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. 2021 Aug 6;8:681028. doi: 10.3389/fsurg.2021.681028

Table 1.

Study characteristics of records included in effectiveness analysis.

References Study design n * Female
ratio
Age: mean ± SD (median) (range) Intervention Control Maximum injected volume; injection technique Follow-up (months) Outcome measure
Beer et al. (41) RCT, multicentre, evaluator blinded 199 97% 45.5 Restylane-L No-treatment group 2.17 ml (mean); anterograde, retrograde linear threading, serial puncture 6 MLFS and WASULL, GAIS, TEAEs
Chopra et al. (46) Cohort, multicentre, open label, prospective 57 93% 46.5, (23–72) Restylane-L Baseline-controlled 1–3 ml (range); submucosa, retrograde, anterograde linear, fanning 3 GAIS, MLFS, TEAEs
Dayan et al. (42) RCT, multicentre, evaluator blinded 208 95.8% (49), (20–79) Juvéderm Ultra XC (HYC-24L) No-treatment group 4.8 ml (max); linear threading, serial puncture, fanning, crosshatching 12 ALFS, POL, OCS, ISRs, AEs
Eccleston et al. (47) Cohort, multicentre, open label, prospective 59 100% 50, (21–74) Juvéderm Volbella Baseline-controlled 1.3 ml (median); retrograde, tunneling, crosshatching 12 ALFS, AEs
Fagien et al. (48) Cohort, multicentre, evaluator blinded, prospective 50 96% (47), (24–68) Juvéderm Ultra Baseline-controlled 2.2 ml (median), 2.3 ml (max); retrograde, anterograde, tunneling, serial puncture 12 ALFS, OCS, POL, CTR, AEs
Geronemus, et al. (43) RCT, multicentre, evaluator blinded 224 96.9% (54), (22–78) Juvéderm Volbella XC (VYC-15L) Restylane-L 2.5 ml (median); subdermal, intradermal, tunneling, puncture 12 ALFS, POLSS, POLM, OCS, GAIS, AEs
Glogau et al. (44) RCT multicentre, evaluator blinded 135 99% 47.6 ± 10.6, (50.0), (18.0–65.0) Restylane No-treatment group 1.5 ml (max), 0.3–2.5 ml (range); linear injection technique, serial puncture 6 MLFS, GAIS, AEs
Raspaldo et al. (45) RCT multicentre, evaluator blinded 268 97.1% (48), (18–76) Juvéderm Volbella (with Lidocaine) Restylane-L 1.97–1.86 ml (mean); intradermal, subdermal, tunneling 12 ALFS, POL, OCS, AEs, ISRs,
Solish and Swift (49) Cohort, multicentre, evaluator blinded, prospective 18 86% 41.1 ± 11.4, (40), (26–65) Restylane Baseline-controlled 1.5 ml (max); anterograde, vertical, deposition formation 3 MLFS, GAIS, AEs
Yazdanparast et al. (50) Cohort, single center, open label, prospective 10 100% (28–45) Hyamax Kiss Baseline-controlled 1 ml (max); retrograde 6 MLFS, IGA, VAS, AEs
*

Number of participants included in the MA analysis (Exclusion due to study groups using different filling material or other anatomical sites.).

AEs, Adverse events; ALFS, Allergan Lip Fullness Scale; CTR, common treatment-site responses; GAIS, Global Aesthetic Improvement Scale; IGA, Investigator's Global Assessment; ISRs, Injection site responses; MLFS, Medicis Lip Fullness Scale; OCS, Oral Commissure Severity Scale; POL/POLSS, Allegran Perioral Severity Scale; POLM, Allergan Perioral Lines at Maximal Contraction scale; SP, Standardized photography; TEAE, treatment-emergent adverse events; VAS, Visual Analog Scale; WASULL, Wrinkle Assessment Scale of Upper Lip Lines.