The primary objective of the study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.
This is a multicenter, prospective, randomized, no-treatment controlled post-market clinical follow-up of a class III medical device. This study is designed to evaluate the safety and effectiveness of STYLAGE® XXL in the restorationor creation of volume in the mid-face. The objective of this study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face. Assessment of superiority will be based on 3D analysis of the volumetric change, using a validated imaging system. Effectiveness of STYLAGE® XXL will be demonstrated if the mean volumetric change at 24 weeks after baseline from pre-treatment in the treatment group is statistically superior to the mean change in the delayed treatment (control) group. In total, approximately 90 subjects will be enrolled across three study centers in Switzerland, Austria, and France. Subjects will be randomized to the treatment group or delayed treatment (control) group at a 5:1 ratio (i.e., there will be 5 more subjects treated with STYLAGE® XXL at baseline as compared to subjects who will be in the no-treatment (control) group and who will receive a delayed treatment with STYLAGE® XXL at 24 weeks after baseline). The total duration of subject participation ranges from 18-19 months (treatment group) to 24-25 months (delayed treatment (control) group). Overall study duration including the enrolment period is expected to take approximately 30-31 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Up to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek at the first session, on each side of the face. Up to 1.0 mL in the zygomaticomalar region and optionally up to 1.0 mL in the anteromedial cheek for the optional touch-up session, on each side of the face. Up to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek before study exit, on each side of the face.
Up to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek at the first session, on each side of the face. Up to 1.0 mL in the zygomaticomalar region and optionally up to 1.0 mL in the anteromedial cheek for the optional touch-up session, on each side of the face. Up to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek before study exit, on each side of the face.
Centre Medical Saint Jean
Arras, France
Mid-Face Volumetric change
Mean volumetric change between the treatment group and no-treatment control group at 24 (V4) weeks after baseline (V1)
Time frame: 24 weeks after baseline
Mid-Face Volumetric change
Mean volumetric change between the treatment group and no-treatment control group at 4 (V2) and 12 (V3) weeks after baseline (V1)
Time frame: 4, and 12 weeks after baseline
Mid-Face Volumetric change
Mean volumetric change between pre-treatment and directly after treatment at V1 (or V1b), and 4 (V2/V2b), 12 (V3/V3b), 48 (V5), and 72 (V6) weeks after initial treatment, in both groups pooled.
Time frame: 4, 12, 24, 48, and 72 weeks after initial treatment
Global Aesthetic Improvement, by the Subjects
Global Aesthetic Improvement Scale (GAIS; improvement in the mid-face Area), assessed by the Subjects, between the treatment group and no-treatment control group. GAIS (Global Aesthetic Improvement Scale) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, with higher scores mean better improvement, with 1 means "Worse" and 5 means "Very much improved".
Time frame: 4, 12, and 24 weeks after baseline
Global Aesthetic Improvement, by the Subjects
Global Aesthetic Improvement Scale (GAIS; improvement in the mid-face Area), assessed by the Subjects, in both groups pooled. GAIS (Global Aesthetic Improvement Scale) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, with higher scores mean better improvement, with 1 means "Worse" and 5 means "Very much improved".
Time frame: 4, 12, 24, 48, and 72 weeks after initial treatment
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Global Aesthetic Improvement, by the Investigators
Global Aesthetic Improvement Scale (GAIS; improvement in the mid-face Area), assessed by the Investigators, between the treatment group and no-treatment control group. GAIS (Global Aesthetic Improvement Scale) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, with higher scores mean better improvement, with 1 means "Worse" and 5 means "Very much improved".
Time frame: 4, 12, and 24 weeks after baseline
Global Aesthetic Improvement, by the Investigators
Global Aesthetic Improvement Scale (GAIS; improvement in the mid-face Area), assessed by the Investigators, in both groups pooled. GAIS (Global Aesthetic Improvement Scale) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, with higher scores mean better improvement, with 1 means "Worse" and 5 means "Very much improved".
Time frame: 4, 12, 24, 48, and 72 weeks after initial treatment
FACE-Q, by the Subjects
Rash-transformed score of the FACE-Q, assessed by the Subjects, between the treatment group and no-treatment control group. FACE-Q is a patient-reported outcome (PRO) measure that can be used to measure outcomes of aesthetic facial procedures and products from the patient's perspective, composed of a set of independently functioning scales/checklists. In this study; two scales are assessed: 1. FACE-Q - Satisfaction with cheekbones: This questionnaire consists of 10 items, and measures the appearance of cheekbones with items that ask about shape, contour and symmetry, as well as how attractive, high and well-defined the cheekbones look. 2. FACE-Q - Satisfaction with outcome. This questionnaire consists of 6 items, and measures satisfaction with the result of a facial procedure, e.g., pleased with the result, result is fantastic. The total score is converted to a score from 0 to 100, with higher scores reflect a better outcome.
Time frame: Baseline, and 4, 12, and 24 weeks after baseline
FACE-Q, by the Subjects
Rash-transformed score of the FACE-Q, assessed by the Subjects, in both groups pooled. FACE-Q is a patient-reported outcome (PRO) measure that can be used to measure outcomes of aesthetic facial procedures and products from the patient's perspective, composed of a set of independently functioning scales/checklists. In this study; two scales are assessed: 1. FACE-Q - Satisfaction with cheekbones: This questionnaire consists of 10 items, and measures the appearance of cheekbones with items that ask about shape, contour and symmetry, as well as how attractive, high and well-defined the cheekbones look. 2. FACE-Q - Satisfaction with outcome. This questionnaire consists of 6 items, and measures satisfaction with the result of a facial procedure, e.g., pleased with the result, result is fantastic. The total score is converted to a score from 0 to 100, with higher scores reflect a better outcome.
Time frame: Initial treatment, and 4, 12, 24, 48, and 72 weeks after initial treatment
Wrinkle Severity Rating Scale (WSRS), by the Investigators.
Nasolabial Fold Severity using the wrinkle severity rating scale (WSRS), assessed by the Investigators, between the treatment group and no-treatment control group. The WSRS (Wrinkle Severity Rating Scale) is a 5-point rating scale to determine the severity of the nasolabial folds (NLF), with lower scores mean better condition (less severity), with 1 means "Absent - No visible NLF, continuous skin line" and 5 means "Extreme - Extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched".
Time frame: 4, 12, and 24 weeks after baseline
Wrinkle Severity Rating Scale (WSRS), by the Investigators.
Nasolabial Fold Severity using the wrinkle severity rating scale (WSRS), assessed by the Investigators, in both groups pooled. The WSRS (Wrinkle Severity Rating Scale) is a 5-point rating scale to determine the severity of the nasolabial folds (NLF), with lower scores mean better condition (less severity), with 1 means "Absent - No visible NLF, continuous skin line" and 5 means "Extreme - Extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched".
Time frame: 4, 12, 24, 48, and 72 weeks after initial treatment
Ease of sculpting and massaging, by the Investigators
Ease of sculpting and massaging of the HA gel, assessed by the investigator after each treatment session, on a 5-point scale ranging from "Very easy" to "Very difficult", in both groups pooled.
Time frame: Initial treatment, and 4, and 72 weeks after initial treatment