Placebo controlled, prospectively randomized, double-blinded study for the investigation of the effectiveness and safety of the acoustic wave therapy (AWT^®) for cellulite treatment

Abstract

Placebo controlled double-blinded, prospectively randomized clinical trial with 17 patients (11 verum, 5 placebo) for evaluation of cellulite treatment with Acoustic Wave Therapy, (AWT^®) was performed.

The patients were treated once a week for 7 weeks, a total of 8 treatments with the D-ACTOR^® 200 by Storz Medical AG. Data were collected at baseline, before 8th treatment, at 1 month (follow-up 1) and at 3 months (follow-up 2) after the last treatment with a patients’ questionnaire, weight control, measurement of circumference and standardized photography. Treatment progress was further documented using a specially designed 3D imaging system (SkinSCAN^3D, 3D-Shape GmbH) providing an objective measure of cellulite (primary efficacy criteria).

Patient's questionnaire in the verum group revealed an improvement in number and depth of dimples, skin firmness and texture, in shape and in reduction of circumference. The overall result (of skin waviness, Sq and Sz, surface and volume of depressions and elevations, Vvv and Vmp) at two follow-up visits indicates a more than medium sized superiority (MW = 0.6706) and is statistically significant (p_Wei–Lachin = 0.0106). The placebo group revealed no statistical significance. No side effects were seen. This indicates the efficacy and safety of AWT^® for patients with cellulite.

Key Words::

• acoustic wave therapy
• adipose tissue
• cellulite
• extracorporeal pulse activation technology
• extracorporeal shock wave treatment
• 3D skin measurements

Declaration of interest: The authors report no declarations of interest. The authors alone are responsible for the content and writing of the paper.

The authors Gerd Haller, Dr Pavel Novak, Alexander Krotz are employees of Storz Medical AG. Johannes C. Vester and Dr Katharina Russe-Wilfingseder have been supported by Storz Medical AG.