Table 5.
Published Efficacy/Safety Data and Protocols on PLLA in Hands
| Reference (Nb of Patients) | Design/Objectives | Efficacy | Safety | Reconstitution/Vial | Treatment Sessions | Injection Technique/Device | Nb Vial | |||
|---|---|---|---|---|---|---|---|---|---|---|
| Volume/Time | Total Volume | Nb | Intervals (wks) | Per Session | Total | |||||
| Redaelli 2006133 (N=27) | Clinical practice Volume loss F-U: 6–15 months |
DGS: 4 to 9 | Nodule formation (n=1) | 5 mL (session 1) or 6–8 mL for 12 h + C3% | 5.5– 9 mL |
3–6 | 4 (session 1–3)/12 | Linear threading SC injection Needle 25–27G |
1 | 3–6 |
| Sadick et al 2008131 (N=26) | Clinical practice Volume loss |
High level of patients’ satisfaction | Bruising, swelling, pain, itching; no nodule formation | 5–6 mL o/night + L1% | 8– 10 mL |
1–3 | 4–8 | Linear threading injection into the immediate subdermal plane Needle 25G 1.5-in |
1 | 3 |
| Fabi and Goldman 2012;132 Palm et al 201069 (N=8) | Clinical practice Volume loss |
Patients’ satisfaction: 63% of patients with good to excellent results | Nodule formation (n=1) | 5 mL o/night + L1% | 12 mL | 2–3 | 4 | Fanning injection in the SC tissue plane Needle 27G 1.5-in |
1 | 2–3 |
| Vleggaar 200667 (NR) | 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 to o/night + L2% | 5 mL | NR | 4–6 | Tunneling injection in the deep dermal subcutaneous plane Device NR |
NR | NR |
Abbreviations: AE, adverse events; C, carbocain; DGS, Definitive Graduated Score (from 1–10 with 10 associated with the best results); L, lidocaine; NR, not reported; SC, subcutaneous.