Effectiveness and Safety of STYLAGE® L Lidocaïne in the Treatment of Nasolabial Folds
Condition: Aging
Study type: Interventional

Summary: 
      STYLAGE® L Lidocaine is a CE-marked hyaluronic acid gel intended to fill skin depressions on
      the face by dermal injection. In this study, 50 healthy subjects between the age of 30 and
      65, with moderate to severe nasolabial folds as assessed in live, who have given their
      informed consent and met all eligibility criteria, will be enrolled. Subjects will randomly
      receive injection of STYLAGE® L Lidocaine on one nasolabial fold and injection of an active
      comparator on the other nasolabial fold. A touch-up is possible if required one month after.
      Subjects will come to a total of 7 visits over a period of 12 months. Variation in severity
      score of nasolabial folds will be assessed in live and on photographs by independent
      evaluators. Variation in nasolabial fold depth, global aesthetic improvement, subject
      satisfaction, pain at injection site and safety will also be assessed.
    

Detailed description: 
      This is a prospective, multicenter, randomized, controlled versus active treatment,
      within-subjects study with blinded subjects and evaluators assessing the efficay and safety
      of STYLAGE® L Lidocaine in the treatment of nasolabial folds. Fifty healthy subjects between
      the age of 30 and 65, with moderate to severe nasolabial folds attaining either grade 3 on
      both sides or grade 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. Subjects will randomly receive dermal injections
      consisting in a maximum of 2 mL of STYLAGE® L Lidocaine on one nasolabial fold and a maximum
      of 2 mL of an active comparator on the other nasolabial fold. A touch-up consisting in the
      dermal injection of maximum 1 mL of product per nasolabial fold is possible if required one
      month after. Subjects will be followed up at 1, 3, 6, 9 and 12 months timepoints. Variation
      in severity score of nasolabial folds will be assessed in live and on photographs by
      independent blinded evaluators using the validated 5-point Wrinkles Severity Rating Scale
      (WSRS). Global aesthetic improvement will be assessed using the Global Aesthetic Improvement
      Scale (GAIS). Variation in nasolabial fold depth will be assessed using Dermatop®. Subject
      satisfaction, pain at injection site and safety will also be assessed.
    

Intervention name(s): STYLAGE® L Lidocaine; Active control
Intervention type(s): Device; Device
Intervention description(s): An injection of maximum 2 mL on one nasolabial fold is planned at Day 0. A touch-up of maximum 1 mL on the same nasolabial fold is possible 1 month after D0 (month 1).; An injection of maximum 2 mL on one nasolabial fold is planned at Day 0. A touch-up of maximum 1 mL on the same nasolabial fold is possible 1 month after D0 (month 1).
Other intervention name(s): Injection of hyaluronic acid gel; Injection of hyaluronic acid gel
Intervention MeSH terms: Lidocaine; Hyaluronic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Within-subject study with treatment of one nasolabial fold with the investigational medical device and treatment of the other nasolabial fold with a comparator (another medical device).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aging; Hyaluronic acid; Nasolabial fold; Injection; Healthy subjects; Independent evaluators; Prospective; Randomized study; Within-subject; Controlled; Multicenter