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MD Auralia (HA Filler) in Treatment of Nasolabial Wrinkles

NCT04101825 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-04-12

No results posted yet for this study

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).

Conditions

  • Nasolabial Fold, Hypoplastic

Interventions

DEVICE

Auralya

Hyaluronic Acid-Dermal Filler

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • I.R.A. Istituto Ricerche Applicate S.p.A.

    lead NETWORK

Principal Investigators

  • Mihaela Fratila, MD · SCM Dr. Rosu

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2021-03-16
Completion
2021-03-16

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04101825 on ClinicalTrials.gov