Roflumilast Cream 0.3% Effective for Psoriasis in Children Aged 2 to 11 Years

Roflumilast cream 0.3% may improve signs and symptoms of plaque psoriasis among patients aged 2 - 11 years under maximal use conditions, new findings suggest.1

These data on the overall safety, pharmacokinetics (PK), tolerability, and effectiveness were consistent with prior phase 3 data in studies that had evaluated patients aged ≥ 2 years and maximal usage results in patients in the ≥ 12-year age range. Adelaide Hebert, MD—professor and director of pediatric dermatology with McGovern Medical School at UTHealth Houston—authored this new analysis alongside a team of other investigators.

“The pathogenesis of psoriasis is similar in children and adults, although few topical treatments are approved for children aged < 12 years,” Hebert et al wrote.1,2 “Efficacy and safety of once-daily roflumilast cream 0.3%, a phosphodiesterase 4 inhibitor, have been demonstrated in phase 3 trials enrolling patients aged ≥ 2 years with psoriasis.”

Trial Design Details

The investigative team highlighted a pair of phase 2, open-label, maximal usage analyses. These 2 analyses evaluated roflumilast cream 0.3% as a treatment for children living with plaque psoriasis, with each study taking place over the course of 4 weeks and involving participants aged 2 - 5 years and aged 6 - 11 years.

Hebert and colleagues highlighted that requirements for eligibility were having at least 2% body surface area (BSA) and an Investigator Global Assessment (IGA) score of ≥ 2, where scores range from 0 (clear) to 4 (severe). The investigators highlighted that caregivers administered roflumilast cream to once-per-day to participants' affected skin for 28 days.

The investigative team conducted assessments of subjects' PK at the 4-week mark for all trial participants. There was additional sampling at the 2-week mark in the maximal usage subgroups (defined as ≥ 3% BSA involvement excluding the palms, scalp, and soles).

The team estimated systemic exposure by extrapolating AUC0–24 values, calculated from predose plasma concentrations. They were then cross-checked with serial PK samples that had been gathered at the 2-week mark (pre-dose, 2, 4, and 6 hours post-dose) from one representative patient in each study.

The primary outcomes that Hebert and coauthors looked at included safety, PK, and tolerability. Exploratory efficacy outcomes in these studies assessed IGA success, defined as attaining a rating of clear or almost clear plus a ≥ 2-grade improvement.

Other efficacy outcomes included attainment of ≥ 75% improvement in Psoriasis Area and Severity Index (PASI-75) and success in the Worst Itch–Numeric Rating Scale (WI-NRS), defined as a ≥ 4-point reduction among those with baseline scores ≥ 4; self-reported for those ≥ 8 years old, caregiver-reported for those < 8 years. They also evaluated any shifts in BSA involvement and Children’s Dermatology Life Quality Index (CDLQI) scores.

Findings on Roflumilast Cream 0.3%

Overall, the results analyzed by Hebert and colleagues demonstrated measurable systemic absorption of roflumilast and its active N-oxide metabolite in most of the trial participants. Such conclusions aligned with prior phase 3 data on roflumilast cream, investigators noted.

For those in the age 2 - 5 year age bracket, 90% attained success in IGA, 90% attained PASI-75, and 90% attained WI-NRS success at the 4-week mark. Those aged 6 - 11 years also saw significant results, with 40% having IGA success, 50% attaining a PASI-75 score, and 40% reaching WI-NRS success at the same 4-week time point.

Hebert et al further noted that mean BSA involvement reductions had been 79.1% in subjects aged 2 - 5 years of age and 44.4% in those aged 6 - 11 years at the 4-week mark. They also highlighted that 65% of those aged 2 - 5 years demonstrated improvement in CLDQI scores and that 90% of those aged 6 - 11 years saw CLDQI improvements.

“Roflumilast cream 0.3% was well tolerated and improved signs and symptoms of psoriasis in patients aged 2–11 years under maximal use conditions,” the investigators concluded.1 “Despite the small sample size, overall PK, safety, tolerability, and efficacy were consistent with phase 3 results in patients aged ≥ 2 years and maximal usage results in patients aged ≥ 12 years.”

References

1. AA Hebert, SV Guide, V Groysman, et al. “ 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,” Pediatric Dermatology (2025): 1–4, https://doi.org/10.1111/pde.70013.

2. Lebwohl MG, Kircik LH, Berk DR, et al. Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials. JAMA. 2022 Sep 20;328(11):1073-1084. doi: 10.1001/jama.2022.15632. PMID: 36125472; PMCID: PMC9490499.