Roflumilast Cream 0.05 Percent Safe, Effective in Young Children With Eczema
By Lori Solomon HealthDay Reporter
FRIDAY, March 14, 2025 -- Once-daily roflumilast cream 0.05 percent is safe and effective for atopic dermatitis (AD) in patients ages 2 to 5 years, according to a study published online Feb. 20 in Pediatric Dermatology.
Lawrence F. Eichenfield, M.D., from the University of California San Diego in La Jolla, and colleagues conducted a phase 3 trial evaluating the efficacy and safety of roflumilast cream 0.05 percent among patients ages 2 to 5 years with AD. The analysis included 437 patients randomly assigned to receive roflumilast and 215 patients randomly assigned to vehicle cream.
The researchers found that significantly greater proportions of participants in the roflumilast group achieved Validated Investigator Global Assessment for AD Success at week 4 (25.4 versus 10.7 percent), 75 percent improvement in the Eczema Area and Severity Index (39.4 versus 20.6 percent), and Worst Itch-Numeric Rating Score Success (35.3 versus 18.0 percent). Within 24 hours after the first application, improvement in pruritus was seen. Both groups had low rates of treatment-emergent adverse events, of which 98.9 percent were mild or moderate. Caregivers of patients in the roflumilast group reported stinging/burning that caused definite discomfort (≤0.7 percent) at all time points.
"These results suggest roflumilast cream 0.05 percent may provide a novel topical treatment option for patients aged 2 to 5 years with mild-to-moderate AD," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Arcutis Biotherapeutics, which manufactures roflumilast and funded the study.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted March 2025
Read this next
Early-Onset Pediatric Atopic Dermatitis Tied to Higher Risk for Uveitis
WEDNESDAY, April 23, 2025 -- Children with early-onset atopic dermatitis (AD) have an elevated risk for pediatric uveitis, according to a study published online April 3 in...
American Academy of Dermatology, March 7 to 11
The annual meeting of the American Academy of Dermatology was held from March 7 to 11 in Orlando, Florida, and attracted clinicians, academicians, allied health...
AAD: Maintenance of Low Eczema Activity Seen After About 80 Days Off Tapinarof
FRIDAY, March 14, 2025 -- Patients with atopic dermatitis (AD) who achieve completely clear skin with tapinarof (Vtama) cream maintain low disease activity after about 80 days off...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.