Effectiveness and Safety of STYLAGE® M LIDOCAINE Versus STYLAGE® M in Filling Nasolabial Folds
Condition: Aging
Study type: Interventional

Summary: 
      This clinical investigation is designed to compare the STYLAGE® M Lidocaïne to STYLAGE® M in
      terms of correction of nasolabial folds severity and pain felt by the subject, and to assess
      and compare the safety and effectiveness of both products.

      Subjects with moderate to severe nasolabial folds will receive both treatments in a
      split-face design at D0, and a touch-up will be done 14 days after if necessary. The subjects
      will be followed-up over a 12-month period after initial injection.
    

Detailed description: 
      The study will be prospective, triple-blinded (Subject, Treating Investigator, and Blinded
      Live Evaluator),randomized,within-subjects (split-face),active-controlled, monocenter with
      blinded subjects and evaluators assessing the efficacy , safety and pain of STYLAGE® M
      Lidocaïne and STYLAGE® M in the treatment of nasolabial folds.

      Sixty five healthy subjects between the age of 30 and 65, with symetrical moderate to severe
      nasolabial folds with grade 3 or 4 on both sides on the Wrinkle Severity Rating Scale (WSRS)
      for nasolabial folds as assessed in live, who have given their informed consent and met all
      eligibility criteria, will be enrolled.

      STYLAGE® M Lidocaïne will be injected in one nasolabial fold (right or left according to the
      randomization list). STYLAGE® M will be injected in the contralateral nasolabial fold.

      A touch-up is possible if required 14 days after. Subjects will be followed up at 14 days, 3,
      6 and 12 months timepoints. All the effectiveness and safety evaluations will be done by a
      Blinded Live Evaluator (BLE) who will be different from the Treating Investigators.

      Variation in severity score of nasolabial folds will be assessed in live by the BLE and
      retrospectively assessed on photographs (2D) by an Independent Photographic Reviewer using
      the validated 5-point Wrinkles Severity Rating Scale (WSRS) at each time point The subjects
      and the independent blinded evaluator will assess the overall aesthetic improvement level of
      the face, for each side independently, at each time point after treatment initiation The
      subjects will be asked to score the pain felt during injection, and 5, 15 and 30 minutes
      after injection on a Visual Analog Scale .
    

Intervention name(s): STYLAGE® M Lidocaïne; STYLAGE® M
Intervention type(s): Device; Device
Intervention description(s): Up to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 14 days after on the same nasolabial fold (touch-up).; Up to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 14 days after on the same nasolabial fold (touch-up).
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Within-subject study with treatment of one nasolabial fold with STYLAGE® M and STYLAGE® M Lidocaïne of the other nasolabial fold
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hyaluronic acid; Nasolabial Folds; Injection; Healthy subjects; Prospective; Randomized; Pain; Within-subjects