Safety and Effectiveness of Juvéderm Ultra Plus Injectable Gel in Correcting Severe Nasolabial Folds in Chinese Subjects

Abstract

Background: Hyaluronic acid dermal fillers are effective in correcting severe nasolabial folds (NLFs) in non-Asian populations. We assessed safety and effectiveness of Juvéderm Ultra Plus in a Chinese population.

Methods: This double-blind study randomized Chinese subjects with severe NLFs to Juvéderm Ultra Plus (24 mg/mL) in 1 NLF and Restylane injectable gel (20 mg/mL) in the other NLF. NLFs were evaluated using the validated 5-point photonumeric Allergan NLF Severity Scale (0 is "no wrinkle" and 4 is "very deep wrinkle"). Investigator-assessed responder rates (primary outcome at 6 months), NLF mean improvements, and subject-assessed responder rates and preference were assessed.

Results: Of 124 subjects randomized, 122 completed the 6-month visit. NLFs treated with Juvéderm Ultra Plus required less volume than those treated with Restylane (median [range]: 0.80 [0.3-2.0] vs 1.00 [0.3-1.9]; P<0.001). Investigator-assessed responder rates were 90.4% for Juvéderm Ultra Plus and 89.6% for Restylane, establishing noninferiority of Juvéderm Ultra Plus. Mean (SD) improvements in NLF Severity Scale scores from baseline at 6 months were 1.5 (0.75) for Juvéderm Ultra Plus and 1.6 (0.73) for Restylane. Subject-assessed responder rates were similar to investigator-assessed rates (87.3%, Juvéderm Ultra Plus; 83.9%, Restylane). Of subjects reporting a preference, 62.1% preferred Juvéderm Ultra Plus. The most common treatment site responses were swelling and tenderness; most were mild or moderate in severity and resolved without intervention. Juvéderm Ultra Plus had fewer severe treatment site responses than Restylane.

Conclusion: In this study in Chinese subjects, Juvéderm Ultra Plus was safe and effective for correcting severe NLFs.

Fig. 1.

Subject disposition.

Fig. 2.

Five-point photonumeric Allergan Nasolabial Fold Severity Scale responder rates by visit as assessed by the evaluating investigator: intent-to-treat population.

Fig. 3.

Representative pre- and posttreatment photographs of subjects (A: 45 y old, 1-point improvement, each side; B: 44 y old, 2-point improvement, each side; C: 40 y old; 3-point improvement, Juvéderm Ultra Plus; 2-point improvement, Restylane) on the 5-point photonumeric Allergan Nasolabial Fold Severity Scale by evaluating investigator assessment.

Fig. 4.

Five-point photonumeric Allergan Nasolabial Fold Severity Scale responder rates by visit as assessed by subjects: intent-to-treat population.