Roflumilast Phase 2 Results for Children Consistent With Phase 3 Adult Trials

Once-daily roflumilast cream 0.3% was well tolerated and improved signs and symptoms of psoriasis in children 2 to 11 years old in two 4-week, phase 2, open-label, maximal usage pharmacokinetic and safety studies, according to an article published in Pediatric Dermatology.

The results, consistent with phase 3 results in adults and adolescents, were published in an article titled, “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.”

Investigators saw evidence in most patients of systemic exposure to roflumilast and its active N-oxide metabolite following daily application, consistent with previous studies.