Safety and Effectiveness of Microfocused Ultrasound for Treating Erythematotelangiectatic Rosacea

June 2019 | Volume 18 | Issue 6 | Original Article | 522 | Copyright © June 2019

Joel Schlessinger MD,a Mark Lupin MD FRCPC,b David McDaniel MD,c Rosalyn George MDd

aSkin Specialists PC, Omaha, NE bCosmedica Laser Center, Victoria, BC Canada cLaser & Cosmetic Center, Virginia Beach, VA dWilmington Dermatology Center, Wilmington, NC

Abstract
Background: Anecdotal reports indicate the use of microfocused ultrasound with visualization (MFU-V) improves facial redness.

Objective: The purpose of this pilot study was to assess the safety and effectiveness of MFU-V for improving the signs and symptoms of erythematotelangiectatic rosacea.

Methods & Materials: Healthy adults with a clinical diagnosis of erythematotelangiectatic rosacea were enrolled (N=91). Eligible subjects had baseline Clinician Erythema Assessment (CEA) scores ≥3 and Patient Self-Assessment (PSA) of erythema scores ≥2. Subjects were randomized to receive one or two low-density MFU-V treatments or one or two high-density MFU-V treatments. Subjects were evaluated at 90, 180, and 365 days after treatment. The primary effectiveness endpoint was treatment success, defined as a 1-point change in CEA scores at 90 days post-treatment.

Results: Across groups, 75 to 91.3% of subjects achieved treatment success at 90 days post-treatment. Notable adverse events include bruising (44%), tenderness/soreness (43%), and redness (35%). Treatment results were sustained, lasting up to 1 year. Subject satisfaction was high based on self-assessment questionnaires.

Conclusion: The results of this study demonstrated that a single, high-density MFU-V treatment may be effective for treating erythematotelangiectatic rosacea. Based on these results, a large, randomized controlled study of single, high-density MFU-V treatment for erythematotelangiectatic rosacea is warranted.

J Drugs Dermatol. 2019;18(6):522-531.

INTRODUCTION

Rosacea is a chronic, cutaneous inflammatory syndrome that most commonly affects the convexities of the central face, including the cheeks, chin, nose, eyes, and central forehead. Often characterized by remissions and exacerbations, it manifests as various combinations of cutaneous flushing, erythema, telangiectasia, edema, papules, pustules, ocular lesions and rhinophyma.1 Individuals are typically affected by some, but not all, of these characteristics, based on the form of rosacea they encounter.

The different forms of rosacea include erythematotelangiectatic (ETT), papulopustular (PP), phymatous, and ocular.2 The causes of rosacea are poorly understood, but appear to involve chronic inflammation, environmental triggers, ingested foods, and microorganisms, either alone or in combination.2 Although it occurs primarily among elderly, fair-skinned individuals, the prevalence of rosacea is poorly characterized. Estimates range from 5% in the US and Russia3,4 to 10-13% in Sweden and Germany.1,4 The primary clinical feature of ETT rosacea is transient or persistent facial erythema which, if left untreated, may progress to disfiguring papules or pustules.5,6 Consequently, patients with rosacea have a higher incidence of social embarrassment, social anxiety, depression, stigmatization and decreased self-esteem5, 7-9 leading to diminished quality of life.5,10-12

The only FDA-approved systemic agent for treating rosacea is a modified-release doxycycline product.13 This agent is only indicated for the treatment of inflammatory papules and pustules associated with rosacea in adult patients. It is not effective for treating generalized erythema.13 Carvedilol, a nonselective β-blocker with α-1 blocking activity, has been used off-label to treat erythema and flushing.14 Other systemic agents, which are used off-label, for treating rosacea-related papules and pustules include tetracyclines, macrolides, metronidazole, and isotretinoin.14

Azelaic acid gel is FDA-approved for the topical treatment of inflammatory papules and pustules of mild-to-moderate rosacea; however, the efficacy of this product for treating erythema in the absence of papules and pustules has not been evaluated.15 The only FDA-approved topical product for persistent facial flushing is brimonidine tartrate gel, an α-2 agonist,16 while topi