Evaluation of the filler performance on the nasolabial folds of Aliaxin® EV with and without lidocaine 0.3%: comparison within subjects (half face method)
Comparative, randomized, mono-centre spontaneous trial, under dermatological control, that foresaw the comparison within subjects of the investigational product versus investigational product with Lidocaine 0.3% (half face method); assignation of right or left face side to the two injective treatments was choose by the Investigator according to a previously defined randomisation list. Primary end point of the study was to evaluate the filling and bio-revitalizing activity on nasolabial folds of the product Aliaxin® EV Essential Volume, in women aged 40-65 years. It was also aim of this study to show if the addition of Lidocaine 0.3% to the investigational product (extemporaneous mixture) could have reduced the discomfort/pain sensation perceived by the subject during the injection procedure, without altering the aesthetic performance.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
The injective treatment was performed, during T0 visit after the basal evaluations, mono-laterally on nasolabial fold,(right or left face side in according to a previously defined randomisation list). A quantity of Aliaxin® Ev (up to a maximum of 0.5 ml) with Lidocaine 0.3% was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect.
The injective treatment was performed on the contralateral nasolabial fold during T0 visit, after the basal evaluations . A quantity of Aliaxin® Ev up to a maximum of 0.5 ml was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect.
DermIng S.r.l. Single Member Company
Monza, MB, Italy
Wrinkle Severity Rating Scale (WSRS) grade variation from baseline
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 visit (T0), Week 4 (T4)
The Global Aesthetic Improvement Scale (GAIS) grade variation from baseline
Aesthetic improvement in the subjects' midface from their pretreatment state according to a five point scale: 1. Very much improved: Optimal cosmetic result for the implant in this patient. 2. Much improved: Marked improvement in appearance from initial condition, but not completely optimal for this patient. A touch up will slightly improve the result. 3. Improved: Obvious improvement in appearance from the initial condition, but a touch-up or re-treatment is indicated. 4. No change: The appearance is essentially the same as the original condition. 5. Worse:The appearance in worst than the original condition.
Time frame: Baseline visit (T0), Week 4 (T4)
Self grading
Immediately and 2 hours after the aesthetic procedure, each volunteers scored its own sensations thanks to a visual analogic scale (VAS 10 units length) as follow: 1. Stinging (0= no stinging to 10= strong stinging) 2. Itching (0= no itching to 10= strong itching) 3. Tightening (0= no tightening to 10= strong tightening) 4. Burning (0= no burning to 10= strong burning) 5. Pain (0= no pain to 10= strong pain) 6. Discomfort (0= no discomfort to 10= strong discomfort) In order to highlight any differences between the side treated with the investigational product and the one treated with the study product + lidocaine 0.3%, the VAS score will be expressed separately for each of the two treated sides.
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Time frame: Immediately after the injection procedure (T0A), 2 hours after the injection procedure (T2h)
Determination of profilometric parameters
Variation from baseline of the nasolabial fold profilometric parameters versus baseline. Profilometric parameters are expressed in in micron. A picture of nasolabial fold area is taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to measure skin principal profilometric parameters:Ra (average roughness) Rt (wrinkles total high), Rv (wrinkles maximum depth)
Time frame: Baseline visit (T0), Week 4 (T4)