Roflumilast Cream Has Long-Term Safety, Efficacy in Young Children

FRIDAY, March 13, 2026 (HealthDay News) -- For children aged 2 to 5 years with atopic dermatitis (AD), roflumilast cream 0.05 percent has a favorable long-term safety profile and efficacy for up to 56 weeks, according to a study published online March 8 in Pediatric Dermatology.Lawrence F. Eichenfield, M.D., from the University of California-San Diego School of Medicine, and colleagues examined the long-term outcomes of continuing roflumilast cream for ≤56 weeks in a phase 3 open-label extension of the INTEGUMENT-PED trial (INTEGUMENT-OLE) conducted among children aged 2 to 5 years with mild-to-moderate AD. Roflumilast cream 0.05 percent was applied once daily in INTEGUMENT-OLE; application was switched to twice weekly in patients who achieved Validated Investigator Global Assessment for AD (vIGA-AD) clear (0) at/after week 4 of INTEGUMENT-OLE.The researchers found that 14 (2.5 percent) of the 562 patients had treatment-related adverse events (AEs). Roflumilast was well tolerated; four patients (0.7 percent) reported application-site pain AEs. AD signs/symptoms continued to improve at treatment week 56 (63.1 percent of patients achieved vIGA-AD 0/1). The median duration of disease control was 238 days among the 170 patients (30.2 percent) who switched to twice-weekly application."Providing safe, effective nonsteroidal treatment options for young patients -- who can have substantial disease burden but have limited available therapies -- remains an important goal in pediatric dermatology," Eichenfield said in a statement. "The publication of these data reinforces Zoryve cream 0.05 percent as a meaningful, long-term treatment option for children living with atopic dermatitis and their families."Several authors disclosed ties to biopharmaceutical companies, including Arcutis Biotherapeutics, which manufactures roflumilast and funded the study.Abstract/Full Text.Sign up for our weekly HealthDay newsletter

Roflumilast Cream Has Long-Term Safety, Efficacy in Young Children

Related Stories

Risk for Long COVID Increased With Autoimmune Rheumatic Diseases

Benzodiazepine Use in Pregnancy Not Tied to Congenital Malformations

Ruxolitinib Cream Shows Promise in Reducing Lesions, Itch With Cutaneous Lichen Planus

Unintentional Ingestion of Recreational Drugs Increased, Especially Since 2013