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Efficacy of Paroxetine in the Treatment of Patients With Refractory Erythema of Rosacea
TAKE-HOME MESSAGE
- In this prospective, double-blind, randomized clinical trial, the outcomes of paroxetine 25 mg daily were compared with those of placebo in patients with refractory erythema of rosacea. At week 12, patients in the paroxetine group had significant improvements in erythema, flushing, and burning sensations. Dizziness, dyspepsia, lethargy, muscle tremors, and nausea occurred in approximately 5% to 10% of the patients receiving paroxetine.
- Paroxetine, and potentially other psychotropic medications acting on the serotonin pathway, are promising treatment options for refractory erythema of rosacea.
abstract
This abstract is available on the publisher's site.
Access this abstract now Full Text Available for ClinicalKey SubscribersBACKGROUND
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 endpoint was the proportion of participants achieving Clinical Erythema Assessment (CEA) success (defined as CEA score of 0, 1 or ≥ 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=0.02). Some secondary endpoints were met, such as flushing success with point reductions ≥2 (44.9% vs. 25.0%, p = 0.04) and improvement in overall flushing (2.49 ± 3.03 vs. 1.68 ± 2.27, P=0.047), burning sensation (46.9% vs. 18.8%, P=0.003), and depression (P=0.041). 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.
CONCLUSION
Paroxetine is an effective and well-tolerated alternative treatment for moderate-to-severe erythema of rosacea.
Additional Info
Disclosure statements are available on the authors' profiles:
Paroxetine is an effective treatment for refractory erythema of rosacea: primary results from the PRRERCT (Prospective Rosacea Refractory Erythema Randomized Clinical Trial)
J Am Acad Dermatol 2023 Feb 14;[EPub Ahead of Print], B Wang, Y Huang, Y Tang, Z Zhao, W Shi, D Jian, F Liu, Q Gao, P Wang, J Yang, L Li, H Xie, J LiFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Rosacea has many different clinical features, including inflammatory papules, pustules, centrofacial erythema, flushing, telangiectasia, and phyma. Some, or all, of these features may be present in any given patient. Unfortunately, available treatments are very specialized and typically target only one of these features. For example, we have many medications available that target inflammatory papules and pustules. These same agents often leave the background erythema and flushing untouched. While we do have topical alpha agonists approved to treat persistent facial erythema of rosacea, we currently have no FDA-approved oral medications for the erythema of rosacea. Aside from “off-label” use of beta blockers, we have no real oral alternatives for this bothersome feature of rosacea.
Paroxetine, an SSRI, is hypothesized to treat vascular dysfunction and has been studied for menopausal hot flashes. This study evaluated the efficacy and safety of paroxetine 25 mg QD vs placebo for 12 weeks for the refractory erythema of rosacea. And it worked. All 97 of the enrolled subjects had moderate to severe erythema at the outset. At week 12, 43% of those in the paroxetine arm had erythema scores of clear or almost clear compared to 21% with placebo (P = .02). Interestingly, it did take the full 12 weeks to see a statistical separation from placebo. Our approved topical alpha agonists have an onset and statistical improvement within hours of the first application. There was also statistically significant improvement in flushing with paroxetine vs placebo. Side effects included dizziness, lethargy, nausea, dyspepsia, and muscle tremors.
These early results look promising. We certainly need more treatment options for the erythema of rosacea, and I hope larger studies will follow. Prescribing SSRIs is not commonplace in the dermatology clinic, and we (I) will need to sharpen our knowledge and skills about the safe prescribing of these agents before we trial them in our patients. I look forward to learning more.