Abstract
BACKGROUND: Cellulite is a common aesthetic condition of the skin, predominantly affecting more than 90% of postpubertal females. Energy-based devices (EBDs) have demonstrated efficacy in treating a variety of dermatologic concerns. A controlled thermal injury to the dermis can stimulate remodeling of the extracellular matrix (ECM), leading to skin tightening, an effect that may improve the dimpled appearance of cellulite. OBJECTIVE: To assess the efficacy and safety of synchronous parallel ultrasound using a high-density handpiece for improving cellulite appearance. MATERIALS AND METHODS: Sixty subjects, aged 23-65, were enrolled in a prospective, open-label, non-randomized, multicenter study. Subjects underwent two treatment sessions using a novel ultrasonic system equipped with a new high-density handpiece, applied on either one side or both sides of the thighs and/or buttocks. The follow-up period extended up to 3 months after the second treatment. Clinical improvements were evaluated by three blinded physicians based on baseline and follow-up photographs, using the Cellulite Severity Scale (CSS), Global Aesthetic Improvement Scale (GAIS), and Laxity Scale (LS). Satisfaction questionnaires were completed by subjects. Treatment discomfort was rated immediately after treatment using the Numerical Scale Response (NSR). RESULTS: Sixty subjects, with a mean age of 47, were enrolled in the study. GAIS results showed improvement in 91% of the treated areas, CSS score improved by 69%, while LS score improved by 53%. Most subjects (73%) reported satisfaction. Mean pain score was 4.26 ± 2.33. No serious adverse events were reported. CONCLUSION: The novel ultrasound system was found to be effective and safe for improving cellulite appearance.