Aim of the study is to evaluate the re-volumizing performance and the duration effect of the product Aliaxin (new trademark) in women aged 40-65 years with midface volume defects due to aging mechanism.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
First treatment was performed during baseline visit, after the basal evaluations planned by the study procedure. 0.5-1.1 ml of Aliaxin (new trademark) for emi-face was injected by needle (25-27 G) and/or cannula (25 G, 40 mm). A touch-up treatment (0.5-1.1 ml of Aliaxin new trademark for subject) was performed after 3-4 weeks (T1) in order to treat possible asymmetry.
DERMING
Milan, MI, Italy
Wrinkle Severity Rating Scale (WSRS) grade variation
Reduction of wrinkles severity corresponding to a decrease from the baseline of the Wrinkle Severity Rating Scale (WSRS) clinical score where: * Grade 1 (absent): no visible nasolabial fold; continuous skin line. * Grade 2 (mild): shallow but visible nasolabial fold with a slight indentation; minor facial feature. * Grade 3 (moderate): moderately deep nasolabial folds; clear facial feature visible at normal appearance but not when stretched. * Grade 4 (severe): very long and deep nasolabial folds; prominent facial feature; \<2mm visible fold when stretched. * Grade 5 (very severe): extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched.
Time frame: Baseline (T0), 3-4 weeks after the 1st injection procedure (T1),2 months after the 1st injection procedure (T2),3 months after the 1st injection procedure (T3),6 months after the 1st injection procedure (T4),9 months after the 1st injection procedure(T5)
Facial Volume Loss Scale (FVLS) grade variation
Reduction of face volume loss corresponding to a decrease from the baseline of the Facial Volume Loss Scale (FVLS) where: * Grade 1: Mild flattening or shadowing of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). No prominent bony landmarks. No visibility of underlying musculature. * Grade 2: An intermediate point between grade 1 and grade 3. * Grade 3: Moderate concavity of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas. Prominence of bony landmarks. May have visibility of underlying musculature. * Grade 4: An intermediate point between grade 3 and grade 5. * Grade 5: Severe indentation of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). Severe prominence of bony landmarks. Clear visibility of underlying musculature.
Time frame: Baseline (T0), 3-4 weeks after the 1st injection procedure (T1),2 months after the 1st injection procedure (T2),3 months after the 1st injection procedure (T3),6 months after the 1st injection procedure (T4),9 months after the 1st injection procedure(T5)
Photographic documentation (3D pictures)
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Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system.
Time frame: Baseline (T0), 3-4 weeks after the 1st injection procedure (T1),2 months after the 1st injection procedure (T2),3 months after the 1st injection procedure (T3),6 months after the 1st injection procedure (T4),9 months after the 1st injection procedure(T5)
Face volume variation
Face volume image analysis was carried on the 3D pictures taken by Vectra H1 thanks to Vectra analysis module (VAM) software
Time frame: Baseline (T0), 3-4 weeks after the 1st injection procedure (T1),2 months after the 1st injection procedure (T2),3 months after the 1st injection procedure (T3),6 months after the 1st injection procedure (T4),9 months after the 1st injection procedure(T5)