Post marketing study of safety and efficacy of Crystalys, a calcium hydroxyapatite based filler for facial soft tissue augmentation
Tsvi Segal, MD; Ana Schwartz, MD; Konstantin Konfino, MD, PhD
Objective: In this post marketing study our primary objective was to assess the safety of Crystalys, a new calcium hydroxyapatite based filler, in subjects who received sub-dermal or deep-dermal injections for facial soft tissue augmentation. The secondary objective was to evaluate the performance of Crystalys within six months of injection.
Methods: Crystalys was injected to 173 patients, age ranging from 27–72 years, with a variety of facial aesthetic conditions, most common being pronounced nasolabial folds. On average, patients were injected with 3.4 ml of Crystalys. After obtaining informed consent form, the subjects were evaluated for adverse events (AEs) and efficacy using three different performance methods.
In this post marketing study, high safety and performance level of Crystalys for facial soft tissue augmentation was observed. The study was administered to 173 patients with varying facial deficiencies and results were evaluated using different performance methods.
Results: Safety – 173 patients were evaluated for adverse events. No severe, serious or longlasting AEs were reported or recorded by patients or physicians. In addition, all events were selfresolving. All reported AEs are common when treated with all injectable fillers. The AEs reported were: Ecchymosis, Edema, Erythema and Pain. Efficacy – efficacy ratings were performed on a subset of 59 patients using the Lemperle Rating Scale (LRS) and the Global Aesthetic Improvement Scale (GAIS) validated clinical scales. In addition, a 5-point Likert scale User Satisfaction Questionnaire was filled out by 72 patients. Crystalys dermal implant demonstrated excellent efficacy results, using both the LRS and GAIS scales, and by user satisfaction ratings. All scales indicated an overall improvement in treated facial areas, coupled with markedly high patient satisfaction scores.