Efficacy of 0.5% Timolol Maleate Eye Drops for the Treatment of Facial Rosacea: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial Publisher Pubmed



Moradi A ; Shakoei S ; Hamzelou S ; Nasimi M ; Shahbazi T ; Ayatollahi A
Source: Journal of Dermatology Published:2026

Abstract

Rosacea is a chronic skin condition with limited effective and well-tolerated treatment options. This study investigated the efficacy of 0.5% timolol maleate eye drops in treating facial rosacea lesions. A randomized, triple-blind, placebo-controlled clinical trial was conducted at Razi Hospital in Tehran, involving 42 participants diagnosed with erythematotelangiectatic rosacea (ETR). Participants were randomized to receive either 0.5% timolol maleate eye drops or a placebo (distilled water) administered once daily for 4 weeks. The participants were evaluated in three visits (at baseline, after 4 weeks of treatment, and 4 weeks after stopping treatment) using a Mexameter MX18 device (for lightness and erythema), Clinician Erythema Assessment Scale (CEA), Global Flushing Severity Score (GFSS), Patient Self-Assessment (PSA), and Visioface device (for ΔL and ΔE criteria). The primary outcome was the change in erythema severity, assessed by the Mexameter MX18 device. The timolol group significantly reduced Erythema Index (p < 0.001) and other secondary outcomes, including CEA, PSA, and GFSS. No significant adverse effects were reported. In addition, MANOVA revealed a significant time × group interaction across outcomes, indicating that the pattern of changes over time was significantly different between the intervention and placebo groups. This study provides preliminary evidence that 0.5% timolol eye drops could be an effective and well-tolerated treatment for facial rosacea. However, the small sample size and short follow-up duration limited our results. © 2026 Japanese Dermatological Association.