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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
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).
Eurofins Dermscan Pharmascan
Villeurbanne, France
Eurofins Dermscan Poland
Gdansk, Poland
Mean change in nasolabial fold severity assessed in live
Mean change in nasolabial fold severity from baseline to 6 months after treatment initiation, as assessed by an independent blinded live evaluator using the validated 5-point Wrinkles Severity Rating Scale (WSRS). The Wrinkles Severity Rating Scale is a 5-grade scale (from grade 1 to grade 5) with minimum grade representing a better outcome. Grade 1 corresponds to "Absent", grade 2 to "Mild", grade 3 to "Moderate", grade 4 to "Severe" and grade 5 to "Extreme".
Time frame: Month 6
Mean change in nasolabial fold severity assessed in live
Mean WSRS change from baseline to 1, 3, 9 and 12 months after treatment initiation, as assessed by an independent blinded live evaluator using the validated 5-point Wrinkles Severity Rating Scale (WSRS).
Time frame: Month 1, Month 3, Month 9, Month 12
Mean change in nasolabial fold severity assessed on photographs
Mean WSRS change from baseline to 1, 3, 6, 9 and 12 months after treatment initiation as assessed by a blinded independent evaluator on photographs, using the validated 5-point Wrinkles Severity Rating Scale (WSRS).
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Evaluation of WSRS responder rate
WSRS responder rates 1, 3, 6, 9 and 12 months after treatment initiation as assessed by a blinded live independent evaluator and a blinded independent evaluator on photographs. A responder is defined as a subject with at least 1-point improvement from baseline on the WSRS.
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Evaluation of global aesthetic improvement
Mean global aesthetic improvement from 1, 3, 6, 9 and 12 months after treatment initiation by subjects and a blinded live independent evaluator using the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a 5-score scale (from score 1 to score 5) with minimum scores representing a better outcome. Score 1 corresponds to "Very improved", score 2 to "Much improved", score 3 to "Improved", score 4 to "No change" and score 5 to "Worse".
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Evaluation of GAIS responder rate
GAIS responder rates 1, 3, 6, 9 and 12 months after treatment initiation as assessed by subjects and a blinded live independent evaluator. A responder is defined as a subject having "Improved", "Much improved" or "Very much improved" score according to GAIS.
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Mean change in nasolabial fold depth
Mean change in nasolabial fold depth from baseline to 1, 3, 6, 9 and 12 months after treatment initiation using Dermatop®.
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Evaluation of subject's satisfaction
Evaluation of subject's satisfaction 1, 3, 6, 9 and 12 months after treatment initiation using a questionnaire.
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Evaluation of pain during injection
Evaluation of pain during injection by subjects on an 11-point numeric rating scale (0 to 10).
Time frame: Day 0, Month 1
Report of adverse events
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 Month 12
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