Oral Roflumilast in Lichen Planus: A Prospective Real-World Case Series of Ten Adults

Lichen planus (LP) is a chronic inflammatory dermatosis with limited systemic treatment options, and prospective data on oral phosphodiesterase-4 (PDE4) inhibition are lacking. We conducted a prospective real-world case series of ten adults with clinically and/or histologically confirmed LP treated with oral roflumilast, assessing disease severity using the Investigator's Global Assessment (IGA), pruritus and sleep disturbance using Numeric Rating Scales (NRS) and quality of life using the Dermatology Life Quality Index (DLQI). At baseline, 90% of patients presented moderate-to-severe disease (IGA 3-4). By week 12, 7 of 9 evaluable patients (78%) achieved IGA 0-1, increasing to 6 of 7 evaluable patients (86%) at week 24. Mean pruritus NRS improved from 7.7 to 1.6, sleep disturbance NRS from 7.3 to 2.0 and DLQI from 12.0 to 3.6. Overall, eight patients (80%) achieved at least 75% clinical improvement and six (60%) complete remission. The most frequent adverse events were insomnia (50%) and loose stools (30%), and two patients (20%) discontinued treatment because of adverse events. These preliminary prospective real-world findings suggest that oral roflumilast may represent a potential therapeutic option for LP and support further controlled studies to define the role of PDE4 inhibition and optimal dosing in this condition.