What side effects are associated with this type of intervention?

Common treatments for Atopic Dermatitis, particularly those with anti-inflammatory or immunomodulatory action, have various side effects. Topical corticosteroids can cause skin thinning, stretch marks, and systemic absorption issues with prolonged use. Topical calcineurin inhibitors like tacrolimus and pimecrolimus may cause burning or itching at the application site and have a potential risk of lymphoma with long-term use. Dupilumab, a systemic treatment, can lead to injection site reactions, conjunctivitis, and rare cases of facial redness. JAK inhibitors, such as baricitinib, may cause nasopharyngitis, headache, and increased risk of infections. It is essential to discuss these potential side effects with a healthcare provider to tailor the treatment plan appropriately.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis that have anti-inflammatory or immunomodulatory actions. Dupilumab, a monoclonal antibody that inhibits IL-4 and IL-13 signaling, is one of the most notable recent approvals for moderate-to-severe atopic dermatitis. Other treatments include topical calcineurin inhibitors like tacrolimus and pimecrolimus, which modulate the immune response to reduce inflammation. Additionally, systemic therapies such as cyclosporine, methotrexate, and azathioprine have been used, although they are not specifically FDA-approved for atopic dermatitis but are used off-label due to their immunosuppressive properties.

What other types of research exist?

Promising novel alternatives for atopic dermatitis treatment in 2024 include abrocitinib and upadacitinib. Both are Janus kinase (JAK) inhibitors that have shown efficacy and safety in phase 3 trials. Additionally, tralokinumab, an IL-13 inhibitor, has demonstrated positive results in phase 3 trials for moderate-to-severe atopic dermatitis.

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SCD-044 for Eczema (SOLARES-AD-1 Trial)

Phase 2

Waitlist Available

Research Sponsored by Sun Pharmaceutical Industries Limited

Eligibility Criteria Checklist

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

Must have

Males and non-pregnant non-lactating females, diagnosed with chronic atopic dermatitis for ≥ 1 year at Screening and Baseline based on Eichenfield revised criteria of Hanifin and Rajka

Aged at least 18 years

Must not have

Female Subjects who are pregnant, nursing, or planning to become pregnant during study participation or within 6 months of completing the study

Known organ complications of Diabetes mellitus such as reduced renal function, significant retinal pathology or neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 36

Summary

This trial is testing a new medication called SCD-044 to see if it can help people with moderate to severe atopic dermatitis by reducing symptoms like itching and inflammation.

Who is the study for?

This trial is for adults over 18 with moderate to severe atopic dermatitis (eczema) that's been diagnosed for at least a year. It's not open to pregnant or nursing women, those planning pregnancy soon, or individuals with complications from diabetes like kidney issues, eye problems, or neuropathy.

What is being tested?

The study tests the effectiveness and safety of SCD-044 in three different doses compared to a placebo. Participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting in this Phase II trial.

What are the potential side effects?

While specific side effects of SCD-044 aren't listed here, common reactions may include skin irritation at the application site, potential allergic reactions, and other symptoms typical of treatments affecting the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had chronic atopic dermatitis for over a year.

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I am 18 years old or older.

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I have moderate to severe eczema.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, nursing, or planning to become pregnant soon.

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I have diabetes-related complications like kidney issues, eye problems, or nerve damage.

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I have had or currently have uveitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 36 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Adverse events.

Dermatology Life Quality Index (DLQI)

Eczema Area and Severity Index (EASI) score

+8 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: SCD-044 Tablets_Dose 1Active Control1 Intervention

SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.

Group II: SCD-044 Tablets_Dose 2Active Control1 Intervention

SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.

Group III: SCD-044 Tablets_Dose 3Active Control1 Intervention

SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.

Group IV: Placebo of SCD-044 productPlacebo Group1 Intervention

Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.

0 / 6Eligibility criteria met

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 topical corticosteroids, calcineurin inhibitors, and biologics like dupilumab. Topical corticosteroids reduce inflammation by inhibiting multiple inflammatory cytokines, providing rapid relief from itching and redness. Calcineurin inhibitors, such as tacrolimus and pimecrolimus, suppress T-cell activation, thereby reducing immune responses that contribute to AD. Dupilumab, a biologic, targets the interleukin-4 receptor alpha, inhibiting the signaling pathways of IL-4 and IL-13, which are key drivers of the inflammatory process in AD. These treatments are crucial for managing AD as they address the root causes of inflammation and immune dysregulation, leading to improved skin condition and quality of life for patients.