Clinical Efficacy and Safety of Methotrexate versus Hydroxychloroquine in Preventing Lichen Planopilaris Progress: A Randomized Clinical Trial

Abstract

Background: Lichen planopilaris is an inflammatory cicatricial alopecia, and its management is a challenge for dermatologists. We aimed to compare the efficacy of methotrexate and hydroxychloroquine on refractory lichen planopilaris. Methods: In a randomized clinical trial, 29patients were randomly allocated to receive either 15mg methotrexate/week or 200mg hydroxychloroquine twice a day for 6months. Side effects, symptoms/signs, and laboratory tests were assessed periodically. Lichen Planopilaris Activity Index(LPPAI) was measured before intervention and at 2, 4, and 6months after. The changes from baseline to the end of the study were analyzed within each group and between the two groups by per-protocol and intention-to-treat analysis. Results: After 2months, mean(standard deviationSD) decrease in LPPAI in methotrexate group was significantly more than that in hydroxychloroquine group(1.681.24 vs. 0.80.71, respectively, P=0.047). Furthermore, after 6months, mean(SD) decrease in LPPAI in methotrexate group was significantly higher than that in hydroxychloroquine group(3.32.09 vs. 1.510.91, respectively, P=0.01). The following symptoms/signs showed significant improvements in frequency and/or severity in methotrexate group after intervention: pruritus(P= 0.007), erythema(P= 0.01), perifollicular erythema(P= 0.01), perifollicular scaling(P= 0.08), spreading(P= 0.001), and follicular keratosis(P= 0.04). In hydroxychloroquine group, only erythema(P= 0.004) showed significant improvement. Conclusions: Methotrexate was more effective than hydroxychloroquine in treating refractory lichen planopilaris.