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Effectiveness and Safety of STYLAGE® M LIDOCAINE Versus STYLAGE® M in Filling Nasolabial Folds

NCT05087732 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-12-02

No results posted yet for this study

Summary

This clinical investigation is designed to compare the STYLAGE® M Lidocaïne to STYLAGE® M in terms of correction of nasolabial folds severity and pain felt by the subject, and to assess and compare the safety and effectiveness of both products.

Subjects with moderate to severe nasolabial folds will receive both treatments in a split-face design at D0, and a touch-up will be done 14 days after if necessary. The subjects will be followed-up over a 12-month period after initial injection.

Conditions

  • Aging

Interventions

DEVICE

STYLAGE® M Lidocaïne

Up to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 14 days after on the same nasolabial fold (touch-up).

DEVICE

STYLAGE® M

Up to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 14 days after on the same nasolabial fold (touch-up).

Sponsors & Collaborators

  • Laboratoires Vivacy

    lead INDUSTRY

Principal Investigators

  • Siham RHARBAOUI · Dermscan Pharmascan

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
2021-10-19
Primary Completion
2022-05-18
Completion
2022-11-24

Countries

  • France

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 NCT05087732 on ClinicalTrials.gov