OBJECTIVES: To determine if there is any effect on tolerance, adverse events or clinical outcome when lidocaine is added to large gel particle hyaluronic acid (LGP-HA). MATERIALS AND METHODS: Single-centered, double-blinded, randomized, with-in patient trial, comparing patient comfort when receiving LGP-HA injections versus injections of LGP-HA mixed with lidocaine hydrochloride 2% (LGP-HA + L). Results were determined through patient questionnaires, standardized Canfield photography and blinded physician assessors. Participants were followed for six months. RESULTS:Eighteen females were enrolled and completed the study. The average pain rating was significantly less when LGP-HA + L was administered as reported by participants and blinded investigators. Average rating of bruising and redness were less with LGP-HA + L, but not significant. After six months, 100 percent of participants and 100 percent of the primary and secondary blinded investigators reported no difference in clinical outcome or longevity between the different treatments. There was no difference in adverse events. CONCLUSION: This is the first trial to report a six-month follow-up in a split-face study comparing LGP-HA + L to LGP-HA alone. All participant and investigator reports found symmetry of the NLFs at six months, thus demonstrating that the addition of lidocaine to LGP-HA does not affect longevity. Administration of LGP-HA + L is associated with less patient discomfort than administration of LGP-HA alone.
RCT Entities:
OBJECTIVES: To determine if there is any effect on tolerance, adverse events or clinical outcome when lidocaine is added to large gel particle hyaluronic acid (LGP-HA). MATERIALS AND METHODS: Single-centered, double-blinded, randomized, with-in patient trial, comparing patient comfort when receiving LGP-HA injections versus injections of LGP-HA mixed with lidocaine hydrochloride 2% (LGP-HA + L). Results were determined through patient questionnaires, standardized Canfield photography and blinded physician assessors. Participants were followed for six months. RESULTS: Eighteen females were enrolled and completed the study. The average pain rating was significantly less when LGP-HA + L was administered as reported by participants and blinded investigators. Average rating of bruising and redness were less with LGP-HA + L, but not significant. After six months, 100 percent of participants and 100 percent of the primary and secondary blinded investigators reported no difference in clinical outcome or longevity between the different treatments. There was no difference in adverse events. CONCLUSION: This is the first trial to report a six-month follow-up in a split-face study comparing LGP-HA + L to LGP-HA alone. All participant and investigator reports found symmetry of the NLFs at six months, thus demonstrating that the addition of lidocaine to LGP-HA does not affect longevity. Administration of LGP-HA + L is associated with less patient discomfort than administration of LGP-HA alone.