The Efficacy of Massage in Reducing Nodule Formation After Poly-L-Lactic Acid Administration for Facial Volume Loss: A Randomized, Evaluator-Blinded Clinical Trial

摘要

BACKGROUNDThe risk of nodule formation following poly-l-lactic acid (PLLA) injections for facial volume loss is well known. Traditionally, post-treatment massage according to the 5-5-5 rule (5 times per day for 5 minutes for 5 days) has been applied to mitigate this risk. However, such a regimen may be onerous for patient compliance. Using currently accepted injection technique and product dilution, the efficacy of massage for nodule prevention has never been formally evaluated.OBJECTIVETo evaluate the efficacy of massage in reducing the incidence of nodule formation post-PLLA injection.MATERIALS AND METHODSAfter obtaining informed consent, 20 subjects with facial lipoatrophy were enrolled in this randomized, evaluator-blinded clinical trial. Each subject was treated with 1 vial of PLLA each month for 3 months. Vials were diluted with 1 mL of 1% lidocaine and 7 ml of bacteriostatic water, shaken with a vortex and refrigerated for 24 to 48 hours before injection. Ten subjects were instructed to massage the treated areas according to the 5-5-5 rule and 10 subjects did not perform any massage post-treatment. Six-month follow-up data were collected for treatment efficacy and adverse events.RESULTSNo nodules were reported by subjects or detected by the blinded evaluator regardless of massage status. Significant improvements in facial lipoatrophy were detected 1, 3, and 6 months after the final treatment session and were not statistically different between the 2 groups.CONCLUSIONUsing currently recommended guidelines for product preparation and injection, the application of massage post-PLLA facial treatment does not have a significant impact on nodule formation or treatment efficacy.