Positive topline results were announced from a phase 3 trial evaluating the efficacy and safety of roflumilast foam for the treatment of patients with moderate to severe seborrheic dermatitis.

Roflumilast foam is an investigational topical formulation of a highly potent and selective phosphodiesterase type 4 inhibitor. The parallel group, double blind, vehicle-controlled STRATUM study (ClinicalTrials.gov Identifier: NCT04973228) included 457 patients 9 years of age and older with moderate to severe seborrheic dermatitis. Patients were randomly assigned 2:1 to receive roflumilast foam 0.3% applied once daily or vehicle for 8 weeks.

The primary endpoint was the proportion of patients achieving Investigator Global Assessment (IGA) success at week 8, defined as an IGA score of ‘clear’ or ‘almost clear’ with at least a 2-point improvement.

Findings showed that 80.1% of patients treated with roflumilast foam achieved IGA success at week 8 compared with 59.2% of patients treated with vehicle (P <.0001). More than 50% of patients treated with roflumilast foam achieved an IGA score of ‘clear’ at week 8.

Statistically significant improvements were also observed with roflumilast vs vehicle on key secondary endpoints including itch, scaling, and erythema. Roflumilast foam was found to be well tolerated with most adverse events being mild to moderate in severity.

“Despite the prevalence and impact on quality of life of seborrheic dermatitis, there remains significant unmet need for new options to treat this condition, with individuals today left to manage their symptoms with multiple treatments and complex application routines,” said Dr Zoe Draelos, study investigator, dermatologist in High Point, North Carolina, and President, Dermatology Consulting Services, PLLC. “As both a trial investigator and a clinician, I am excited by these results because they demonstrate the potential for roflumilast foam to be a well-tolerated, easy-to-use, steroid-free treatment option for adults and adolescents with moderate to severe seborrheic dermatitis.”

The Company plans to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the first half of 2023.

Reference

Arcutis announces positive topline results from STRATUM pivotal phase 3 trial of roflumilast foam 0.3% in seborrheic dermatitis. News release. Arcutis Biotherapeutics Inc. Accessed June 6, 2022. https://www.globenewswire.com/news-release/2022/06/06/2456603/0/en/Arcutis-Announces-Positive-Topline-Results-from-STRATUM-Pivotal-Phase-3-Trial-of-Roflumilast-Foam-0-3-in-Seborrheic-Dermatitis.html