On July 29, 2022, the U.S. Food and Drug Administration (FDA) approved Arcutis Biotherapeutics’ ZORYVE™ (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis in individuals 12 years and older, including in sensitive intertriginous areas. This once-daily, steroid-free cream is the first and only topical phosphodiesterase-4 (PDE4) inhibitor to receive FDA approval for this indication and is designed to simplify disease management for patients through a combination of efficacy, safety, and ease of use. DelRicht Research contributed to the clinical trial program supporting this approval, with sites in New Orleans and Baton Rouge playing a key role in patient recruitment and trial execution.

Innovative, Targeted Relief for a Chronic Skin Condition

Plaque psoriasis affects an estimated nine million Americans and is known for causing persistent itching, scaling, and discomfort. ZORYVE’s approval follows the successful completion of the pivotal Phase 3 DERMIS-1 and DERMIS-2 studies, which demonstrated significant improvements in disease clearance, itch reduction, and treatment outcomes across a variety of body areas, including those traditionally difficult to treat. By Week 8, up to 42% of participants reached clear or almost clear skin, with results sustained through 52 weeks in long-term extension data.

ZORYVE also showed a favorable safety profile, with minimal application site reactions and no systemic steroid-related side effects. Its proprietary HydroARQ™ Technology creates a non-greasy, fast-absorbing cream that supports daily use without restrictions on duration.

DelRicht Research Contributes to FDA Success

DelRicht Research is proud to have supported the clinical trial program that led to ZORYVE’s approval. Three experienced principal investigators from our network played a key role in the study’s successful execution:

Dr. Deirdre Hooper and Dr. Sarah Jackson of Audubon Dermatology in New Orleans, LA, have led various clinical trials with DelRicht since 2016.
Dr. Ira Thorla of LA Dermatology Associates in Baton Rouge, LA, has contributed to multiple trials with DelRicht since 2018.

Their expertise and dedication ensured strong patient recruitment, protocol adherence, and high-quality data, ultimately accelerating the path to approval for this important treatment.

A Step Forward in Patient-Centered Dermatology

“This approval represents a major advancement for patients living with chronic skin conditions,” said Marshall Morris, Partner at DelRicht Research. “ZORYVE’s formulation fills a critical gap in dermatology, providing a steroid-free, well-tolerated option that can be used on even the most sensitive areas. We are proud of the role our investigators played in bringing this therapy to market.”

“This approval represents a major advancement for patients living with chronic skin conditions. ZORYVE’s formulation fills a critical gap in dermatology, providing a steroid-free, well-tolerated option that can be used on even the most sensitive areas. We are proud of the role our investigators played in bringing this therapy to market.”

— Marshall Morris, Partner at DelRicht Research

With commercial availability beginning mid-August 2022, ZORYVE offers a streamlined option for patients and providers alike, reinforcing the growing emphasis on convenience, safety, and quality of life in dermatologic care.

To learn more about the FDA approval and product details, visit arcutis.com. DelRicht Research remains committed to advancing innovative therapies through site-level excellence and trusted research partnerships.

Read the full press release from Arcutis Biotherapeutics.