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.
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 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
64
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).
Eurofins Dermscan Pharmascan
Villeurbanne, France
Difference of aesthetic improvement on the Wrinkle Severity Rating Scale (WSRS),
First co-primary endpoint will be the difference of aesthetic improvement on the Wrinkle Severity Rating Scale (WSRS), as evaluated by the BLE, at the side of the face treated with Stylage® M lidocaïne compared to the side of the face treated with Stylage® M, in a double non-inferiority statistical model.
Time frame: 6 months
Within-subject difference in injection site pain
Second co-primary endpoint will be the (STYLAGE® M Side - STYLAGE® M lidocaine Side), self-assessed by the subjects on a 100 mm Visual Analogue Scale (VAS), in a superiority statistical model.
Time frame: immediatly after injection of each side
WSRS change from baseline
WSRS change from baseline as assessed by the Blinded Live Evaluator (BLE)
Time frame: 4 days, 3, and 12 months after baseline
WSRS change from baseline on photographs
WSRS change from baseline as assessed by an Independent Photographic Reviewer (IPR), on photographs.
Time frame: 14 days, 3, 6, and 12 months after baseline
Responder rate for WSRS in live
Responder rate for WSRS , as assessed by the BLE. A responder is defined as a subject with at least 1-point improvement from baseline on the WSRS.
Time frame: 14 days, 3, 6, and 12 months after baseline
Responder rate for WSRS on photograph
Responder rate for WSRS , as assessed by an Independent Photographic Reviewer (IPR), on photographs.
Time frame: 14 days, 3, 6 and 12 months after baseline
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Global Aesthetic Improvement assessed by the BLE
Global Aesthetic Improvement assessed by the BLE on the Global Aesthetic Improvement Scale (GAIS).
Time frame: 14 days, 3, 6, and 12 months after baseline
Global Aesthetic Improvement assessed by the Subject
Global Aesthetic Improvement assessed by the Subject on the Global Aesthetic Improvement Scale (GAIS).
Time frame: 14 days, 3, 6, and 12 months after baseline
Proportions of GAIS responders assessed by the BLE
Proportions of GAIS responders defined as subjects with a GAIS score " Improved ", " Much Improved ", or " Very Much Improved ", as assessed by the BLE
Time frame: 14 days, 3, 6, and 12 months after baseline.
Proportions of GAIS responders assessed by the subjects
Proportions of GAIS responders defined as subjects with a Global Aesthetic " Improved ", " Much Improved ", or " Very Much Improved ", as assessed by the subjects
Time frame: 14 days, 3, 6, and 12 months after baseline.
Subject Satisfaction questionnaire
Proportion of subjects either " Somehow satisfied ", " Satisfied ", or " Very Satisfied ", as assessed by the subjects
Time frame: 14 days, 3, 6, and 12 months
Injection Site Pain self-assessed by the subjects (touch-up)
Injection Site Pain during injection self-assessed by the subjects of each side during optional touch-up treatment (VAS 100mm).
Time frame: immediatly after touch-up injection
Injection Site Pain self-assessed by the subjects (initial and touch-up)
Injection Site Pain self-assessed by the subjects at during initial and optional touch-up treatment.
Time frame: 5, 15, and 30 minutes post-injection
Proportion of subjects who reported at least 10 mm, 20 mm, and 30 mm less VAS pain (initial and touch-up).
Proportion of subjects who reported at least 10 mm, 20 mm, and 30 mm less VAS pain associated with injections of Stylage® M Lidocaïne compared to Stylage® M, immediately after injection (initial and touch-up).
Time frame: immediately after injection, and at 5, 15, and 30 minutes after each injection
Proportion of subjects that reported at least half less VAS pain (initial and touch-up)
Proportion of subjects that reported at least half less VAS pain associated with injections of Stylage® M Lidocaïne compared to Stylage® M (initial and touch-up).
Time frame: Immediately after injection, and at 5, 15, and 30 minutes after each injection
Injection site reaction and adverse events reporting
Product tolerance will be assessed by collection of Injection Site Reactions (ISRs) after each injection session, and Adverse Events throughout the study.
Time frame: up to 12 months