New EADV Insights on ZORYVE (roflumilast) Clinical Findings

New Clinical Insights on ZORYVE at EADV Congress

Westlake Village, Calif. and Paris – Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), a prominent leader in the immuno-dermatology field, has announced significant new data surrounding the efficacy of ZORYVE (roflumilast). This innovative treatment is gaining attention for its effectiveness across various common skin conditions, including seborrheic dermatitis, atopic dermatitis, and plaque psoriasis. The findings will be showcased at the Annual European Academy of Dermatology and Venereology (EADV) Congress.

ZORYVE Foam 0.3% for Diverse Skin Types

On September 19, 2025, an oral presentation will feature the results from a subgroup analysis of the Phase 3 STRATUM Trial, led by Raj Chovatiya, MD, PhD, MSCI. This research reinforces the capability of ZORYVE foam 0.3% to effectively address seborrheic dermatitis across a diverse pool of patients, demonstrating improvements that highlight the treatment's adaptability based on individual patient profiles, such as ethnicity and skin type.

Key Findings from the STRATUM Trial

The analysis revealed significant improvements in symptoms of seborrheic dermatitis. The Investigator Global Assessment (IGA) Success rate at Week 8 was notably higher in patients using ZORYVE foam compared to those using a placebo (79.5% vs 58.0%). This success was consistent across various demographic groups, showcasing ZORYVE's broad applicability and reliability.

Enhancements in Patient Comfort

In addition to alleviating skin signs, there was also a notable reduction in itch severity measured by the Worst Itch-Numeric Rating Scale (WI-NRS), with patients reporting substantial relief and improved comfort. Results indicated high satisfaction with the treatment across various ethnic subgroups, an essential factor in confirming its safety and efficacy.

Advancements in Treating Atopic Dermatitis in Young Children

A separate presentation at the EADV Congress will focus on the caregiver-reported outcomes from the Phase 3 INTEGUMENT-PED Trial. This trial assessed children between the ages of 2 and 5 who were treated with investigational ZORYVE cream 0.05%. The data indicated significant improvements in the symptoms and overall quality of life for these young patients.

Patient-Reported Outcomes

The caregivers noted that after four weeks of treatment, children experienced considerable enhancements in both the frequency and severity of atopic dermatitis symptoms. These outcomes included marked reductions in itch, sleep disruption, and overall dryness, which are critical markers of this condition’s impact on young lives.

Consistent Tolerability Signals

Notably, ZORYVE cream 0.05% displayed a favorable safety profile, with little to no irritation reported, encouraging further exploration of its use in pediatric dermatology.

Treatment for Plaque Psoriasis: Effective Solutions for Sensitive Areas

The Phase 3 DERMIS-1/2 and ARRECTOR Trials examined the effect of ZORYVE cream 0.3% and foam 0.3% on plaque psoriasis, particularly in sensitive areas such as the face and genitals. Results indicated that, like in the other studies, both formulations were well tolerated, leading to significant improvements in symptom relief at Week 8.

Understanding Psoriasis Treatment Across Age Groups

Furthermore, a presentation on strategies for managing genital psoriasis emphasized the need for comprehensive care across all age brackets—from pediatric patients to the elderly. These recommendations aim to facilitate better diagnosis and tailored treatment options, ensuring effective management of this challenging condition.

The Commitment of Arcutis to Innovative Dermatology

Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer of Arcutis, emphasized the company's ongoing commitment to innovative solutions in dermatology. The findings presented at the EADV underscore ZORYVE's versatility and impact on managing chronic immune-mediated skin conditions.

Overall, the data presented highlights how ZORYVE stands at the forefront of treatment options for individuals suffering from these debilitating skin conditions, contributing meaningful advancements to patient care.

Frequently Asked Questions

What is ZORYVE used for?

ZORYVE is a topical treatment for atopic dermatitis, seborrheic dermatitis, and plaque psoriasis, known for its effectiveness across various skin conditions.

Who is the developer of ZORYVE?

Arcutis Biotherapeutics, Inc. is the developer and innovator behind ZORYVE, focusing on skin conditions and therapies that improve patient quality of life.

What are the benefits of ZORYVE foam?

ZORYVE foam has shown effectiveness in reducing symptoms of seborrheic dermatitis and psoriasis in diverse populations, showcasing its adaptability across different skin types.

Is ZORYVE safe for children?

Yes, studies indicate that ZORYVE cream 0.05% has been well tolerated in children aged 2–5 years with atopic dermatitis.

How does ZORYVE improve quality of life?

Patients report significant symptom relief with ZORYVE, leading to improved daily living and reduced impact on family dynamics.

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