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Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients Aged 2-5 Years With Mild-to-Moderate

Lawrence F Eichenfield1, Rocco Serrao2, Vimal H Prajapati3

  • 1University of California San Diego, La Jolla, California, USA, Rady Children's Hospital - San Diego, San Diego, California, USA.

Pediatric Dermatology
|February 21, 2025
PubMed

Insights

Roflumilast cream 0.05% effectively treated atopic dermatitis (AD) in young children, showing significant symptom improvement and rapid itch relief. The treatment was well-tolerated with a low rate of adverse events.

Area of Science:

  • Dermatology
  • Pediatric Atopic Dermatitis
  • Topical Anti-inflammatory Agents

Background:

  • Atopic dermatitis (AD) is a chronic inflammatory skin condition affecting children.
  • Previous studies demonstrated the efficacy of roflumilast cream 0.15% in patients aged 6 years and older.
  • This study investigated a lower concentration (0.05%) in a younger pediatric population.

Purpose of the Study:

  • To evaluate the efficacy and safety of once-daily roflumilast cream 0.05% in children aged 2-5 years with mild-to-moderate atopic dermatitis (AD).
  • To compare roflumilast cream 0.05% against a vehicle control.
  • To assess improvements in AD signs, symptoms, and pruritus.

Main Methods:

  • A Phase 3, parallel-group, double-blind trial (INTEGUMENT-PED; NCT04845620) involving 2-5 year olds with mild-to-moderate AD.
  • Participants received once-daily roflumilast cream 0.05% or vehicle for 4 weeks.
  • Primary endpoint: Validated Investigator Global Assessment for AD (vIGA-AD) Success. Secondary endpoints included Eczema Area and Severity Index (EASI-75) and Worst Itch-Numeric Rating Score (WI-NRS) Success.

Main Results:

  • Significantly higher proportions of patients achieved vIGA-AD Success (25.4% vs. 10.7%) and EASI-75 (39.4% vs. 20.6%) with roflumilast compared to vehicle (p < 0.0001).
  • Roflumilast cream demonstrated rapid improvement in pruritus within 24 hours of the first application (nominal p = 0.0014).
  • Treatment-emergent adverse event rates were low (98.9% mild or moderate), with minimal local tolerability issues (stinging/burning ≤ 0.7%).

Conclusions:

  • Once-daily roflumilast cream 0.05% is an effective treatment for improving AD signs and symptoms in children aged 2-5 years.
  • The study highlights early pruritus relief and a favorable safety profile, with local tolerability comparable to the vehicle.
  • Roflumilast cream 0.05% represents a promising therapeutic option for pediatric atopic dermatitis.
Abstract

Keywords:
atopic dermatitiseczemanonsteroidal topicalpediatricspruritusroflumilast

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