ARTICLE | BODY SHAPING |


Figure 2 Clinical images taken pre- and post-cosmeceutical treatment. (A) (T0)


pre-treatment, (B) (T4) after


4 weeks of treatment. The red laser spot observed on both pictures originates from the instrumentation used to


standardise clinical evaluations Exclusion criteria for the study were:


■ Smoking habit ■ Daily alcohol consumption ■ Low-calorie diet with the aim to lose weight ■ Recent changes (1 month) to normal daily habits ■ Body weight variation beyond ±1.5 kg within 1 month prior to the start of the study


■ Weight-loss or weight-control drugs ■ Recent (1 month) application of topical skin treatments (cosmeceutical, pharmacological, mechanical, energy-assisted) to the skin test areas


■ Drugs interfering with the bodyÕs metabolic functions and those generally responsible for body weight variations


■ Skin allergy to test cream components or dermatologic conditions altering normal skin barrier function on tested areas


■ Recent (6 months) or current hormonal treatments, dermatological diseases, endocrine disorders, hepatic disorders, cardiac disorders, pulmonary diseases, neurological or psychological disorders. The study protocol


The last visit was planned to assess a possible


long-term persistence of results. The treatment protocol consisted of twice-daily topical applications of a standardised volume of cream (1 fingertip unit per 10 cm2


)


on selected anatomical areas, followed by a light massage until full absorption was obtained. The volunteers involved in the test had been previously informed and trained by the investigator on the correct use of the cream and the exact amount to be used. All study subjects agreed not to modify their eating habits and personal lifestyles for the duration of the study. The active formulation and placebo cream were


Fixed anatomical landmarks


were identified to properly standardise circumference measurements: transumbilical


horizontal line, anterior iliac spine, and subgluteal furrow.


Circumference measurements were taken three times on each anatomical region, calculating a mean value to be used for the study.


included a body weight check on all study subjects at each scheduled visit (allowed variation in body weight range ±1.5 kg). Four visits were scheduled to monitor clinical results:


■ Baseline (T0) = before topical applications ■ Intermediate (T2) = 2 weeks after the beginning of treatment


■ Final (T4) = after completing the full 4 weeks of treatment


20 ❚


■ Long term (T8) = 4 weeks after completion of treatment.


July/August 2012 | prime-journal.com


blindly distributed between two equal groups of 55 subjects. Five subjects (three from the active formulation group, and two from the placebo group) did not complete the study because of problems unrelated to the use of the tested products. Study populations were therefore 52 subjects for the active formulation arm, and 53 subjects for the placebo formulation arm, bringing the total number of study subjects to 105. The efficacy of the tested products was assessed at each


visit using clinical observation and instrumental evaluations. Clinical observation included a visual evaluation of the treated sites according to a five-grade localised adiposities severity scale; and a standardised circumference measurement of the waist, hips, and subgluteal region. Fixed anatomical landmarks were identified to


properly standardise circumference measurements: transumbilical horizontal line, anterior iliac spine, and subgluteal furrow. Circumference measurements were taken three times on each anatomical region, calculating


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