NCT03381040

Midfacial Product Selection

Predictive Algorithm for Product Selection in the Management of Mid Facial Volume Correction: Part I - A Pilot Validation of Patient Strata

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Erevna Innovations Inc. · Academic / Other
• Sex: Female
• Age: 30 Years – 75 Years
• Healthy volunteers: Accepted

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)?

Detailed description

With age, loss of facial fat and hollowing of the cheeks can result in a "sinking" appearance in the mid-face. Augmentation and contouring of the area can be corrected using dermal fillers such as Restylane. Currently, product choice and amount of volume used for injectable procedures varies between physicians as there is no standard for treatment. Individual assessment based on the attending physician's preference and experience determines final product selection and technique. An algorithm is needed to standardize best practices between physicians and clinics and to better regulate the use of dermal fillers in facial plastic surgery. Therefore, the purpose of this study is to is to develop an algorithm to decide on which product (i.e., Restylane Volyme or Lyft) to use in the cheek area based on subject characteristics such as age, skin quality, subcutaneous fat quantity and positioning, and bony structure.

Conditions

• Facial Volume Loss

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-12-05
• Primary completion: 2018-08-15
• Completion: 2019-01-08
• First posted: 2017-12-21
• Last updated: 2019-01-10

Locations

1 site across 1 country: Canada