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Energy-based therapy plus oxymetazoline improved erythema.

ENERGY-BASED therapy with adjunctive oxymetazoline was safe and improved facial erythema for patients with moderate to severe facial erythema associated with rosacea, in an open-label, phase 4 study.

The study evaluated energy-based therapy with oxymetazoline cream (1%) in 46 patients with rosacea, who had moderate to severe facial erythema. They were treated with one of four energy-based devices: pulseddye laser Vbeam Perfecta (PDL-Vbeam), pulsed-dye laser Cynergy (PDL-Cynergy), intense pulsed-light therapy (IPL), or potassium titanyl phosphate laser (KTP laser), plus oxymetazoline. On days 3-27 and 3156, oxymetazolinewas applied once daily; energy-based therapy was provided on day 1 and day 29.

The exploratory efficacy endpoint was the clinician erythema assessment (CEA) score from start of therapy measured over a 6-hour period post treatment. Among the 43 patients who completed the study, the CEA score was improved in 39 (90.7%) patients 6 hours post treatment on day 56 and in 30 (68.2%) patients pretreatment, reported Emil A. Tanghetti, MD, of the Center for Dermatology and Laser Surgery in Sacramento, and coauthors. On day 31, "one-grade or greater improvement was observed" in 26 (60.5%) patients before application of oxymetazoline, and in 38 (88.4%) of patients 6 hours post treatment.

Overall, patient satisfaction increased during the study, with 28 (65.1%) of patients reporting they were satisfied or very satisfied with the treatment on day 56.

Among 46 patients who received at least one treatment, 5 (10.9%) had one or more treatment-emergent adverse events; all were considered mild or moderate. Three (6.5%) patients had oxymetazoline-related adverse events and discontinued the study.

The researchers acknowledged that a key limitation of the study was the use of multiple devices, delivered by different providers, which could have caused inconsistency in the results. "Prospective clinical studies assessing the long-term safety and efficacy of combined treatment with oxymetazoline and energy-based therapies are needed," they wrote.

The manuscript was funded by oxymetazoline manufacturer Aclaris. Several authors disclosed being an investigator, consultant, and /or adviser for laser manufacturers. One author was an Aclaris employee.



SOURCE: Tanghetti EA et al. Lasers Surg Med. 2020 May 6. doi: 10.1002/ lsm.23253.

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Title Annotation:ROSACEA
Author:Rans, Caleb
Publication:Dermatology News
Date:Jun 1, 2020
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