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Effectiveness and Safety of STYLAGE® L Lidocaïne in the Treatment of Nasolabial Folds

NCT04844216 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-08-04

No results posted yet for this study

Summary

STYLAGE® L Lidocaine is a CE-marked hyaluronic acid gel intended to fill skin depressions on the face by dermal injection. In this study, 50 healthy subjects between the age of 30 and 65, with moderate to severe nasolabial folds as assessed in live, who have given their informed consent and met all eligibility criteria, will be enrolled. Subjects will randomly receive injection of STYLAGE® L Lidocaine on one nasolabial fold and injection of an active comparator on the other nasolabial fold. A touch-up is possible if required one month after. Subjects will come to a total of 7 visits over a period of 12 months. Variation in severity score of nasolabial folds will be assessed in live and on photographs by independent evaluators. Variation in nasolabial fold depth, global aesthetic improvement, subject satisfaction, pain at injection site and safety will also be assessed.

Conditions

  • Aging

Interventions

DEVICE

STYLAGE® L Lidocaine

An injection of maximum 2 mL on one nasolabial fold is planned at Day 0. A touch-up of maximum 1 mL on the same nasolabial fold is possible 1 month after D0 (month 1).

DEVICE

Active control

An injection of maximum 2 mL on one nasolabial fold is planned at Day 0. A touch-up of maximum 1 mL on the same nasolabial fold is possible 1 month after D0 (month 1).

Sponsors & Collaborators

  • Laboratoires Vivacy

    lead INDUSTRY

Principal Investigators

  • Sophie CONVERSET-VIETHEL, MD · Cabinet de chirugie de la face et du cou

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-16
Primary Completion
2022-01-13
Completion
2022-07-06

Countries

  • France
  • Poland

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 NCT04844216 on ClinicalTrials.gov