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. 2025 Aug 27.
doi: 10.1111/pde.70013. Online ahead of print.

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

Adelaide A Hebert  1 , Shireen V Guide  2 , Vlada Groysman  3 , Mercedes E Gonzalez  4 , Daisy Blanco  5 , Vivian Laquer  6 , Melissa S Seal  7 , Archie Thurston  7 , David Krupa  7 , Scott Snyder  7 , Patrick Burnett  7 , David H Chu  7 , David R Berk  7 , Robert C Higham  7
Affiliations

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

Adelaide A Hebert et al. Pediatr Dermatol. .

Abstract

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.

Keywords: children; pharmacokinetics; psoriasis; roflumilast cream 0.3%; topical treatment.

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References

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