MedTrace Logo

Midfacial Product Selection

NCT03381040 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-01-10

No results posted yet for this study

Summary

This study seeks to determine whether patients pursuing injectable treatments for facial volume loss and/or contour deficiency can be separated into strata based on characteristics such as skin envelope and subcutaneous tissue quantity in the zygomatic, submalar and anteromedial cheek regions in order to guide the clinician in making the ideal product choice (i.e., Restylane Volyme vs Lyft)?

Conditions

  • Facial Volume Loss

Interventions

DEVICE

Restylane Lyft

Restylane® Lyft is a sterile gel of hyaluronic acid 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. It is recommended that the product be used for shaping the contours of the face and the correction of folds using the co-packed needles. Given the very high lift capacity of Lyft, it is often used when the skin envelope is normal or thicker than normal, as the contours of the product may be palpable in the presence of thin skin.

DEVICE

Restylane Volyme

Restylane® Volyme is a sterile, biodegradable, viscoelastic, non-pyrogenic, clear, colorless, and homogeneous soft hyaluronic acid gel with a high lifting capacity. Volyme is intended for injection into the supraperiostic zone or subcutis to augment the volume of the cheeks. Given Volyme's viscoelastic and lifting capacities, it is best used when there is significant loss of volume and a thin skin envelope.

Sponsors & Collaborators

  • Erevna Innovations Inc.

    lead OTHER

Principal Investigators

  • Andreas Nikolis, MD · Erevna Innovations Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-12-05
Primary Completion
2018-08-15
Completion
2019-01-08

Countries

  • Canada

Study Locations

More Related Trials

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 NCT03381040 on ClinicalTrials.gov