Effectiveness and Safety of STYLAGE® M Lidocaïne for Lips' Volume Augmentation and/or Redefinition of the Outline of the Lips (SMILE) — SMILE  

Esthetics Clinical Trial

Official title: SMILE Study: Effectiveness and Safety of STYLAGE® M Lidocaïne for Lips' Volume Augmentation and/or Redefinition of the Outline of the Lips

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Esthetics

• NCT number: NCT04813614
• Study type: Interventional
• Source: Laboratoires Vivacy
• Status: Completed
• Phase: N/A
• Start date: May 31, 2021
• Completion date: July 12, 2022