The following is a summary of “Paroxetine is an effective treatment for refractory erythema of rosacea: Primary results from the Prospective Rosacea Refractory Erythema Randomized Clinical Trial,” published in the JUNE 2023 issue of Dermatology by Wang, et al.
Limited treatment options exist for patients with refractory erythema of rosacea, a condition characterized by facial redness. For a study, researchers sought to evaluate the effectiveness and safety of a 12-week course of paroxetine for the treatment of moderate-to-severe erythema of rosacea.
A multicenter, randomized, double-blinded, placebo-controlled trial was conducted. Patients with refractory erythema of rosacea were randomly assigned in a 1:1 ratio to receive either daily paroxetine 25 mg or a placebo for 12 weeks.
Ninety-seven patients completed the study (paroxetine: 49; placebo: 48). At week 12, the primary endpoint, Clinical Erythema Assessment success (defined as Clinical Erythema Assessment score of 0, 1, or ≥2-grade improvement from baseline), was achieved by a significantly higher proportion of participants in the paroxetine group compared to the placebo group (42.9% vs. 20.8%, P = .02). Several secondary endpoints were also met: flushing success with point reductions ≥2 (44.9% vs. 25.0%, P = .04), improvement in overall flushing (2.49 ± 3.03 vs. 1.68 ± 2.27, P = .047), reduction in burning sensation (46.9% vs. 18.8%, P = .003), and improvement in depression (P = .041). Adverse events associated with paroxetine included dizziness, lethargy, nausea, dyspepsia, and muscle tremors.
The study only evaluated a single dosage regimen of paroxetine over 12 weeks. Paroxetine demonstrated effectiveness and tolerability as an alternative treatment for moderate-to-severe erythema of rosacea. The findings suggested that paroxetine may offer a viable option for patients with refractory erythema of rosacea, addressing an unmet need in this population.