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ARTICLE | BODY SHAPING | parameters were registered after further analysis of the


two study groups at T8. Subcutaneous fat thickness reduction in the active formulation treated group reached -7.5% on abdominal sites ® corresponding to an average decrease of 1.76 mm compared to baseline ; and -9.7% at hip level ® corresponding to an average decrease of 1.21 mm. These data confirmed the long-lasting biological activity of active cream compared with placebo (Table 2 and Figure 4). Hip plicometry in the active formulation treated group


showed a statistically significant reduction of subcutaneous fat at T2 (DunnettÕs test P<0.05 T2 vs T0), with a mean decrease in thickness of 1.24 mm ® corresponding to a percentage of -6.5% compared with baseline. A further decrease was observed at T4, reaching -10.8% ® corresponding to a mean reduction of 2.08 mm. These data were statistically different from the placebo treated group (StudentÕs t-test P<0.05, T4 product vs T4 placebo). The lipo-reducing activity of the active formulation was maintained 4 weeks after the cessation of topical applications (DunnettÕs test P<0.05, T8 vs T0; StudentÕs t-test P<0.05, T8 product vs T8 placebo) (Table 3 and Figure 5).


Clinical assessment Clinical assessment of subcutaneous fat at hip and abdominal levels was performed using the following five-grade visual classification scale: ■ 0 = smooth skin with no visible localised adipose tissue accumulations


■ 1 = slightly visible localised adipose tissue accumulations (light grade)


■ 2 = moderately evident localised adipose tissue accumulations (light-to-moderate grade)


■ 3 = undoubtedly evident localised adipose tissue accumulations (moderate grade)


■ 4 = severely evident localised adipose tissue accumulations (severe grade). The active formulation was able to induce a statistically


evident visual improvement to the hip regions at the end of the full treatment period (T4) compared with baseline (Figure 6). Clinical evaluation scores improved, by at least one grade, in 56% of treated subjects (DunnettÕs test P<0.05, T4 vs T0). Clinical evaluation scores were still clinically consistent ® a one-grade improvement compared with baseline ® in 46% of treated subjects at T8 (4 weeks after last product application) (Wilcoxon test P<0.001, T4 product vs T4 placebo; Wilcoxon test P<0.01, T8 product vs T8 placebo) (Table 4, Figures 7 and 8).


Subjective assessment Analysis of the questionnaires completed by study subjects confirmed a subjective visual improvement in 50% of volunteers on active formulation treated sites. Volunteers were asked to evaluate the clinical efficacy of topical formulations on a five-level improvement scale: 1 = no improvement; 2 = minimal improvement; 3 = moderate improvement; 4 = marked improvement; 5 = very marked improvement. Abdominal regions were perceived as improved by 50% of study subjects (37%


22 ❚ July/August 2012 | prime-journal.com


Table 2 Ultrasonographic measurements and variations vs baseline values


T0 T2 T2–T0 T4 T4–T0 T8 T8–T0


Cosmeceutical active


formulation


Abdomen 23.38 22.64 -3.2% 21.67 -7.3% 21.62 -7.5% (3 cm sideward


-0.74mm


umbilicus) Hips


(iliac spine) Placebo


umbilicus) Hips


Abdomen (3 cm sideward


(iliac spine) -1.71mm* -1.76mm*


12.46 11.20 -10.1% 9.96 -20% 11.25 -9.7% -1.25 mm*


-2.49mm*,** -1.21mm* 24.07 24.53 +0.46mm 11.28 11.53 +0.25mm 11.90 +0.62mm 24.46 +0.39mm 11.89 +0.61mm * (Dunnet test P<0.05 vs T0, ** Student t-test P<0.05 T4 product vs T4 placebo)


moderate improvement, 13% marked improvement). Hip regions were perceived improved by 51% of subjects (35% moderate, 12% marked, and 4% very marked). A total of 42% of the active formulation treated group observed a circumference reduction at waist level (29% moderate and 13% marked); 70% confirmed a clinical perception of improved skin smoothness (35% moderate, 33% marked, and 2% very marked); and 60% found their skin tone significantly improved (33% moderate, 21% marked, and 6% very marked). Analysis of completed questionnaires obtained from the placebo-treated group confirmed a significant perceived improvement in skin smoothness reported by 63% of subjects (33% moderate, 26% marked, and 4% very marked). No significant slimming activity was reported by the placebo treatment group. These data were comparable with the clinical efficacy perceived by investigators at T4 and T8. No adverse events directly related and/or unrelated to


study formulations were observed for the duration of the study. Volunteers rated the tolerability of both formulations as good-to-excellent (100%) at the end of treatment period. A four-level grading scale was used to assess perceived intrinsic cosmeceutical properties of study formulations: 1 = poor; 2 = sufficient; 3 = good; 4 = excellent.


ULTRASONOGRAPHIC ASSESSMENT VARIATION % vs BASELINE


3% -1%


-2%


-5% -9%


-10%


Figure 4 Ultrasonographic assessment of anatomical


areas treated by tested active cosmeceutical formulation. Variation (%) are plotted against baseline values


-13% -17% -21% -25%


-13% -18% -21% -24% Waist


T1 – after 1 week treatment


Hip


T2 – after 2 week treatment


Thighs


T4 – 4 weeks treatment


-11% -1% -1% 23.99 -0.08mm


Variation vs TO (%)


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