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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. MethodsMaterials: 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. |
