A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis
Latest Information Update: 13 Jan 2024
At a glance
- Drugs Roflumilast (Primary)
- Indications Seborrhoeic dermatitis
- Focus Proof of concept; Therapeutic Use
- Sponsors Arcutis Biotherapeutics
Most Recent Events
- 08 Jan 2024 According to an Arcutis Biotherapeutics media release, based on results from STRATUM and the Phase 2 Trial 203, the Health Canada has accepted for review the Supplement to a New Drug Submission (SNDS) for roflumilast foam 0.3%, a steroid-free, once-daily phosphodiesterase-4 (PDE4) inhibitor for the topical treatment of seborrheic dermatitis in adult and adolescent patients 9 years of age and older.
- 15 Dec 2023 According to an Arcutis Biotherapeutics media release, based on results from STRATUM and the Phase 2 Trial 203, the U.S. Food and Drug Administration (FDA) has approved the new drug application (NDA) for ZORYVE (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older.
- 03 May 2023 Results assessing safety and efficacy of roflumilast foam in seborrheic dermatitis patients were published in the JAMA Dermatology