Roflumilast Cream for Psoriasis in Children
Roflumilast Cream Shows Promise for Young Plaque Psoriasis Patients
New research suggests that roflumilast cream 0.3% might potentially be an effective treatment for improving the signs and symptoms of plaque psoriasis in children aged 2-11 years. The findings are consistent with previous phase 3 data in older patients.
Key Findings:
Effectiveness: The cream demonstrated potential for enhancement under maximal use conditions. Safety & Tolerability: The data on safety, how the body processes the drug (pharmacokinetics – PK), and tolerability were consistent with previous studies in patients aged 2 years and older.
Study Design: Two phase 2, open-label studies were conducted over 4 weeks, involving children aged 2-5 and 6-11 with plaque psoriasis. Participants needed at least 2% body surface area (BSA) affected and an Investigator Global Assessment (IGA) score of 2 or higher (on a scale of 0-4).
Application: Caregivers applied the cream once daily to affected skin for 28 days.
PK Assessment: Researchers assessed how the drug was absorbed and processed by the body (PK) at 4 weeks,with additional sampling at 2 weeks for those with more meaningful involvement (≥ 3% BSA,excluding palms,scalp,and soles).
Outcomes measured:
Primary: safety, PK, and tolerability. Exploratory (Efficacy):
IGA success (clear or almost clear skin with at least a 2-grade improvement).
≥ 75% improvement in psoriasis Area and Severity Index (PASI-75).
* ≥ 4-point reduction in Worst Itch-Numeric Rating Scale (WI-NRS).
Why this is significant:
Currently, there are limited topical treatments approved for children under 12 with psoriasis, despite the disease having a similar underlying cause in children and adults. This research offers hope for a new treatment option for this population.
Source: Hebert, A., et al. (Published in HCPLive – link provided in the original text).