Juvéderm Ultra for Lip Enhancement: An Open-Label, Multicenter Study

Abstract

Juvéderm Ultra injectable gel (Allergan, Inc, Irvine, California) is approved in the United States to treat moderate to severe wrinkles and folds, such as nasolabial folds. It is also used to enhance the appearance of the lips. The authors evaluated the safety and effectiveness of Juvéderm Ultra injectable gel for lip enhancement and assessed the utility of 3 new lip-specific effectiveness scales. In this multicenter study, 50 subjects received lip enhancement with Juvéderm Ultra injectable gel. The subjects were observed closely by the treating investigator and results were evaluated by a blinded independent rater and by subject self-assessment for up to 48 weeks to determine the durability of the effects. A validated lip fullness scale (LFS) was used for analysis. Treatment satisfaction was assessed by investigators and subjects using an 11-point scale. At week 12, 71% of subjects had achieved their goals for lip fullness and had maintained improvement of at least 1 grade on the LFS, which greatly exceeded the a priori criterion of 40% for success. At week 24, improvement in lip fullness was still present for 56% of subjects. Satisfaction and goal achievement exceeded 90% for subjects as well as investigators. Common side effects were predominantly mild or moderate in intensity and resolved within 1 week in the majority of subjects. Juvéderm Ultra injectable gel is safe and effective for lip enhancement. Scales for assessing lip fullness provide an objective method to determine the effectiveness of treatment.