Vol. 5, n. 3, September-December 2009 - Salute per tutti

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A. Sparavigna Table 1. Profilometry: nasolabial folds variation percentage vs baseline. –40% ** –13% T1 (1 month after the 1 st intradermal implant) R a (roughness average parameter) –38% ° / * T2 (2 months after the 1 st intradermal implant) GROUP I (with food supplement) GROUP II (without food supplement) –28% –21% * * –9% * p
Clinical evaluation of a nutraceutical containing lycopene, soy isophlavones and vitamin C on the performance and duration of an intradermal filler Table 2. Tolerance: dermatological signs. SUBJECTS (%) GROUP I T-1 T0 T1 T2 T6 (intradermal implants (baseline) (before the 1 st (before the 2 nd (2 months after the 1 st (6 months after the 1 st and food supplementation) intradermal implant) intradermal implant) intradermal implant) intradermal implant) Erythema 61% 39% 39% 0% 46% Oedema 0% 0% 0% 0% 0% SUBJECTS (%) GROUP II T-1 T0 T1 T2 T6 (intradermal implants) (baseline) (before the 1 st (before the 2 nd (2 months after the 1 st (6 months after the 1 st intradermal implant) intradermal implant) intradermal implant) intradermal implant) Erythema 85% 69% 54% 23% 54% Oedema 0% 0% 0% 0% 0% T1, T2 and T6 a clinically and statistically significant reduction (Dunnett test p < 0.05 vs T0) of R a and R t parameters, that represent the mean roughness and the maximum wrinkle height (the absolute value between the highest and lowest peaks of a given profile). The reduction percentages of above mentioned parameters versus baseline (T-1) resulted more marked when compared to the ones obtained for the Group II; in particular in Table 1 are summarised, for each study time, the variation percentages of all measured profilometric parameters versus baseline (T-1) and the achived statistical significance in comparison to the Group II (Student t test). Obtained results show clearly as the food supplement intake increased the activity of filler product on nasolabial folds which appeared after the 1 st intradermal implant and also after the 2 nd significantly (Student t test) less deep and marked when compared to the Group II; at T6 this result is still present and clinically considerable, although no statistically significant difference versus control group was found. Volunteer’s efficacy judgment 69% of volunteers included in the Group I appreciated the efficacy of intradermal implants associated to the food supplementation on deep wrinkles (8% as very marked, 38% as marked and 23% as medium) and superficial wrinkles (46% as marked and 23% as medium). These p e rcentages are comparable to the ones obtained for the Group II. A more consistent percentage of subjects noted the antiage activity of the food supplement on skin tonicity (69%-15% as very marked, 31% as marked and 23% as medium), skin smoothness (78%-39% as marked and 39% as medium) and skin brightness (85%-8% as very marked, 46% as marked and 31% as medium), that resulted at the end of the trial visibly improved. Tolerance evaluation Dermatological assessment In Table 2 the percentages of subjects that presented subjective signs and symptoms as slight erythema, oedema are summarised. For both groups no statistically or clinically significant variation, as well as no worsening of basal conditions was noticed. Adverse events No adverse event related to the study products (injectable product or food supplement) occurred during the entire study period. For subjects n. 8 of Group I and n. 8, 11 and 13 of Group II the medical assessment performed at T2 and at T6 highlighted the presence of some intradermal little nudules imputable to a temporary thickening of the injectable product at level of the treated area. This is an expected effect dependent to a slower reabsorption of the filler and it is not considered an adverse event. C onclusions Clinical and instrumental evaluations confirmed the antiage activity of “Innèov Re-Age Fermeté” and demonstrated as the food supple- Journal of Plastic Dermatology 2009; 5, 3 245
Page 1 and 2: ISSN 2035-0686 Vol. 5, n. 3, Septem
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