Oxymetazoline and Energy‐Based Therapy in Patients with Rosacea: Evaluation of the Safety and Tolerability in an Open‐Label, Interventional Study

Abstract

Background and Objectives The objectives of this study were to evaluate the safety, tolerability, and efficacy of oxymetazoline hydrochloride cream, 1% (oxymetazoline) when used as an adjunctive treatment with energy‐based therapy for patients with moderate to severe facial erythema associated with rosacea. Study Design/Materials and Methods In this Phase 4, multicenter, interventional, open‐label study, eligible patients received one of four energy‐based therapies (potassium titanyl phosphate laser, intense pulsed light therapy, pulsed‐dye laser Vbeam Perfecta, or pulsed‐dye laser Cynergy) on day 1 and day 29 and once‐daily application of oxymetazoline on days 3 through 27 and days 31 through 56. Improvement from baseline in Clinician Erythema Assessment (CEA) score, patient satisfaction measures, incidence of treatment‐emergent adverse events (TEAEs), and worsening from baseline on dermal tolerability assessments and the Clinician Telangiectasia Assessment (CTA) were assessed. Data were summarized using descriptive statistics. Results A total of 46 patients (mean age, 51.1 years; 78.3% female) enrolled in this study. Similar numbers of patients received each of the energy‐based therapies in addition to oxymetazoline. All patients demonstrated an improvement from baseline in CEA during the study with 39 of 43 evaluable patients (90.7%) demonstrating an improvement 6 hours posttreatment on day 56. Most patients were satisfied or very satisfied with treatment at the end of the study. All TEAEs were mild or moderate in severity. Some patients experienced worsening in dermal tolerability assessment symptoms (range: 4–21 patients; 8.7–45.7%). Worsening in CEA and CTA were each reported by three patients (6.5%) at any time during the study. Conclusions Treatment with oxymetazoline as adjunctive therapy with energy‐based therapy was safe, well tolerated, and reduced facial erythema in patients with moderate to severe persistent facial erythema associated with rosacea. Lasers Surg. Med. © 2020 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC

Rosacea Treatment: Review and Update

“…The combination of laser-and light-based therapies and other therapies has also been investigated in recent studies. The findings of a phase 4, multicenter, interventional, open-label study with 46 patients suggest the benefit of oxymetazoline as adjunctive therapy with energy-based therapy for the treatment of moderate to severe persistent facial erythema associated with rosacea [54]. A retrospective study including 31 subjects revealed that the combination of pulsed dye laser and 1.0% oxymetazoline cream reduced erythema and telangiectasias both safely and effectively [55].…”

“…Combination therapy to target specific features is necessary to achieve effective treatment, especially in patients with severe rosacea or multiple rosacea features [13,14]. Oral therapy combined with topical therapy [83], laser-/lightbased therapy combined with topical therapy [54], and a combination of topical therapies [84] have all been documented in recent publications. Fractional microneedling radiofrequency, a new device in dermatology, has also been used to treat recalcitrant papulopustular rosacea combined with pulsed dye laser and oral isotretinoin [85].…”

Updates and Best Practices in the Management of Facial Erythema

“…3 Use of oxymetazoline as adjunctive therapy with potassium-titanyl-phosphate (KTP) lasers, 595nm pulse dye laser (PDL), and IPL has been demonstrated to be well tolerated and efficacious in further helping to reduce facial erythema. 12 , 13 …”

Xylometazoline and oxymetazoline - unusual effects of everyday drugs (literature review)

“…[10] [11] In addition, the application of oxymetazoline in cream form as adjunctive therapy has been evaluated as safe and well tolerated, and reduces facial erythema in patients with moderate to severe facial erythema associated with rosacea. [12] Based on current research, topical alpha-adrenergic receptor agonist therapies have been shown to be safe and effective and are currently the only agents offered specifically for facial erythema associated with rosacea. Topical 1% oxymetazoline should now be included in the arsenal of medications for facial erythema in rosacea, as data suggest that it is an effective alternative with minimal side effects compared to previously approved topical medications.…”