During screening, patients completed a questionnaire covering demographics, medical background and potential contraindications to therapy. Each patient signed an informed consent explaining the risks and benefits of the procedure. All 15 patients were female, eight of whom were under 40 years of age, and seven aged 40 years and over. The main inclusion criterion for the study was cellulite; exclusion criteria were contraindications to treatment, such as haemophilia, anticoagulants, thrombosis, tumour diseases, pregnancy, and cortisone therapy.

Each thigh was partitioned into three areas: front side, rear side and buttocks. The treatment was performed with the CERAma-x transmitter, applying a total of 24000 pulses at 2.6–4.6 bar and 18 Hz, depending on the pain intensity tolerated by the patient. Additionally, a massage was performed with the V-ACTOR, applying a total of 20000 pulses at 2.6–3.6 bar and 35 Hz. The patients were treated twice per week for 4 weeks, receiving a total of eight treatments.

The weight and circumference of both thighs were measured at screening (V), after the treatment period (ZW), and at the 4-week follow-up visit (FU). The degree of cellulite was determined by the aesthetic practitioner using the Cellulite Severity Scale (CSS) introduced by Hexsel7. CSS is a photonumeric cellulite severity scale with five criteria:

  • Number of evident depressions
  • Depth of depressions
  • Morphological appearance of skin surface alterations
  • Grade of laxity, flaccidity, or sagging skin
  • The classification scale originally described by Nürnberger and Müller.

Treatment progress was documented through a series of photographs covering all treated areas. For each patient one area at baseline, after the treatment period and at follow-up was selected, and four independent experts assessed the photographs according to a modified Hexsel scale. The modification was necessary, as point E of the Hexsel scale can only be assessed by palpation in direct contact with the patient. The scale ranges from 0 (no cellulite) to 12 points (maximum cellulite).

Figure 2

In addition, skin elasticity was measured at a defined spot within the treated area. The DermaScan® (Cortex Technology, Denmark) device is a 20 MHz ultrasound system delivering high resolution images with a height of 12.1 mm and a penetration depth of only a few millimetres (Figure 4). The velocity of sound was set to 1580 m/s, which is the generally accepted average velocity for skin tissue.

The settings for all measurements of all patients were constant in order to obtain comparable images. These images enabled the definition of a contour line at the skin surface and an additional line at the ‘rear side’ of the skin, possibly imaging the interface between the epidermis and the dermis.

Cellulite shows its characteristics in an irregularly formed interface8, resulting in a long contour line. By dividing the area between the two contour lines by the height of the image, it was possible to calculate a well-defined skin thickness.

Figure 3 Photographic documentation. (A) Patient 7KC is shown at the initial screening and (B) at the follow-up visit. The modified Hexsel Scale was reduced from the 8.2 average value to 5

Figure 3 Photographic documentation. (A) Patient 7KC is shown at the initial screening and (B) at the follow-up visit. The modified Hexsel Scale was reduced from the 8.2 average value to 5

The DermaLab® (Cortex Technology, Denmark) device is based on suction applied to the skin’s surface with a diameter of 1 cm. It measures the ‘negative’ pressure needed to suck the skin by 1.5 mm into the circular device. When the suction is shut off, the skin relaxes and the time required to retract to the original state is measured. With the known geometry of the sensor and the skin thickness measured with the ultrasound system, it is possible to calculate a parameter called Young’s Modulus (E), which is a measure of elasticity, equal to the ratio of the stress acting on a substance to the strain produced — in this case, the substance being the skin.