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Paroxetine found to be effective for refractory erythematous rosacea

13th July 2023

Paroxetine is effective for erythematous rosacea which failed to respond to at least three months of tetracycline treatment or intense pulsed light therapy, according to a recent, randomised placebo-controlled trial.

In a previous study, the antidepressant paroxetine was shown to be effective for menopausal hot flushes, which suggests an anti-inflammatory effect. Here, Chinese researchers sought to evaluate the efficacy and safety of a 12-week course of paroxetine for moderate-to-severe erythema of rosacea.

The primary outcome was the proportion of participants achieving a Clinical Erythema Assessment (CEA) success, which was defined a CEA score of 0 (clear) or 1 (almost clear) or at least a two-grade or higher improvement in CEA score from baseline after 12-weeks treatment.

As rosacea is associated with facial flushing, the team also used a Flushing Assessment Tool, with success defined by a >2-point improvement and a self-reported overall flushing score (ranging from 0-10).

Additional secondary outcomes examined the level of skin burning, depression and the impact on a rosacea quality of life tool.

Paroxetine and clinical erythema

A total of 97 patients were enrolled and 49 were randomised to paroxetine 25 mg and the remainder to a placebo for a total of 12 weeks.

After 12 weeks, significantly more patients given paroxetine achieved the primary outcome (42.9% vs 20.8%, p = 0.02). In addition, there was a significant improvement in flushing success (p = 0.04) and an improvement in overall flushing score (2.49 vs 1.68, p = 0.047).

Participants taking paroxetine also reported significant reductions in skin burning (p = 0.003) and depression (p = 0.041) compared to placebo. However, there was no significant differences in the extent to which telangiectasia improved between the two groups (p = 0.93) or in rosacea Quality of Life scores (p = 0.83).

During the study, treatment-emergent adverse events (TEAEs) occurred in 24.1% of paroxetine patients and in 11.1% of the placebo group. For the paroxetine group, these TEAEs included dizziness (10.3%), lethargy (10.3%), nausea (8.6%), dyspepsia (6.9%) and muscle tremors (5.2%).

Following cessation of therapy, the team also considered disease recurrence. Although only 21 patients were included in the 12-week follow-up, among the 16 who participated in a face-to-face interview, five (31.2%) reported disease recurrence and two relapsed to their initial CEA severity.

The researchers concluded that paroxetine is an effective and well-tolerated alternative treatment for moderate-to-severe erythema of rosacea.