Table 2.
Study characteristics of RCTs and cohort studies only included in adverse effect analysis.
| Study | Study design | n * | Female ratio | Age: mean ± SD (median) (range) | Intervention | Control | Statistics | Follow-up (weeks) | Outcome |
|---|---|---|---|---|---|---|---|---|---|
| Artzi et al. (53) | Cohort, multicenter, retrospective | 3† | 90% | 49.6, (28–70) | Juvéderm Volbella (Allergan) | No control group | Spearman correlation | 96 | Immediate and delayed AEs |
| Carruthers et al. (54) | Cohort, single center, open label | 15 | 100% | (40.50), (33–60) | Restylane | No control group | Descriptive statistics | 24 | SP, AEs |
| Carruthers et al. (52) | Randomized, parallel-group, multicentre, clinical trial | 23 | 100% | 48.4 ± 5.5 | Juvéderm Ultra, Juvéderm Ultra Plus | OnabotulinumtoxinA, OnabotulinumtoxinA plus hyaluronic acid | Kruskal-Wallis test, Wilcoxon rank sum test | 24 | GAIS, CIS, AEs |
| Downie et al. (51) | Randomized, parallel-group, double blinded, single-center, clinical trial | 23 | 100% | (25–55) | Perlane | Various collagen fillers | Kruskal Wallis Rank Sum test | 48 | 2D and 3D facial image analysis, AEs |
| Fischer et al. (55) | Cohort, multicenter, retrospective | 146 | 98.6% | 44.7 ± 14.6 | CPM-HAL1 and CPM-HAL2 (Belotero Balance Lidocaine) | No control group | Descriptive statistics | 16 | Merz scale, GAIS, VAS, AEs |
| Philipp-Dormston et al. (56) | Cohort, multicenter, open label, prospective | 60 | 88.7% | 39.7 (21–75) | Juvéderm Volbella | No control group | Descriptive statistics | 4 | 4-grade scale for subject and injector satisfaction, AEs |
| Rzany et al. (57) | Cohort, multicenter, open label, prospective | 76 | 94.8% | 54.5 ± 8.2 | Emervel | No control group | Descriptive statistics | 24 | GAIS: LRS, LFGS, satisfaction questionnaires, AEs |
| Samuelson et al. (58) | Cohort, multicenter, evaluator blinded, prospective | 29 | 100% | 36, (19–59) | Restylane Lip Volume | Baseline-controlled | Proportion with 95% CI | 36 | GAIS, MLFS, AEs |
*
Number of participants included in the MA analysis (Exclusion due to study groups using different filling material or other anatomical sites.
†
Study population number is 400 (mean age: 49.6, range: 28–70), however only 3 patients received lip augmentation with HA filler.
AEs, Adverse events; CIS, Cosmetic Improvement Scale; GAIS, Global Aesthetic Improvement Scale; ISRs, Injection site responses; LFGS, Lip Fullness Grading Scale; LRS, Lemperle Rating Scale; MLFS, Medicis Lip Fullnes Scale; RCT, Randomized controlled trial; SP, Standardized photography; VAS, Visual Analog Scale.