Auralya® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation. To evaluate the overall safety of the medical device and performance of Auralya® dermal filler in terms of absolute change of WSRS score (Wrinkle Severity Rating Scale) assessed by Investigator at 8 and 12 weeks after the initiation of treatment, compared to Baseline Visit (day 0).
Minimally invasive procedures (injectable dermal fillers) are among the techniques preferred by an increasing number of specialists in Aesthetics due to their clinical performance regarding volume restoration, and favourable safety profile. During January - March 2018, it was performed a review of the scientific literature to find similar investigations to determine the minimal clinical significant difference between Baseline and a period of 30 days after the end the treatment. In a similar dermal filler study, Takanobu Mashiko et al used a 5-grade WSRS and showed that, at 4 weeks after treatment, they achieved a 1.7 ± 0.5 (mean ± SD) improvement between those visits. Considering the exploratory nature of this study and the fact that this investigation is first in-human, we choose to take a 0.5 WSRS decrease, at 90 days from the treatment start, as a minimal clinically significant difference. The standard deviation considered for the sample size calculation was set at 0.8 WSRS points. By using a one-sided Wilcoxon Signed-rank test (matched pairs), a significance level of 0.05 and a power of 0.95 (probability of finding an effect when there is one), we calculated a total sample size of 31 subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
60
Hyaluronic Acid-Dermal Filler
SCM Dr. Rosu
Timișoara, Timiș County, Romania
Evaluate safety and performance of Auralya
To evaluate the overall safety of the medical device and performance of Auralya® dermal filler in terms of absolute change of Wrinkle Severity Rating Scale assessed by Investigator at 8 and 12 weeks after the initiation of treatment, compared to Baseline Visit (day 0).
Time frame: 12 weeks
Change of Wrinkle Severity Rating Scale
Absolute change of WSRS score assessed by the subject at 2, 4, 8 and 12 weeks compared to Baseline Visit (day 0).
Time frame: 12 weeks
General appearance after treatment
General appearance after treatment assessed by the subject at 2, 4, 8 and 12 weeks after the first treatment session compared to Baseline Visit (day 0) using the Global Aesthetic Improvement Scale (GAIS)
Time frame: 12 weeks
Subject satisfaction
Subject satisfaction assessed at 2, 4, 8 and 12 weeks, through Treatment Satisfaction Questionnaire completed by the subject providing their degree of satisfaction with the treatment on a three-point scale (very satisfied, satisfied, or not satisfied)
Time frame: 12 weeks
Global evaluation of product performance
Global evaluation of product performance by Investigator with photos taken at each visit. The photos will be compared in the final visit (week 12)
Time frame: 12 weeks
Product safety
Global evaluation of product safety by Investigator and by the patient using Patient Global Assessment of Safety questionnaire
Time frame: 12 weeks
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