Efficacy and safety assessment
pain
ADVERSE REACTIONS
The primary outcome of the study was the clinical improvement of the NLFs. The improvements were graded using a 5-point scale: 2 = “much improved,” 1 = “improved,” 0 = “no change,” − 1 = “worsened,” and − 2 = “much worsened.” Two blinded dermatologists subjectively evaluated photographs at the 1-, 3-, 6-, and 12-month follow-ups. All clinical photographs were taken with identical camera settings, lighting, and positioning using a Canon PowerShot G9 standoff camera (OMNIA Imaging System, Canfield Scientific, Inc., Fairfield, NJ, USA).In addition, the NLF facial volumes were objectively evaluated using three-dimensional photographs captured by a Vectra H1 Imaging System (Canfield Scientific Inc.) immediately after injection and at the 1-, 3-, 6-, and 12-month follow-ups. Patients also performed self-assessments using the same 5-point scale at each follow-up visit. In addition, the patient pain experienced while the injections were being administered was rated using a 10-point visual analog scale (VAS). Any adverse reactions were recorded.Statistical analyses were performed using PASW Statistics for Windows, version 18.0 (SPSS Inc., Chicago, IL, USA). Descriptive analysis was used for demographic data. Nasolabial folds volume changes were calculated using repeated measures ANOVA and paired t-test. Subjective improvement evaluation was analyzed by using Wilcoxon signed-ranks test. A probability (The Ethics Committee of the Siriraj Institutional Review Board approved this study (approval number si690/2014). The study was performed per the Helsinki Declaration of 1964 and subsequent amendments. Written informed consent was obtained from all patients before their enrollment.