Restylane + Lidocaine and Restylane Lyft for the Treatment of Nasolabial Folds
Condition: Wrinkles Such as Nasolabial Folds
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to assess and compare the efficacy of two hyaluronic acid (HA) fillers
      on moderate, severe and extreme nasolabial folds (NLF).
    

Detailed description: 
      Background

      One of the most significant signs of aging is the appearance of deep lines that run from each
      side of the nose to the corners of the mouth [i.e., nasolabial folds (NLFs)]. These folds are
      defined by facial structures that support the buccal fat pad and separate the cheeks from the
      upper lip. The NLFs form due to volume shifts in the face, caused by a combination of fat
      descent and bone absorption, which results in sagging skin and hollowing.

      Soft tissue augmentation can effectively restore the youthful, harmonious contours of the
      face. The most popular non-invasive treatment options for volume loss in the face include the
      use of hyaluronic acid (HA) fillers. Injections of HA for skin rejuvenation are one of the
      most common aesthetic treatments performed worldwide. Due to their effectiveness, safety, low
      immunogenicity (HA is a normal component of human skin) and reversibility with hyaluronidase,
      HA fillers are understandably a popular option for facial volume restoration.

      Through recent advances in manufacturing technology, various types of HA fillers have been
      approved for the correction of facial wrinkles and folds, such as NLFs. Two such fillers, i)
      Restylane + Lidocaine and ii) Restylane Lyft, are well tolerated and provide significant
      improvement in this indication. These products contain the same amount of HA (i.e., 20mg/mL)
      and are manufactured using the same technology [i.e., non-animal stabilized hyaluronic acid
      (NASHATM)], but differ primarily in their particle size.

      Small particle size HA (Restylane + Lidocaine): was the first non-animal stabilized
      HA-containing filler approved for use in the United States. Because of its particle size
      (i.e., 330-430 μM), Restylane + Lidocaine is referred to as small gel-particle HA (SGP-HA).
      NASHA small gel contains approximately 100,000 gel particles per mL.

      Large particle size HA (Restylane Lyft): was approved in the United States in 2010 and is
      considered a large gel particle hyaluronic acid (LGP-HA). Restylane Lyft also contains the
      anesthetic lidocaine. NASHA large gel contains approximately 10,000 gel particles per mL.

      The difference in gel size between the two products results in different viscosity and
      lifting capabilities, which is anticipated to affect treatment outcomes. While the
      comparative research is limited, a small number of clinical trials have compared the two
      products. For example, two randomized studies performed using US populations have shown
      equivalent safety and similar efficacy of Restylane + Lidocaine and Restylane Lyft, in
      subjects of all Fitzpatrick skin types; and one recent study found that both products exhibit
      similar safety and efficacy in a Chinese population. These three comparative studies found no
      significant differences in safety of LGP- and SGP-HA however, efficacy changes can occur due
      to the injection techniques and depth of injection used by the investigators.

      This study is designed to assess and compare the efficacy of these two HA fillers on
      moderate, severe and extreme NLF, when using a modified technique. This modified technique
      will use a single puncture technique in each NLF, in comparison to others who have used a
      multi puncture, fanning or linear threading injection technique. For each NLF, a single bolus
      of product will be placed within the nasal pyriform aperture, on the periosteum. The location
      of the puncture will also vary from previous trials, in which injections were performed
      directly within the NLFs (to replace soft tissue volume). It is hypothesized that when these
      two products are used for replacing bone loss due to age-related resorption in the pyriform
      aperture, differences in efficacy will be observed that are not evident when they are used in
      soft tissue for volume augmentation. It is expected that while aesthetic outcomes and
      longevity of effect may be similar between the two products, the volumes required to achieve
      these same results will differ significantly, due to their different particle sizes.

      Study Rationale

      Larger HA gel particles result in better lifting capacities. Therefore, Restylane Lyft should
      display better efficacy in comparison to Restylane + Lidocaine when a "firm" product with a
      high lift capacity is required, such as when trying to replace or reshape bone. This is in
      contrast to replacing soft tissue volume, which was evaluated in earlier studies. However, as
      previous authors have reported, when these two products are used to replace soft tissue
      volume they both provide adequate lifting capabilities and thus result in similar efficacy
      levels.
    

Intervention name(s): Restylane + Lidocaine; Restylane® Lyft
Intervention type(s): Device; Device
Intervention description(s): Restylane + Lidocaine is a HA gel generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL with 0.3% lidocaine. It is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs.; Restylane® Lyft is a sterile gel of HA with lidocaine generated by Streptococcus species of bacteria, chemically cross-linked with BDDE (the cross linker), stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL. Lyft is intended to be used for facial tissue augmentation (Galderma Laboratories, 2014).
Intervention MeSH terms: Lidocaine; Hyaluronic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment