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.

Two 4-week, phase 2, open-label, maximal usage pharmacokinetic (PK) and safety studies of once-daily roflumilast cream 0.3% (a potent phosphodiesterase 4 inhibitor) were conducted in children aged 2-5 years and 6-11 years with psoriasis. Evidence of systemic exposure to roflumilast and its active N-oxide metabolite was seen in most patients following daily application, consistent with previous studies. Under maximal use conditions, once-daily roflumilast cream 0.3% was well tolerated and improved signs and symptoms of psoriasis in children aged 2-11 years, consistent with phase 3 results in adults and adolescents. Trial Registration: Clinicaltrials.gov listing: 215: NCT04655313; 216: NCT04746911.