A microfocused ultrasound system with visualization (MFU-V) is currently indicated for use as a noninvasive dermatological aesthetic treatment to lift the eyebrows, lax submental and neck tissue, and improve lines and wrinkles of the décolleté.
To determine the existence of any safety signals when combining MFU-V with botulinum toxin-A and/or semipermanent and temporary dermal fillers.
A retrospective chart review was performed using subjects who received aesthetic treatments including incobotulinumtoxinA injection, cohesive polydensified matrix hyaluronic acid (CPM HA) dermal fillers, and calcium hydroxylapatite (CaHA) dermal fillers within 6 months of treatment with MFU-V in the same or different anatomic areas.
All subjects (N = 101; 96 female; 25–70 year old) received MFU-V, 18% received incobotulinumtoxinA injections, and 81% were treated with CPM HA and/or CaHA fillers. Seven adverse events (7%) were reported: bruising/purpura (n = 4), swelling (n = 1), paresthesia (n = 1), and herpes simplex virus (HSV) outbreak (n = 1). Only the HSV outbreak was considered to be related to combined treatments.
Although limited by relatively few subjects, the results of the present study suggest that the safety profile of MFU-V combined with other aesthetic products is consistent with the safety profiles of the individual treatments.
*Dermatology Cosmetic Laser Medical Associates of La Jolla, San Diego, California;
†Aesthetic Plastic Surgical Institute, Laguna Beach, California;
‡Premier Clinical Research, Spokane, Washington;
§Skin Associates of South Florida, Coral Gables, Florida;
‖Maryland Laser Skin and Vein Institute, Hunt Valley, Maryland;
¶Apothekon Inc., Woodbury, Minnesota
Address correspondence and reprint requests to: Sabrina G. Fabi, MD, Goldman, Butterwick, Fitzpatrick, Groff and Fabi Dermatology Cosmetic Laser, 9339 Genesee Avenue, Suite 300, San Diego, CA 92121, or e-mail: SFabi@gbkderm.com
This study was sponsored by Ulthera, Inc.; Mesa, AZ; and Merz GmbH, Frankfurt, Germany. S. G. Fabi is a consultant and researcher, Merz Pharmaceuticals. W. P. Werschler has served as a clinical investigator, consultant for Merz. M. P. Goldman performs research for Ulthera/Merz, Allergan, and Galderma. R. A. Weiss is a consultant and serves on the advisory board for Merz Pharmaceuticals.
The remaining authors have indicated no significant interest with commercial supporters.