INTRODUCTION
Augmentation with hyaluronic acid (HA) dermal fillers is an increasingly popular aesthetic treatment approach to increase volume and improve the shape of the lips, as lips are associated with beauty and youth, and have an important role in facial aesthetic perception.1–3 This procedure is commonly requested by younger subjects, but an older population can also benefit from treatment as lips become thinner with age due to a decrease in collagen and elastin and thinning of the orbicularis oris muscle.4
The goal of lip augmentation is to create full, smooth, naturally contoured lips with the correct balance between the upper and lower lips and well-defined vermilion borders.5–7 It is also important to provide aesthetic improvement without hindering natural facial movement.8
Restylane Kysse (HARK), Restylane Refyne (HARR), and Restylane Defyne (HARD) are hyaluronic acid dermal fillers formulated with XpresHAn Technology™ (also known as Optimal Balance Technology (OBT) outside of the US), which is designed to achieve distributed tissue integration, and provide flexibility and support for maintaining natural movement in areas of dynamic expression.9–15 HARK is a product specifically designed for lip augmentation that was recently approved in the US in 2020 and has been approved in various countries outside of the US since 2010.9,16 HARR and HARD have been approved in the US since 2016 and were also used in the current study as add-on treatment for subjects who required lower face correction in addition to lip augmentation to achieve optimal results. HARR and HARD are FDA-approved for injection into the midâ€toâ€deep dermis for the correction of moderateâ€toâ€severe wrinkles and folds, such as NLFs and MLs. The softer gel structure of HARR is most appropriate for moderate wrinkles and folds while the firmer texture and larger gel calibration of HARD is suitable for correction of severe wrinkles and folds.10,11,17,18
In this open-label Phase IV post-marketing study, HARK was evaluated for aesthetic improvement and facial dynamics of
The goal of lip augmentation is to create full, smooth, naturally contoured lips with the correct balance between the upper and lower lips and well-defined vermilion borders.5–7 It is also important to provide aesthetic improvement without hindering natural facial movement.8
Restylane Kysse (HARK), Restylane Refyne (HARR), and Restylane Defyne (HARD) are hyaluronic acid dermal fillers formulated with XpresHAn Technology™ (also known as Optimal Balance Technology (OBT) outside of the US), which is designed to achieve distributed tissue integration, and provide flexibility and support for maintaining natural movement in areas of dynamic expression.9–15 HARK is a product specifically designed for lip augmentation that was recently approved in the US in 2020 and has been approved in various countries outside of the US since 2010.9,16 HARR and HARD have been approved in the US since 2016 and were also used in the current study as add-on treatment for subjects who required lower face correction in addition to lip augmentation to achieve optimal results. HARR and HARD are FDA-approved for injection into the midâ€toâ€deep dermis for the correction of moderateâ€toâ€severe wrinkles and folds, such as NLFs and MLs. The softer gel structure of HARR is most appropriate for moderate wrinkles and folds while the firmer texture and larger gel calibration of HARD is suitable for correction of severe wrinkles and folds.10,11,17,18
In this open-label Phase IV post-marketing study, HARK was evaluated for aesthetic improvement and facial dynamics of
