Duration of wrinkle correction following repeat treatment with Juvéderm hyaluronic acid fillers

Abstract

Many patients elect to have repeat treatments with hyaluronic acid dermal fillers to maintain wrinkle correction, but the clinical performance of these products after repeat treatments has not been formally assessed. The primary objective of this study was to evaluate the effectiveness of Juvéderm injectable gel (Juvéderm Ultra, Juvéderm Ultra Plus, and Juvéderm 30) through 1 year after repeat treatment of nasolabial folds (NLFs) that were previously treated with Juvéderm or Zyplast 6-9 months prior to the repeat treatment. Upon completion of the pivotal IDE clinical trial for Juvéderm, five of the original 11 study sites were selected to participate in an extended follow-up evaluation, and a total of 80 subjects were enrolled. For the Juvéderm-treated NLFs in each treatment group, the median injection volume was 1.5-1.6 mL for initial treatment but only 0.5-0.6 mL for the repeat treatment (p < 0.0001). Mean Investigator-assigned NLF severity scores on a scale of 0-4 for the Juvéderm-treated NLFs improved from 2.5-2.7 (moderate to severe) at baseline to 1.2-1.5 (mild) just prior to repeat treatment (>24 weeks) and 0.7-0.9 (mild) at 4 weeks after repeat treatment. At 48 weeks post-repeat treatment, the mean NLF scores were 1.1-1.3 (mild), and 78-90% of subjects were considered responders (≥1 point improvement). Thus, subjects sustained a total of 18-21 months of wrinkle correction with a repeat treatment at 6-9 months and needed substantially less filler (60% less) for repeat treatment than for initial treatment, indicating that retreatment at this timepoint may be beneficial to patients.

Figures

Fig. 1

Subject disposition flowchart. aPlanned enrollment was 150 subjects. The primary reason that 150 was not achieved was that subjects were ineligible because they chose to delay repeat treatment beyond the window allowed in the Juvéderm follow-up study protocol. bThe primary reason for subjects not re-enrolling in the extended portion of the Juvéderm follow-up study was that they had already passed the 6-month timepoint when the protocol amendment was implemented

Fig. 2

Median injection volume at initial and repeat treatment

Fig. 3

Mean NLF severity score assessed by Investigators

Fig. 4

Mean improvement from baseline in NLF severity score based on Investigator assessments

Fig. 5

Percent of subjects with improved NLF severity scores from initial baseline based on Investigator assessment

Fig. 6

Subjects demonstrating duration of effect with Ultra, Ultra Plus, and J30 dermal fillers at baseline and 24 and 48 weeks after repeat treatment