| BODY SHAPING | ARTICLE
a mean value to be used for the study. Further standardisation of clinical measurements was obtained using a precise electro-optical proprietary system able to identify each volunteerÕs relevant anatomical landmarks on a grid panel. The anatomical landmarks reproducibility system (ALRS) used in this study comprised a vertical panel on which an electro-optical system regulates height markings; a fixed horizontal reference bar; two laser pointers mounted independently on two dedicated sliding gears, able to be positioned along the fixed horizontal bar; a grid panel, with a millimetric scale, positioned at a fixed distance from the measuring system to allow a correct plotting of spatial coordinates (Figure 2). Using the ALRS, clinical investigators were able to
perfectly identify all anatomical landmarks selected for the study. Their observations were concentrated at three different levels; waist, iliac spine, and gluteal crease. Once activated, each laser beam was directed to touch tangentially the outer silhouette of the body, generating a light projection on the grid panel, allowing a perfect identification of anatomical landmarks. A simple dermographic pen was then used to mark the measuring points on the skin. Ultrasound measurements (mm) were carried out at
each visit on the same anatomical regions. A BodyMetrix BX2000 (Genex S.r.l., Italy) 1–10 MHz sonographic system was used as an ultrasonic diagnostic source for this study6–10
Table 1 Circumference measurements and variations vs baseline values (data are expressed in cm)
T0 T2 T2–T0 T4 T4–T0 T8 T8–T0
Cosmeceutical active
formulation Placebo Waist Iliac spine Waist Iliac spine 86.2 85.2 -1.0* Sub-gluteus 98.8 97.8 -1.0* 85.1 85.0 -0.1 92.9 92.9 0 Sub-gluteus 98 98 0 84.1 94.3 93.5 - 0.8* 92.1
-2.1* 84.2 -2.0* -2.2*
96.9 -1.9* 85.1 0
92.8 -0.1 97.8 -0.2
. Standardised anatomical landmarks were
identified to allow a perfect comparison of subcutaneous fat measurements along the course of the study. A point located 3 cm laterally from the mid-vertical umbilical line was chosen for abdominal regions, and 3 cm cranially to iliac spine was selected for hip regions. Plicometry was used to further assess the thickness of
subcutaneous adipose tissue at hip level. A skinfold caliper (Gima S.p.A., Italy) with a standardised external compression of 10 g/mm2
was used for this task8 . All
measurements were taken under controlled environmental conditions (22±2 C, relative humidity < 60%). All study subjects were allowed to relax for 10–15 minutes for a perfect acclimatisation. All measurements were taken after a 10-hour minimum from the last topical application. Cosmetic acceptability of both study formulations
(active cream and placebo) was assessed by all volunteers at the end of the experimental trial. Efficacy and tolerability were assessed by volunteers and investigators at the same time interval.
Statistical analysis Statistical analysis was performed on a total number of 104 subjects as one volunteer, belonging to the placebo group, violated the study protocol showing a body weight increase of > 1.5 kg in 2 weeks. Two identical groups of 52 subjects were therefore evaluated. The Friedman test and Dunnett test were used to assess clinical data; ANOVA test and Dunnett test were performed to evaluate objective instrumental data. Wilcoxon test was used to compare clinical results induced by the two study formulations. StudentÕs t-test was performed to compare instrumental data.
Results No significant body weight variations were observed in both study groups during the whole duration of the study (Group 1, 52 subjects with active formulation; Group 2, 52 subjects with placebo cream). Morphometric evaluations confirmed a statistically significant slimming activity induced by the active formulation compared with placebo. Mean values of anatomical circumferences were found to be statistically reduced at T2 (after 2 weeks of continuous use) compared with baseline (DunnettÕs test P<0.05). A similar difference was confirmed at T8 (4 weeks after conclusion of topical applications). Relevant data are summarised in Table 1 and Figure 3. Placebo treated sites showed no statistically significant clinical and morphometric variations compared with baseline. Ultrasonographic measurements of subcutaneous
adipose tissue showed a statistically significant thickness reduction at T4 (DunnettÕs test P<0.05 vs T0). A 7.3% reduction was observed at abdominal level, and a 20% reduction at hip level. These data correspond with an average reduction of 1.71 mm at abdominal level, and 2.5 mm reduction at hip level. These observations were also confirmed through clinical assessment. The
Ô lipo-reducingÕ activity of the active formulation was quite statistically different to that of placebo treated sites at hip level at T4 (StudentÕs t-test P<0.05, T4 product vs T4 placebo). No significant modifications of clinical
CIRCUMFERENCES MEASUREMENT VARIATION vs BASELINE
0.0
-0.5 -1.0 -1.5
-2.0 -2.5 -3.0
92.6 -1.7* 97.2 -1.6*
85.1 0 92.7
-0.2 97.8 -0.2 * (Dunnet test P<0.05 vs T0)
-1.0
-0.8 -1.7 -2.1 -2.0 -1.9 -2.2 Waist
T2 – after 2 week treatment
Iliac spine
T4 – after 4 week treatment
Subgluteus
T8 – 4 weeks after the end of the treatment
Figure 3 Circumference measurements of anatomical areas treated with tested active cosmeceutical formulation. Variations are plotted against baseline values
prime-journal.com | July/August 2012 ❚ 21
-1.0 -1.6
Variation vs TO – mean value (cm)
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