CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Auralyadevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04101825
NCT04101825N/ACompleted
CompareCT.gov

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

I.R.A. Istituto Ricerche Applicate S.p.A.·interventional·Posted Sep 24, 2019·Updated Apr 12, 2021

In Brief

A clinical study evaluating Auralya for Nasolabial Fold, Hypoplastic. Completed, enrolled 60 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasolabial Fold, Hypoplastic
CountriesRomania
CollaboratorsOpera CRO, a TIGERMED Group Company

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 24, 2019
Enrollment StartSep 16, 2020
Primary CompletionMar 16, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.8 years ago

Interventions

Auralyadevice

Hyaluronic Acid-Dermal Filler