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.
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