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Restylane + Lidocaine and Restylane Lyft for the Treatment of Nasolabial Folds

NCT04174131 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-04-10

No results posted yet for this study

Summary

This study is designed to assess and compare the efficacy of two hyaluronic acid (HA) fillers on moderate, severe and extreme nasolabial folds (NLF).

Conditions

  • Wrinkles Such as Nasolabial Folds

Interventions

DEVICE

Restylane + Lidocaine

Restylane + Lidocaine is a HA gel generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL with 0.3% lidocaine. It is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs.

DEVICE

Restylane® Lyft

Restylane® Lyft is a sterile gel of HA with lidocaine generated by Streptococcus species of bacteria, chemically cross-linked with BDDE (the cross linker), stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL. Lyft is intended to be used for facial tissue augmentation (Galderma Laboratories, 2014).

Sponsors & Collaborators

  • Erevna Innovations Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-13
Primary Completion
2019-12-12
Completion
2020-02-12

Countries

  • Canada

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 NCT04174131 on ClinicalTrials.gov