Stylage® XL Lidocaïne is a CE-marketed hyaluronic acid gel indicated for the restoration or augmentation of facial volume by injection into the deep dermis or subcutaneously. Lidocaine hydrochloride is intended to reduce the pain associated with the injection. In this study 40 healthy subjects between the age of 30 and 65 years, presenting a volume deficit on the face as evaluated by the investigator at inclusion in the study, who have given his/her informed consent and met all the eligibility criteria, will be enrolled. Subjects will come to a total of 6 visits over a period of 18 months and a screening visit prior to baseline injection. The facial volume variation after baseline injection will be assessed. Treatment responders rate, Global Aesthetic Improvement, volume on the cheekbones, volume on the chin and chin angle (for applicable subjects), subject's satisfaction and safety will be also assessed.
This is a prospective, uncontrolled, single site study with a blinded evaluator assessing the efficacy of Stylage® XL Lidocaïne on FVLS and GAIS clinical scoring. The study duration by subject is 18 months with a screening visit (V0) before injection, the baseline visit (injection of Stylage® XL Lidocaïne, V1) and 5 follow-up visits after 1, 3, 6, 12 and 18 months (V2 to V6). At 1 month (V2) an optional touch-up may be done (if needed). The primary endpoint is the facial volume variation from baseline (D0) to 6 months after treatment initiation measured by an independent evaluator on photographs using FVLS (Facial Volume Loss Scale). Facial volume variation (evaluated by an independent evaluator) \& treatment responder rate, Global Aesthetic Improvement (evaluated by the patient and the doctor), volume on the cheekbones and chin \& chin angle (for applicable subjects), subject's satisfaction will be measured at all time-point with a FVLS, GAIS,3D QuantifiCare system, FACE-Q questionnaire (cheekbones and chin) respectively. Safety will be also assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
On V1 (D0), a total volume of 8 mL maximum can be used per subject on the whole face. On V2 (M1), a possible touch-up can be made according to the injector and subject's opinion which cannot exceed 4 ml.
Laboratoire DERMSCAN
Villeurbanne, Rhône, France
Variation of facial volume
Facial volume variation from baseline to 6 months after treatment initiation measured by an independent evaluator on photographs using FVLS (Facial Volume Loss Scale). Graded scale from 1-5; 5 being the most severe
Time frame: 6 months
Variation of facial volume
Facial volume variation from baseline to 1, 3, 12 and 18 months after treatment initiation measured by an independent evaluator on photographs using FVLS scale.Graded scale from 1-5; 5 being the most severe
Time frame: Month 1, Month 3, Month 12, Month 18
Treatment responders rate
Rate of treatment responders at 1, 3, 6, 12 and 18 months measured by an independent evaluator on photographs using FVLS scale. Graded scale from 1-5; 5 being the most severe
Time frame: Month 1, Month 3, Month 6, Month 12, Month 18
Global aesthetic improvement
Variation from baseline to 1, 3, 6, 12 and 18 months after treatment initiation of the global aesthetic improvement measured by an independent evaluator on photographs using the GAIS (Global Aesthetic Improvement Scale). 5 possibles grades : 1) Very much improved, 2) much improved, 3) improved, 4) no change, 5) worse
Time frame: Month 1, Month 3, Month 6, Month 12, Month 18
Patient self-assessed aesthetic improvement
Variation from baseline to 1, 3, 6, 12 and 18 months after treatment initiation of the global aesthetic improvement measured by subjects using the GAIS. 5 possibles grades : 1) Very much improved, 2) much improved, 3) improved, 4) no change, 5) worse
Time frame: Month 1, Month 3, Month 6, Month 12, Month 18
Variation of volume on the cheekbones, and on the chin for applicable subjects
Variation from baseline to 1, 3, 6, 12 and 18 months after treatment initiation of the volume on the cheekbones (upper part of the cheek) and on the chin, for applicable subjects, using the 3D QuantifiCare system.
Time frame: Month 1, Month 3, Month 6, Month 12, Month 18
Variation of the chin angle for applicable subjects
Variation from baseline to 1, 3, 6, 12 and 18 months after treatment initiation of the chin angle for applicable subjects using the 3D QuantifiCare system.
Time frame: Month 1, Month 3, Month 6, Month 12, Month 18
Evolution of subject's satisfaction
Evolution of subject's satisfaction from baseline to 1, 3, 6, 12 and 18 months after treatment initiation using the FACE-Q satisfaction with cheekbones and the FACE-Q satisfaction with chin questionnaires.
Time frame: Month 1, Month 3, Month 6, Month 12, Month 18
Report of adverse events
Evaluation of product tolerance by collection of adverse events.
Time frame: Month 1, Month 3, Month 6, Month 12, Month 18
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