Roflumilast Cream 0.3% Safe and Effective for Plaque Psoriasis in Children Aged 2–11 Years: Study

A new study published in the journal of Pediatric Dermatology found that under optimal usage settings, roflumilast cream 0.3% was safe, well-tolerated, and effective in reducing plaque psoriasis signs and symptoms in children ages 2 to 11.

A new nonsteroidal treatment with the potential to effectively manage illness and provide good safety is roflmilast cream 0.3%, a selective phosphodiesterase-4 (PDE4) inhibitor. When given once daily to children with mild to moderate plaque psoriasis aged 2-11 years, recent phase 2 trials have offered preliminary insights into its pharmacokinetics, therapeutic advantages, and tolerability.

Children with plaque psoriasis were the subjects of the trials that assessed roflumilast cream 0.3%. Trial 215 recruited patients aged 6–11 years (N=20; approvals June 26, 2020, and February 4, 2021), whereas Trial 216 was open to patients aged 2–5 years (N=10; protocol approvals August 24, 2020, and March 2, 2021).

The patients who were eligible had an Investigator Global Assessment (IGA) score of at least two and a body surface area (BSA) involvement of at least 2%. For 28 days, caregivers administered roflumilast once daily to the afflicted regions. All subjects underwent pharmacokinetic (PK) sample at Week 4, while maximum use subgroups (≥3% BSA involvement, excluding scalp, palms, and soles) underwent PK sampling at Week 2.

Predose plasma concentrations were used to derive extrapolated AUC0–24 values, which were then confirmed in a subset of patients by serial PK sampling. Tolerability, safety, and PK were the main endpoints. IGA success, PASI-75, itching reduction (WI-NRS), BSA change, and the Children's Dermatology Life Quality Index (CDLQI) were among the endpoints used to assess exploratory effectiveness.

In line with earlier research, the majority of patients showed signs of systemic exposure to roflumilast and its active N-oxide metabolite after daily use. Once-daily roflumilast cream 0.3% was well tolerated under maximal usage settings and improved psoriasis signs and symptoms in children ages 2–11, which is in line with phase 3 outcomes in adults and adolescents.

Overall, under optimal usage settings, roflumilast cream 0.3% was well tolerated and reduced psoriasis signs and symptoms in individuals ages 2–11. Overall PK, safety, tolerability, and effectiveness were in line with phase 3 results in patients aged ≥2 years and maximal use outcomes in patients aged ≥12 years, despite the small sample size.

Source:

Hebert, A. A., Guide, S. V., Groysman, V., Gonzalez, M. E., Blanco, D., Laquer, V., Seal, M. S., Thurston, A., Krupa, D., Snyder, S., Burnett, P., Chu, D. H., Berk, D. R., & Higham, R. C. (2025). Early evidence of safety, clinical benefit, and pharmacokinetics of roflumilast cream 0.3% once daily for treatment of mild or moderate plaque psoriasis in children aged 2–11 years. Pediatric Dermatology,. https://doi.org/10.1111/pde.70013