New Clinical Study Published in the Journal of Cosmetic Dermatology

A new peer-reviewed clinical study evaluating Sofwave’s synchronous parallel ultrasound technology for the treatment of cellulite has been published in the Journal of Cosmetic Dermatology (2025). The publication adds to the growing body of clinical literature examining non-invasive, energy-based approaches for improving the appearance of cellulite and skin laxity.

The study, titled “The Efficacy and Safety of Synchronous Parallel Ultrasound for the Clinical Improvement of Cellulite Using High-Density Handpiece,” reports outcomes from a prospective, multicenter U.S. clinical trial conducted across five investigational sites and evaluates treatment delivered using Sofwave’s LiftHD high-density handpiece.

The study was designed to assess both efficacy and safety of Sofwave’s synchronous parallel ultrasound technology under controlled clinical conditions. Sixty female participants between the ages of 23 and 65 were enrolled and treated on the thighs and/or buttocks. Each participant received two treatment sessions using the Sofwave system equipped with the LiftHD handpiece, with follow-up conducted three months after the second treatment.

Clinical outcomes were evaluated by three independent, blinded physicians using standardized and widely accepted assessment tools, including the Global Aesthetic Improvement Scale (GAIS), Cellulite Severity Scale (CSS), and Laxity Scale (LS). Standardized photography was used to support blinded image-based assessments, and participants also completed satisfaction questionnaires and rated treatment discomfort.

At the three-month follow-up, blinded physician assessments demonstrated visible improvement in 91% of treated areas based on GAIS evaluations. Quantitative analysis showed an average 69% improvement in Cellulite Severity Scale scores and a 53% improvement in skin laxity scores compared to baseline.

Patient-reported outcomes aligned with physician assessments, with 73% of participants indicating satisfaction with their results. Treatment-related discomfort was generally reported as mild to moderate, with a mean pain score of 4.26 out of 10. No serious or unanticipated adverse events were reported, and observed post-treatment effects were transient and resolved without intervention.

Cellulite is a common aesthetic concern with a wide range of existing treatment options, many of which involve invasive techniques or multiple treatment sessions. The findings from this study contribute peer-reviewed clinical data evaluating a non-invasive approach that addresses both cellulite appearance and skin laxity within a defined treatment and follow-up period.

According to the authors, Sofwave’s synchronous parallel ultrasound delivered via a high-density handpiece was associated with measurable clinical improvement and a favorable safety profile in the studied population. The study also highlights the role of independent, blinded evaluations in objectively assessing treatment outcomes in aesthetic medicine.The full open-access publication is available here: https://doi.org/10.1111/jocd.70597