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arTIcle | PaTienT exPerience |


2.5 2


1.5 1


0.5 0


Before Immediately after


14 days 30 days safety assessments were


performed at day 0, day 14 and day 30, after the injections. Potential side‑effects that were noted included redness, bruising, swelling, itching, nodules and pain.


techniques are multiple, and the assumption is that


the experienced injector is able to select the right technique for each indication, no specific instructions with regard to technique were given. investigators applied the filler according to their usual practice using the technique of their choice. The injection volume was also selected at the discretion of the investigator to reach a full correction. The exact injection volume was documented. The range of the volume of Princess Filler injected per side in each area treated was between 0.15 ml to 0.9 ml.


90 days 135 days


180 days


240 days


Figure 1 Wrinkle severity assessment score by investigators during follow up period of 240 days (1=complete correction to fin; 2=moderate; 3=deep to severe; 4=extreme)


The investigators were allowed to perform a single


touch-up treatment after 14 or 30 days, if full correction of the wrinkle was not achieved according to the investigator’s or a patient’s opinion.


Data collection The severity of folds and wrinkling was assessed by the investigators on a four-point wrinkle assessment scale (WaS), the points of which were defined as: ■ 1 = mild wrinkle ■ 2 = moderate wrinkle ■ 3 = severe wrinkle ■ 4 = extreme wrinkle. Wrinkle assessments were carried out immediately


before and after treatment (baseline, day 0), and on days 14, 30, 90, 135, 180, and 240. Patients’ and investigators’ degrees of satisfaction were assessed using a four-point scale:


■ 1 = no effect ■ 2 = some improvement ■ 3 = reached expectations ■ 4 = overcorrection. Patients were followed for 240 days after the first


injection. The degree of satisfaction was scored at every visit: day 1, day 14 (touch-up possible), day 30 (touch-up possible), day 90, day 135, day 180 and day 240. Safety assessments were performed at day 0, day 14


and day 30 after the injections. Potential side-effects that were noted included redness, bruising, swelling, itching, nodules and pain.


Figure 2 A patient (A) before, (B) immediately after, (C) 30 days after, and (D) 240 days following the injection of 1 ml of Princess Filler in the nasolabial folds


Results Subjects a total of 71 patients were recruited and treated, with a ratio of 7% male and 93% female. The mean age was 51 years (range 25–70 years). The number of subjects


46





November/December 2011 | prime-journal.com


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