Arcutis: New Phase 3 Data in Seborrheic Dermatitis Trial

 

• Study met its primary endpoint with 80% of individuals treated with roflumilast foam achieving Investigator Global Assessment (IGA) Success compared to 59% of patients treated with vehicle (P<0.0001)
• More than 60% of patients treated with roflumilast foam achieved an itch response at Week 8, with significant improvements at the 2-and 4-week assessments
• Statistically significant improvements compared to vehicle on all secondary endpoints including scaling and erythema (redness)
• Roflumilast foam was well-tolerated with no evidence of local irritation
• New drug application (NDA) submission anticipated in 1Q of 2023

https://www.biospace.com/article/releases/new-data-from-arcutis-stratum-pivotal-phase-3-trial-of-roflumilast-foam-0-3-percent-in-seborrheic-dermatitis-presented-at-european-academy-of-dermatology-and-venereology-eadv-congress/