Paroxetine is an effective treatment for refractory erythema of rosacea: Primary results from the Prospective Rosacea Refractory Erythema Randomized Clinical Trial

Background: Patients with refractory erythema of rosacea have limited treatment options.Objective: To evaluate the efficacy and safety of a 12-week course of paroxetine for moderate-to-severe erythema of rosacea.Methods: In a multicenter, randomized, double-blinded, placebo-controlled trial, patients with refractory erythema of rosacea were randomly assigned (1:1) to receive paroxetine 25 mg daily or placebo for 12 weeks.Results: Overall, 97 patients completed the study (paroxetine: 49; placebo: 48). The primary end point was the proportion of participants achieving Clinical Erythema Assessment success (defined as Clinical Erythema Assessment score of 0, 1, or & GE;2-grade improvement from baseline) at week 12; this was significantly greater in the paroxetine group than in the placebo group (42.9% vs 20.8%, P = .02). Some secondary end points were met, such as flushing success with point reductions & GE;2 (44.9% vs 25.0%, P = .04) and improvement in overall flushing (2.49 & PLUSMN; 3.03 vs 1.68 & PLUSMN; 2.27, P = .047), burning sensation (46.9% vs 18.8%, P = .003), and depression (P = .041). The most reported adverse events associated with paroxetine were dizziness, lethargy, nausea, dyspepsia, and muscle tremors. Limitations: Only a single-dosage regimen of paroxetine within a 12-week study was evaluated.Conclusions: Paroxetine is an effective and well-tolerated alternative treatment for moderate-to-severe erythema of rosacea. ( J Am Acad Dermatol 2023;88:1300-7.)

Automated summary

This study evaluated the efficacy and safety of a 12-week treatment with paroxetine for refractory erythema of rosacea. The results showed that the proportion of participants who achieved treatment success was significantly higher in the paroxetine group compared to the placebo group. Paroxetine also improved other symptoms and was well-tolerated. Paroxetine is an effective alternative treatment for moderate-to-severe erythema of rosacea.