NCT04101825

MD Auralia (HA Filler) in Treatment of Nasolabial Wrinkles

Open, Non-comparative Study to Evaluate the Performance and Safety of the Medical Device AURALYA® (Hyaluronic Acid-dermal Filler) in the Treatment of Nasolabial Wrinkles to Obtain Facial Rejuvenation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: I.R.A. Istituto Ricerche Applicate S.p.A. · Network
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Nasolabial Fold, Hypoplastic

Interventions

Type	Name	Description
DEVICE	Auralya	Hyaluronic Acid-Dermal Filler

Timeline

• Start date: 2020-09-16
• Primary completion: 2021-03-16
• Completion: 2021-03-16
• First posted: 2019-09-24
• Last updated: 2021-04-12

Locations

1 site across 1 country: Romania