EVALUATION OF ANTI-CELLULITE EFFICACY 311 These data suggest an effi caceous activity on the smoothness parameter provided by the formulation vehicle (Tables III–VI). In the upper third of the thigh the reduction provided by the product ACTIVE was 14% with regard to visual appearance and 21% with regard to appearance at pinching (statisti- cally signifi cant vs placebo), with at least one degree of improvement in the visual scores (Figure 2), while in the median/lower third of the thigh the reduction was found to be 23% for visual appearance and 13% for appearance at pinching (statistically signifi cant vs placebo), with at least one degree of improvement in the clinical scores. As far as the other cellulite-related symptoms are concerned, the following clinical results were observed: A statistically signifi cant improvement ( • p0.05 vs baseline) in the fi rmness of the inner thigh in the upper third (at least one degree of improvement). A statistically signifi cant reduction ( • p0.05 vs baseline) in the pain at pinching, both in the upper third (-82%) and, to even a greater extent, in the median/lower third (-100%) of the thigh (Figure 3). On the other hand, no signifi cant variation was observed in the placebo-treated areas. Table II Statistical Analysis—Comparison of ACTIVE vs Placebo Clinical evaluations of thigh—median/lower third Wilcoxon test Time p-value Signifi cance Visual appearance T0 NA - T4 0.0268* p0.05 Appearance at pinching T0 0.1667 NS T4 0.0151* p0.05 Firmness T0 NA — T4 0.08 NS Smoothness T0 NA — T4 0.3388 NS Pain at pinching T0 NA — T4 0.088 NS Table III Statistical Analysis—Comparison of Placebo T0 to T4 Clinical evaluations of thigh—upper third Wilcoxon test T0 T4 p-value Signifi cance Visual appearance 1.87 ± 0.757 1.87 ± 0.757 1.0000 NS Appearance at pinching 2.43 ± 0.507 2.39 ± 0.499 0.7769 NS Firmness 1.87 ± 0.757 2.00 ± 0.798 0.0880 NS Smoothness 2.30 ± 0.926 3.48 ± 0.790 0.0001 p0.001 (**) Pain at pinching 0.22 ± 0.518 0.13 ± 0.344 0.1667 NS
JOURNAL OF COSMETIC SCIENCE 312 As far as skin smoothness is concerned, the highly signifi cant and clinically important improvement observed at the end of the trial on the whole thigh was similar for both tested products, active and placebo, suggesting a smoothing activity promoted by the vehicle. Instrumental evaluations confi rmed the effi cacy of the active formulation in counteract- ing the signs and symptoms of cellulite: Contact thermography • . The tested product induced a signifi cant (p0.01 vs baseline) reduction of 17% in the mean score of the thermographic stage of “cellulite.” The result proved to be close to statistical signifi cance in comparison to the placebo (p=0.0564). Table IV Statistical Analysis—Comparison of Placebo T0 to T4 Clinical evaluations of thigh—median/lower third Wilcoxon test T0 T4 p-value Signifi cance Visual appearance 1.30 ± 1.020 1.22 ± 1.085 0.1667 NS Appearance at pinching 2.04 ± 0.767 1.96 ± 0.825 0.1667 NS Firmness 2.30 ± 0.703 2.30 ± 0.703 1.0000 NS Smoothness 2.30 ± 0.926 3.48 ± 0.790 0.0001 p0.001 (**) Pain at pinching 0.17 ± 0.388 0.13 ± 0.344 0.3388 NS Table V Statistical Analysis—Comparison of ACTIVE T0 to T4 Clinical evaluations of thigh—upper third Wilcoxon test Time p-value Signifi cance Visual appearance T0-T4 0.0151 p0.05 Appearance at pinching T0-T4 0.0109 p0.05 Firmness T0-T4 0.0086 p0.05 Smoothness T0-T4 0.0001 p0.001 (**) Pain at pinching T0-T4 0.0481 p0.05 Table VI Statistical Analysis—Comparison of ACTIVE T0 to T4 Clinical evaluations of thigh—median/lower third Wilcoxon test Time p-value Signifi cance Visual appearance T0-T4 0.0086 p0.05 Appearance at pinching T0-T4 0.0151 p0.05 Firmness T0-T4 0.0880 p0.05 Smoothness T0-T4 0.0001 p0.001 (**) Pain at pinching T0-T4 0.0481 p0.05
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