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

NCT04813614 | Completed

• 1 other identifier: 2021-A00089-32
• Study Type: interventional
• Target: 92
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Esthetics

Keywords

hyaluronic acid; lips; volume; outline

Outcome Measures

Primary Outcomes (1)

• Subject self-assessed global aesthetic evolution of the lips

  Proportion of subjects having a positive aesthetic evolution on the 5-point Global Aesthetic Improvement Scale (GAIS) evaluated by the subject on the lips (after mirror self-examination), 3 months after treatment initiation (V1). Positive aesthetic evolution according to Global Aesthetic Improvement Scale (GAIS) corresponds to one of these three categories: "Very much improved", "Much improved" or "Improved". The 5-point GAIS contains the following categories: "Very much improved", "Much improved", "Improved", "No change" and "Worse".

  Month 3

Secondary Outcomes (6)

• Subject self-assessed global aesthetic evolution of the lips

  Month 1, Month 6, Month 9, Month 12

• Investigator's assessment of global aesthetic evolution of the lips

  Month 1, Month 3, Month 6, Month 9, Month 12

• Lips' surface aspect

  Month 1, Month 3, Month 6, Month 9, Month 12

• Evolution of subject's satisfaction

  Month 1, Month 3, Month 6, Month 9, Month 12

• Pain during injection

  Day 0, Month 1

Study Arms (2)

STYLAGE M Lidocaine

EXPERIMENTAL

The first injection is performed at visit 1 (V1) on Day 0 (D0). D0 is considered as the baseline. The maximum volume to be injected is 2 mL in total for lower and upper lips. The exact volume per lip will be determined by the physician/injector in order to reach optimal volume correction and/or lips' redefinition, as well as the injection technique(s) to be used. Injection is done into and/or around the lip mucosa by linear threading injection, multipoint injection, or a combination of both techniques with needle or cannula. One optional touch-up injection is allowed at visit 2 (V2) on Month 1 (M1), with a maximum volume to be injected of 1 mL in total for lower and upper lips. No other touch-up injection is allowed until the end of the study. A total maximum volume of 2.5 mL is recommended for both initial and touch-up injections combined (upper and lower lips).

Device: STYLAGE M Lidocaine

Active control group

ACTIVE COMPARATOR

The first injection is performed at visit 1 (V1) on Day 0 (D0). D0 is considered as the baseline. The maximum volume to be injected is 2 mL in total for lower and upper lips. The exact volume per lip will be determined by the physician/injector in order to reach optimal volume correction and/or lips' redefinition, as well as the injection technique(s) to be used. Injection is done into the submucosal layer of the lip by linear threading injection or serial puncture techniques injection with needle or cannula. One optional touch-up injection is allowed at visit 2 (V2) on Month 1 (M1), with a maximum volume to be injected of 1 mL in total for lower and upper lips. No other touch-up injection is allowed until the end of the study. A total maximum volume of 2.5 mL is recommended for both initial and touch-up injections combined (upper and lower lips).

Device: Active control group

Interventions

STYLAGE M Lidocaine DEVICE

Injection in the lips

STYLAGE M Lidocaine

Active control group DEVICE

Injection in the lips

Active control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteer.
• Sex: female or male.
• Age: between 18 and 65 years.
• Subject having given freely and expressly his/her informed consent and data privacy consent.
• Subject who expressed the wish for augmentation or restoration of the volume of the lips and/or lips' outline redefinition.
• Lips requiring volume and/or lips' outline requiring redefinition according to the investigator's judgement.
• Subject with attainable expectations for lips' volume augmentation or restoration and/or outline redefinition.
• Subject willing to have photographs of the face taken.
• Subject psychologically able to understand the study related information and to give a written informed consent.
• Subject able and agreeing to follow study procedures, instructions and likely to complete all required visits.
• Subject affiliated to a health social security system.
• Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before screening visit and during all the study.
• Subject agreeing to be treated with hyaluronidase product in case of vascular complication at the injection site.

You may not qualify if:

• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• Subject in a social or sanitary establishment.
• For France only: subject having received 4500 euros indemnities for participation in researches involving human beings in France in the 12 previous months, including participation in the present study).
• Pregnant or breastfeeding woman or planning a pregnancy during the study.
• Subject with scar(s), mole(s) or anything on the studied zones, which might interfere with the evaluation (tattoo, permanent make-up…), including lips presenting a marked asymmetry (especially when smiling) and missing front tooth or teeth.
• Subjects with severe perioral wrinkles and seeking for upper cutaneous lip or perioral rejuvenation.
• Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results and/or subject safety (e.g. on-going active infection).
• Subject suffering from epilepsy, impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction.
• Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
• Subjects suffering from porphyria.
• Subject having history of allergy or anaphylactic shock including known hypersensitivity to one of the ingredient of tested devices (i.e. hyaluronic acid, lidocaine) or to any other component of the devices used in this study, to gram-positive bacterial proteins, to antiseptic solution or to amide-type local anaesthetics.
• Subject with a history of streptococcal disease, such as acute rheumatic fever, especially with cardiac localisation or recurrent sore throats.
• Subject with a tendency to develop keloids or hypertrophic scars or any other healing disorders.
• Subject with bleeding, haemostatic disorders.
• Subject having received treatment with a laser, a dermabrasion, a surgery, a chemical peeling or any other procedure based on active dermal response on/around the lips within the past 12 months prior to screening visit or who plans to undergo any of these procedures during the study.

Sponsors & Collaborators

• Laboratoires Vivacy: lead
• Eurofins: collaborator
• Inferential: collaborator

Study Sites (2)

Eurofins Dermscan Pharmascan

Villeurbanne, 69100, France

Location

Eurofins Dermscan Poland

Gdansk, 80-288, Poland

Location

Study Officials

• Julia Gotlib, MD

  Coordinating investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subjects randomized in the study will be blinded to the treatment administered by using a blindfold during injection session(s). All the evaluators and operators who will take part in the investigation will be different than the legally qualified clinical practitioners who will realize injections and will be blinded to the treatment administered: * Live blinded independent evaluators will oversee the inclusions of subjects, the follow-up of subject's tolerance and the scoring in live of the GAIS (also using the photograph taken at V1 before first injection as a reference). The same blinded independent evaluator will follow-up the same subjects over the study period as far as possible. * Technicians who will oversee the photographs taking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, double blinded, randomized, active controlled, multicenter study (post-market clinical follow-up).

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: May 31, 2021
• Primary Completion: October 11, 2021
• Study Completion: July 12, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

FR (1); PL (1)