What type of study is this?

This is a Phase 2 study (also classified as: Observational).

September 10, 2025Open Access

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

Key Points

Roflumilast cream improved psoriasis symptoms in children aged 2-11 years, indicating clinical benefit.
In the trials, systemic exposure to the active metabolite was observed, confirming pharmacokinetics of roflumilast.
The treatment was well tolerated across both age groups, highlighting its safety profile in children.
Trial registration details confirm adherence to testing protocols and transparency in research.

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.

Read Full Paperexternally

Demander à l'IA

Bookmark

View Full Paper

Cite This Study

Hebert et al. (Wed,) studied this question.

synapsesocial.com/papers/68c1d5f754b1d3bfb60f90a2 https://doi.org/https://doi.org/10.1111/pde.70013

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

Demander à l'IA

Bookmark

View Full Paper