Phase 3 Data Indicates Roflumilast Foam 0.3% Well-Tolerated in Seborrheic Dermatitis

Today, Arcutis Biotherapeutics announced phase 3 data from the STRATUM trial, which found that 80.1% of patients with seborrheic dermatitis who were treated with roflumilast foam 0.3% achieved Investigator Global Assessment (IGA) Success compared to 59.2% of patients treated with vehicle cream (P<0.0001).

The once-daily topical foam formulation is considered highly potent and is currently being developed to treat inflammatory dermatoses, with a keen focus on hair-bearing areas of the body.

The STRATUM trial featured a total 0f 457 participants 9 years and older with severe seborrheic dermatitis. Participants were randomized 2:1 roflumilast foam to vehicle.

A statement released by the pharmaceutical company noted that improvement with roflumilast was recorded early into the trial, with the therapy separating statistically from the vehicle cream regarding IGA Success at week 2.

By week 8, more than 50% of patients treated with roflumilast foam achieved an IGA score of “clear”, and key secondary endpoints such as reductions in itch, scaling, and redness were more frequently achieved with the topical foam compared to the vehicle cream.

“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 study investigator Zoe Draelos, MD, 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.”

Notably, no treatment-related serious adverse events (SAEs) were recorded during the trial, and incidence of treatment emergent adverse events (TEAEs) were mild to moderate in severity, in addition to being low and comparable between active treatment and the vehicle cream.

Common adverse events that affected over 1% of the study population included COVID-19, urinary tract infection, nasopharyngitis, and nausea.

“We are excited that investigational roflumilast foam demonstrated strong topline results in our pivotal Phase 3 trial, consistent with previously reported data. These results move us one step closer to providing a new treatment option for the millions of people suffering from seborrheic dermatitis,” said Patrick Burnett MD, PhD, FAAD, Chief Medical Officer at Arcutis. “We will now prepare an NDA for roflumilast foam for the treatment of seborrheic dermatitis to submit to the U.S. Food and Drug Administration (FDA).”

Arcutis intends to submit an NDA in the beginning of 2023.