arTIcle | PaTienT exPerience | Background
The Princess® family of dermal fillers was introduced to the european market in 2008. Princess fillers are developed using a unique technology called SMarT (Supreme Monophasic and reticulated Technology), which allows for the creation of a highly dense tridimensional matrix, while guaranteeing the highest degree of safety. Based on biofermentative hyaluronic acid, Princess
hyaluronic acid is a natural substance and a
significant component of the extracellular matrix, where it plays a vital
role in water homeostasis and wound healing.
fillers are cross-linked using butanediol diglycidyl ether (BDDe). as BDDe is known to be toxic agent, particular attention is paid to the purification process. in order to ensure that toxin-free BDDe is completely removed, a specified dialysis step is performed after the cross-linking procedure. in addition, every batch of the final product undergoes gas chromatography to test the BDDe content. The limit of BDDe residuals in the finished product is ≤ 2 ppm, which is one of the lowest in the dermal fillers on the market. This threshold is further confirmed through the use of biocompatibility testing in vivo. The Princess Filler is indicated
for the correction of moderate to severe wrinkles. it is also indicated for perioral wrinkles, lip contour and lip volume increase. it is recommended that the filler is injected into the mid to deep dermis to achieve a very natural look and long-lasting correction.
Materials and methods Subjects This non-interventional open-label 8-month study was performed from november 2008 (first patient entered) until november 2009 (last patient completed) at seven centres across austria, israel and Poland. The study was conducted (injections and assessment) by experienced injectors from austria, Poland and israel. The patients were selected by each physician from his/her own practice according to the inclusion and exclusion criteria. Pregnant women and subjects who had undergone major surgery (including dental extractions and recent dermal implantation) within the last 6 months, those with allergies, herpes, acne, dermal diseases, diabetes, systemic diseases, or taking non-steroidal anti-inflammatory drugs (nSaiDS), antibiotics, anticoagulants or cortisone, were excluded from the study. all patients provided written informed consent before entering the study. The same inclusion/ exclusion criteria and regulatory requirements were used in all countries.
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Treatment Patients were allowed to choose from a selected list of areas with which to receive treatment using the Princess Filler, including the glabella, nasolabial folds, and marionette lines (off-label indications). The use of topical anaesthetics was allowed. as the injection
November/December 2011 |
prime-journal.com
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