Table 1.
Published Efficacy/Safety Data and Protocols on PLLA in Neck and Chest
| Reference (Nb of Patients) | Design/Objectives | Efficacy | Safety | Reconstitution/Vial | Session/Patient | Injection Technique/Device | Nb Vial** | |||
|---|---|---|---|---|---|---|---|---|---|---|
| Volume/Time | Total Volume | Nb | Intervals (wks) | Per Session | Total | |||||
| Fabi 201566 Vanaman & Fabi 201550 (NR) | Clinical practice Wrinkles and lines |
Visual improvement (PA) | Common minor reaction disappearing rapidly: Pain, ecchymoses, edema, pruritus, hematoma, nodule | 7 mL* for 2–24h + L1% | 16 mL | 3–4 | 4 | Linear threading injection into the reticular dermis and subcutaneous tissue Needle/cannula 25G 1.5-inch |
1 | 3–4 |
| Zac & Da Costa 202062 (NR) | Technical publication Wrinkles and lines |
NR | Transient hematomas, ecchymoses | 8 mL for 24–48h + L2% | 20 mL | 1–4 | 4–8 | Injection between the deep dermis and subcutaneous tissue Needle 26G |
1 (12/20 mL) | 1–4 |
| Mazzuco & Hexsel, 200961 (N=36) | Clinical experience Skin laxity, atrophy and wrinkles F-U: 18 months |
81–100% GAIS improvement (n=21) Patients’ satisfaction: 91.6% (n=36) Effect maintained up to 18 months |
Transient hematomas, ecchymosis; early-onset subcutaneous nodule (n=1) | 10 mL for 48–72h + L2% | 11.9 mL | 1–4 | 4–6 | Injection between the deep dermis and the subcutaneous tissue Needle 27 G |
1 (4–7 mL) | 1–4 |
| Bolton et al 201163 (N=28) | Clinical practice, Retrospective study review Chest wrinkles scale F-U: 18 months |
1- to 2-point FBWS improvement Effect maintained up to 18 months |
No AE reported during the study period, no nodule formation | 14 mL* for > 2h-o/night + L1% | 16 mL | 1–7 | 4 | Needle 26G 1.5-in | 1 (16 mL) | 1–7 |
| Wilkerson & Golberg 201864 (N=25) | Prospective review Moderate-to severe crepiness and chest wrinkles F-U: 6 months |
90% of patients with ≥1-point FBWS improvement 6-month post treatment | No AE reported by investigators | 9 mL, incubation time NR | 9 mL | 3 | 8–12 | Intradermally injection Needle 27G |
1 | 3 |
| Peterson & Goldman 201152 (NR) | Clinical practice, retrospective review Chest rhytids |
Skin quality improvement (PA) | Ecchymoses, edema, pain, pruritus, inflammation, nodules, hematomas | 6 mL for 24h + L1% | 16 mL | 3–4 | 4 | Retrograde fanning injection in the subcutaneous tissue Needle 27G 1.5-in |
1 | 3–4 |
| Lorenc, 201222 (NR) | Clinical practice Volume loss |
Effective volume restoration (PA); High patient satisfaction (96%) | Safe | 5 mL > 2h + L1% | 24 mL | 1–2 | 6 | Tunneling injection in the supraperiostal plane Needle 27G 0.5-in |
NR | NR |
| Vleggaar, 200667 (N=64/2131) | Clinical practice Skin laxity F-U: 4–6 weeks post-treatment |
95.1% of patient satisfied | No serious AE; ecchymosis, transient soreness | 4 mL, 30 min - o/night + L2% | 5 mL | NR | 4–6 | Tunneling injection in the deep dermal subcutaneous plane Device NR |
NR | NR |
| Redaelli & Forte, 200968 (N=234/568) | Clinical practice Sin laxity F-U: 12 months |
DGS improvement of 7.5 to 7.8 | Few temporary AE, nodule formation (1%) | 6–8 mL 24–48h | 6–8 mL | NR | NR | Linear retrograde injection in the deep dermis/subcutis layer Needle 25–27G |
NR | NR |
Note: *Reconstitution in bacteriostatic water instead of sterile water for injection; **Volume injected when reported.
Abbreviations: AE, adverse event; DGS, definitive graduated score; FBWS, Fabi-Bolton 5-point wrinkle scale; GAIS, Global Aesthetic Improvement Scale with Grade 1, very much improved, Grade 2, much improved, Grade 3, improved, Grade 4, no change, Grade 5, worse; F-U, follow-up; L, lidocaine; NR, not reported; PA, photographic assessment.