Study Objective: To evaluate Juvéderm Vollure™ XC, a hyaluronic acid (HA) gel (17.5 mg/mL) based on the Vycross ® technology platform, for long-term correction of moderate to severe nasolabial folds (NLFs).Design: This was a prospective, randomized, within-subject-controlled study.Method: Subjects (N=123) received Vollure XC initial/touch-up treatment in 1 NLF and control HA filler in the contralateral NLF. Effectiveness endpoints for Vollure XC included NLF Severity Scale (NLFSS) responder rates (≥1-point improvement vs baseline) through Month 18 after initial/touch-up treatment and at 1 month after optional repeat treatment. Additional effectiveness endpoints included subject-assessed Appraisal of Nasolabial Folds (FACE-Q; 0-100 scale) through Month 18 after initial/touch-up treatment and subject satisfaction on an 11-point scale (0=completely dissatisfied; 10=completely satisfied) through Month 18 after initial/touch-up treatment and at 1 month after repeat treatment. Injection site responses (ISRs) were assessed.
Results:After initial/touchup treatment, Vollure XC responder rates were 93% at Months 1, 3, and 6, 85% at Month 9, decreased to 59% at Month 18, and increased to 94% at 1 month after repeat treatment. Improvement in mean FACE-Q scores over 18 months versus baseline showed continued benefit of Vollure XC from the subject perspective; at Months 3, 6, 12, and 18, FACE-Q scores were 70, 73, 58, and 50, respectively, versus baseline score of 32. Subjects reported a high level of satisfaction with Vollure XC throughout the study, with 82% of subjects very satisfied with treatment at Month 6, 76% at Month 12, 68% at Month 18, and 94% at 1 month after repeat treatment. Common ISRs during initial treatment with Vollure XC were firmness (89%), swelling (86%), and tenderness to touch (84%). Most ISRs were mild or moderate in severity.
Conclusion:Treatment with Vollure XC was safe and effective for correcting moderate to severe NLFs, with results lasting through 18 months in over 50% of subjects.