Paroxetine Effective for Refractory Erythema of Rosacea

Paroxetine therapy is associated with statistically significant, clinically meaningful efficacy and an acceptable safety profile in patients with moderate-to-severe erythema of rosacea, according to study findings published in Journal of the American Academy of Dermatology.

Researchers conducted a prospective, double-blind, randomized clinical trial to assess the efficacy and safety of paroxetine compared with placebo for moderate-to-severe erythema of rosacea. Study participants aged 18 to 65 years with refractory erythema of rosacea were recruited from 5 Chinese research centers between April 2020 and September 2021.

Participants were randomly assigned in a 1:1 ratio to receive paroxetine 25 mg daily or placebo for a 12-weeks. Study visits were scheduled at baseline and at weeks 4, 8, and 12. Participants who experienced therapeutic success were followed up for an additional 12 weeks for recurrence.

The primary efficacy endpoint was the proportion of participants who achieved Clinical Erythema Assessment (CEA) success, which was defined as scores of 0 or 1 or at least a 2-grade improvement at week 12 from baseline.

A total of 112 participants (paroxetine, n=58 [mean age, 31.71±10.884 years; 89.7% women; placebo, n=54 [mean age, 31.13±10.124 years; 92.6% women]) were randomly assigned. Among this group, 97 patients (paroxetine, n=49; placebo, n=48) completed the study.

The primary endpoint was achieved with CEA scores of 0 or 1 or at least a 2-point improvement for paroxetine vs placebo at week 12 compared with baseline (42.9% vs 20.8%, P =.02). Participants’ CEA scores showed similar decreases at weeks 4 and 8 in the paroxetine and placebo groups, and the paroxetine group had a significant decrease at 12 weeks (week 4, P =.653; week 8, P =.77).

Of 49 participants in the paroxetine group, 22 (44.9%) had improvement in flushing with point reductions of 2 or more (vs baseline) compared with 12 of 48 participants (25.0%) in the placebo group (P =.04). The overall flushing score improvement in self-assessments with visual analogue scales was 2.49±3.028 in the paroxetine group, which was significantly greater than that of 1.68±2.27 in the placebo group (P =.047).

Investigator’s Global Assessment (IGA) scores were not different between the 2 groups at 12 weeks (P =.71), and telangiectasia improvement was similar between groups at 12 weeks (P =.929). Burning sensation improved at least 2 points from baseline more frequently in the paroxetine group compared with the placebo group at week 12 (46.9% vs 18.8%; P =.003).

Recurrence was followed up in 21 participants with CEA success in the paroxetine group. During the 12-week follow-up, 16 participants completed the study, of whom 5 (31.2%) had recurrence and 2 relapsed to their initial CEA severity.

In the placebo-controlled period, 14 of 58 participants (24.1%) in the paroxetine group and 6 of 54 participants (11.1%) in the placebo group had at least 1 treatment-emergent adverse events (TEAEs; P =.072). In the paroxetine group, 1 of 58 (1.7%) participants had a severe TEAE (ie, tinnitus). In the placebo group, 2 of 54 (3.7%) participants had a severe TEAE (1 each of anemia exacerbation and drug allergy).

Limitations of the study include the fact that only a single-dosage regimen of paroxetine within a 12-week study was analyzed, and the relatively short follow-up for improved patients and the unknown long-term efficacy of paroxetine.

“Our results showed that the erythema response rate plateaued in the placebo group at week 8, whereas a linear increase was evident in that of the paroxetine group over the course of 12 weeks,” conclude the researchers. “This is an interesting clinical outcome, and we believe that the rate of erythema improvement will further increase with prolonged paroxetine treatment.”