Effectiveness and Safety of IPN-20-SENSE LIDOCAINE for Lip Volume Augmentation and/or Redefinition (SMILE Study): A Non-inferiority Randomized Double-Blinded Controlled Study

• Published in: Aesthetic plastic surgery Vol. 49; no. 4; pp. 1033 - 1045
• Main Authors: Froget, Nicolas, Kobylińska, Izabela, Warszawik-Hendzel, Olga, Guidicelli, Thomas, Gotlib, Julia
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.02.2025; Springer Nature B.V
• Subjects: Adult; Anesthetics, Local - administration & dosage; Cosmetic Techniques; Dermal fillers; Dermal Fillers - administration & dosage; Dermal Fillers - adverse effects; Double-Blind Method; Esthetics; Female; Humans; Hyaluronic acid; Hyaluronic Acid - administration & dosage; Hypotheses; Intervention; Lidocaine - administration & dosage; Lidocaine - adverse effects; Lip - surgery; Male; Medicine; Medicine & Public Health; Middle Aged; Original; Original Articles; Otorhinolaryngology; Plastic Surgery; Prospective Studies; Treatment Outcome; Stylage; Lip volume; Cross-linked; Dermal filler; Hyaluronic acid; Randomized controlled trial (RCT)
• ISSN: 0364-216X; 1432-5241; 1432-5241
• DOI: 10.1007/s00266-024-04398-z

Background Hyaluronic acid (HA) is a widely used dermal filler for lip augmentation. IPN-20-SENSE LIDOCAINE (Laboratoires VIVACY) is a monophasic gel consisting of cross-linked HA and includes lidocaine hydrochloride for the reduction of injection-associated pain. Aims The SMILE study was designed to assess the non-inferiority of IPN-20-SENSE LIDOCAINE compared to HA-RK-Lido in improving aesthetic lip appearance. The secondary objectives were to evaluate the effectiveness and safety of IPN-20-SENSE LIDOCAINE against the chosen similar active control device. Patients/Methods This was a prospective, multicenter, double-blinded, randomized active controlled parallel group study undertaken in two investigational sites between May 2021 and July 2022 (14 months). The primary endpoint of this study was the proportion of subjects reporting an improvement on the Global Aesthetic Improvement Scale (GAIS) 3 months after treatment initiation. Results Regarding the primary endpoint, the difference between the treatment arms in the proportion of improved subjects was +7.0 [-2.2; 17.7]. The lower limit of this 90% CI, being above the non-inferiority margin of -15 and below zero, demonstrated the non-inferiority of IPN-20-SENSE LIDOCAINE vs. HA-RK-Lido. The secondary outcomes reported by subjects and the blinded live evaluators supported this result. All injection site reactions and device-related adverse events reported in this study were expected, already described and were mostly mild and transient. Conclusions The study demonstrated the non-inferiority of IPN-20-SENSE LIDOCAINE to HA-RK-Lido in the aesthetic improvement of the lips. The effect of both treatments decreased over time. Nonetheless, aesthetic improvement was sustained longer in the IPN-20-SENSE LIDOCAINE arm. Level of Evidence I This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .