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

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By Elana Gotkine HealthDay Reporter

Medically reviewed by Judith Stewart, BPharm. Last updated on March 13, 2026.

via HealthDay

FRIDAY, March 13, 2026 -- 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.

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Source: HealthDay

Posted : 2026-03-14 01:36

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