Effectiveness and Safety of STYLAGE® M Lidocaïne for Lips' Volume Augmentation and/or Redefinition of the Outline of the Lips (SMILE)
Condition: Esthetics
Study type: Interventional

Summary: 
      STYLAGE® M Lidocaine is a hyaluronic acid injectable gel CE (conformité européenne)-marketed
      since 2009 . It is indicated for the outline of the lips and/or for lips augmentation in lips
      mucosa. It is also indicated to fill skin depressions on the face. Lidocaine is intended to
      reduce the pain associated with the injection.

      The aim of SMILE study is to demonstrate that STYLAGE® M Lidocaine is non-inferior to an
      active comparator that has shown its effectiveness in lips' volume augmentation and
      restoration in improving the aesthetic appearance of the lips evaluated by subjects.

      In this study, 92 healthy volunteers between 18 and 65 years old, who expressed the wish for
      augmentation or restoration of the volume of the lips and/or lips' outline redefinition,
      confirmed by investigators at inclusion, who have given his/her informed consent and who met
      all the eligibility criteria, will be enrolled.

      Subjects will randomly receive STYLAGE® M Lidocaïne or the active comparator (ratio 1:1)
      injection in the lips at first visit on Day 0. At second visit, one month after Day 0, an
      optional touch-up injection could be performed according to subject's and investigator's
      opinions and if the subject is still eligible.

      Subjects will have a total of 6 visits over a 12 months follow-up period and a screening
      visit prior to first injection.

      Proportion of subjects having a global aesthetic improvement of their lips (blinded
      self-evaluation), 3 months after treatment initiation will be assessed and compared between
      the two groups. This will also be done during the other visits (1, 6, 9 and 12 months after
      treatment initiation). Global aesthetic improvement according to blinded independent
      evaluator, subjects' satisfaction, pain during injection and safety parameters will also be
      assessed during the study period.
    

Detailed description: 
      This is a prospective, double blinded, randomized, active controlled, multicenter study.
      Subjects are randomly assigned to receive either STYLAGE® M Lidocaine or the active
      comparator (ratio 1:1).

      Ninety two subjects between 18 and 65 years old who expressed the wish for augmentation or
      restoration of the volume of the lips and/or lips' outline redefinition, confirmed by
      investigators at inclusion, who have given his/her informed consent and who met all the
      eligibility criteria (especially according to the instructions for use of the devices), will
      be include.

      After a screening visit for selection, each subject will be followed for 12 months after 1st
      injection at Visit 1 (on Day 0). Five follow-up visits are scheduled 1, 3, 6, 9 and 12 months
      after initial injection (Visits 2 to 6). At 1 month (Visit 2), an optional touch-up injection
      may be done (if needed).

      The primary objective is to demonstrate non-inferiority of STYLAGE® M Lidocaine versus the
      active comparator in improving the aesthetic appearance of the lips. The comparison of
      effectiveness between the devices will be done according to proportion of subjects having an
      improvement on the 5-point Global Aesthetic Improvement Scale (GAIS) evaluated by the blinded
      subject on the lips (after mirror self-examination), 3 months after treatment initiation
      (V1). Improvement according to GAIS corresponds to one of these three categories: "Very much
      improved", "Much improved" or "Improved".

      Secondary objectives include subjects' self-evaluation of their lips according to GAIS, at 1,
      6, 9 and 12 months after treatment initiation. Global aesthetic improvement of the lips
      according to blinded independent evaluator, subjects' satisfaction, subjects' self-evaluation
      of pain during injection will also be measured and collected at each visit during the whole
      study period. Study products tolerance will be assessed by collection of injection site
      reactions after each injection session, and adverse events throughout the study.
    

Intervention name(s): STYLAGE M Lidocaine; Active control group
Intervention type(s): Device; Device
Intervention description(s): Injection in the lips; Injection in the lips
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, double blinded, randomized, active controlled, multicenter study (post-market clinical follow-up).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hyaluronic acid; lips; volume; outline