Cellulite and extracorporeal Shockwave therapy (CelluShock-2009) - a Randomized Trial

<p>Abstract</p> <p>Background</p> <p>Cellulite is a widespread problem involving females' buttocks and thighs based on the female specific anatomy. Given the higher number of fat cells stored in female fatty tissue in contrast to males, and the aging process of connective tissue leads to an imbalance between lipogenesis and lipolysis with subsequent large fat cells bulging the skin. In addition, microcirculatory changes have been suggested, however remain largely unknown in a controlled clinical setting. We hypothesize that the combination of extracorporeal shockwave and a daily gluteal muscle strength program is superior to the gluteal muscle strength program alone in cellulite.</p> <p>Methods/Design</p> <p>Study design: Randomized-controlled trial. IRB approval was granted at Hannover Medical School, Germany on May 22, 2009. For allocation of participants, a 1:1 ratio randomization was performed using opaque envelopes for the concealment of allocation. Reporting: according to CONSORT 2010. Eligible patients were females aged 18 or over and 65 or younger with cellulite with documented cellulite 1°-4° according to the Nürnberger score. Exclusion criteria were suspected or evident pregnancy, no cellulite, no informed consent or age under 18 years or above 65 years. Patients were recruited by advertisements in local regional newspapers and via the Internet. Analysis: Intention-to-treat. Outcome parameters: a) Photonumeric severity scale, b) Nürnberger Score, c) circumference measurements, d) capillary blood flow, e) tissue oxygen saturation, f) postcapillary venous blood flow. Intervention group: Six sessions of extracorporeal focused shock wave for six sessions (2000 impulses, 0,25 mJ/m2 every 1-2 weeks) at both gluteal and thigh regions plus a specific gluteal strength exercise training. Control group: Six sessions of sham extracorporeal focused shock wave for six sessions (2000 impulses, 0,01 mJ/m2 every 1-2 weeks) at both gluteal and thigh regions plus a specific gluteal strength exercise training. Follow-up: 12 weeks. Blinding was achieved for all participants enrolled in the trial, the photograph taking the digital images for the primary outcome measure, the two assessors of the outcome measures, all additional health care providers and for the analyst from the biometrical department. Only one researcher (BJ) was aware of the group assignment performing the randomisation and the extracorporeal shock wave therapy.</p> <p>Discussion</p> <p>This randomised-controlled trial will provide much needed evidence on the clinical effectiveness of focused extracorporal shock wave therapy as an adjunct to gluteal strength training in females suffering cellulite.</p> <p>ClinicalTrials.gov identifier</p> <p>NCT00947414</p

Stage‐related PD‐L1 expression in Kaposi sarcoma tumor microenvironment

Background The immune checkpoint molecule PD‐L1 represents an important target in oncological immune therapy. The aim of our study was to evaluate PD‐L1 expression and the composition of the tumor microenvironment (TME) in Kaposi sarcoma. Methods Immunohistochemical stains were performed for PD‐L1, CD3, CD33, CD68, and CD168 in 24 Kaposi sarcoma samples. In PD‐L1‐positive cases, the double stains for PD‐L1, CD31, podoplanin, and HHV8 were added. Results PD‐L1 was observed in 71% of the samples and was predominantly located in the TME. PD‐L1 expression was significantly higher in nodular stage than in patch/plaque stage. The TME consisted of CD68+/CD163+ macrophages, CD33+ myloid‐derived suppressor cells and monocytes and CD3+ T‐cells. The TME showed a peritumoral distribution in nodular stage, in contrast to a diffuse distribution in patch/plaque stage. In 12 samples (50%), no plasma cells were found. Conclusion In nodular stage of KS, the TME is pushed back in the periphery of the tumor nodules. The PD‐L1‐positive TME between the tumor cells might protect them from the immune attack. An anti‐PD‐L1 treatment might be promising in KS patients