Safety of the Immediate Reconstitution of Poly‐l‐Lactic Acid for Facial and Body Treatment—A Multicenter Retrospective Study

• Published in: Journal of cosmetic dermatology 2024-09, Vol.23 (12), p.3918-3923
• Main Authors: Vasconcelos‐Berg, Roberta, Real, Julia, Wenz, Franziska, Avelar, Luiz Eduardo Toledo
• Format: Article
• Language: English
• Subjects: Adult; Aged; biostimulator; Cellulose; Cicatrix - etiology; Cosmetic Techniques - adverse effects; Dermal Fillers - administration & dosage; Dermal Fillers - adverse effects; dilution; Face; Female; filler; Humans; immediate reconstitution; Injectable; Injections, Subcutaneous - adverse effects; Lactic Acid; Male; Mannitol; Middle Aged; Original; PLLA‐SCA; Polyesters - administration & dosage; Polyesters - adverse effects; poly‐l‐lactic acid; reconstitution; Retrospective Studies; safety; Skin Aging - drug effects
• ISSN: 1473-2130; 1473-2165; 1473-2165
• DOI: 10.1111/jocd.16560

ABSTRACT Background Poly‐l‐lactic acid (PLLA‐SCA; Sculptra) was approved in 1999 in Europe and 2004 in United States as a collagen biostimulator. It is a freeze‐dried preparation containing 150 mg PLLA‐SCA per vial and, since approval, has been recommended to be reconstituted 72 h before treatment, which can hinder its use in clinical practice. In 2021, the manufacturer authorized the reconstitution of PLLA‐SCA immediately before use. Objective To evaluate adverse events in patients treated with immediately reconstituted PLLA‐SCA on the face, body, and scars. Method This was a retrospective analysis of medical records of patients treated with immediately reconstituted PLLA‐SCA for aesthetic purposes from January 1, 2021, to December 31, 2021, at two medical centers. Results A total of 274 treatment sessions were conducted on 167 patients (ranging from 1 to 5 sessions per patient). Of these, 228 sessions (151 patients) targeted the face, 39 sessions (22 patients) addressed the body, and 7 sessions (5 patients) focused on scars. The mean final concentration of PLLA‐SCA was 15.30 mg/mL for the face, 8.35 mg/mL for the body, and 10.53 mg/mL for scars. The majority of injections were administered with a blunt cannula (face: 87.3%, body: 100%, scars: 57%), and in 6 out of 7 scar treatments, PLLA‐SCA was additionally applied topically after fractional treatment. One patient developed a PLLA‐SCA nodule 30 days after facial treatment, which resolved after two saline injections. The most common adverse events were bruising (face: 6.57%, body: 7.69%) and mild pain (face: 3.07%). No events required further intervention. Conclusion This study reports an adverse event profile with immediately reconstituted PLLA‐SCA, used on the face, body, and scars, similar to that reported with PLLA‐SCA reconstituted 72 h prior to use. Trial Registration This was a retrospective study of medical records at two medical centers, and trial registration was not required.