| PaTienT exPerience | arTIcle


contributing to the follow-up investigation was: day 0 = 71 patients; day 14 = 56 patients; day 30 = 61 patients; day 90 = 45 patients; day 135 = 36 patients; day 180 = 34 patients; and day 240 = 22 patients. a touch-up treatment was performed for 42 patients (75%) at day 14 and 10 patients (16%) at day 30.


Wrinkle severity assessment The initial average wrinkle severity as judged by investigators was 2.17. immediately after the injection the average wrinkle severity was reduced to 1.28 and to 1.16 1 month after the injection. The average score remained between 1.16 and 1.52 in the first 6 months and reached 1.7 after 240 days (Figure 1). The evaluation of the wrinkle severity score shows a significant immediate improvement of the wrinkles, as well as a long-lasting effect of the filler (Figure 2).


Patients satisfaction assessment The majority of patients assessed the outcome of the treatment at each point of time as ‘reached expectations’ or ‘Some improvements’ (Figure 3). On day 240, 72% of patients indicated that their expectations about the treatment were reached; 16% noticed ‘Some improvement’, and only 11% experienced ‘no effect’ (Figure 4).


Safety all the side-effects were closely associated with treatment or touch-up injections, and included redness (73%), swelling (34%), pain (26%), and haematoma (20%) (Figure 5). nodules, which have been reported in 1.6% of patients in the immediate post-injection period, are likely related to subcutaneous accumulation of the product, as all had disappeared when these patients attended the subsequent follow-up visit. in 13% of cases no immediate


80%


30% 40% 50% 60% 70%


20% 0%


10% 11% 16%72%


No effectSome improvement


Reached expectations no adverse events were reported in


the long term after the initial treatment. These results highlight the relative high safety profile of the Princess filler.


0% Hyper


correction Figure 4 Patient


satisfaction distribution at the last follow-up visit (240 days) (1 = no effect; 2 = some improvement;


3 = reached expectations; 4 = overcorrection)


prime-journal.com | November/December 2011 ❚ 47


2.8 2.7 2.6 2.5 2.4 2.3 2.2 2.1


Immediately after


14 days 30 days 90 days 135 days


180 days


240 days


Figure 3 Self-assessment of the correction results by patients during the follow-up period (1=no effect; 2=some improvement; 3=reached expectations; 4=overcorrection)


adverse effects were reported at all. redness systematically occurs at injection points as it is a trauma linked to the introduction of the needle. Swelling is also a common secondary effect, as well as haematoma. Pain is a feeling commonly associated with injections. no adverse events were reported in the long term after the initial treatment. These results highlight the relative high safety profile of the Princess Filler.


Discussion notwithstanding the relatively high drop in the rate of patients during the follow-up period, the study displays a satisfactory efficacy of the product with a significant reduction in wrinkle severity score, with sustained results at the end of the follow-up period. Patient satisfaction levels remained high at the end of follow-up period. The observed adverse events correspond to ‘injection


site reactions’ commonly associated with the application of dermal fillers. This includes swelling, redness,


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