relief from itching and improving skin health.

Prevalence, pathophysiology and management of itch in epidermolysis bullosa.Management of Itch in Atopic Dermatitis.Topical Application of Angelica sinensis Improves Pruritus and Skin Inflammation in Mice with Atopic Dermatitis-Like Symptoms.