NCT03461198

Micro-injections of Transparent Hyaluronic Acid Gel (Restylane® Silk) for Rejuvenation of the Aging Cheek

A Single Center, Prospective, Open-label, Clinical Trial Using Micro-injections of Transparent Hyaluronic Acid Gel (Restylane® Silk) for Rejuvenation of the Aging Cheek

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to determine the efficacy and safety of Restylane® Silk microinjections when used in a grid-like injection pattern for the correction of fine lines to the cheeks.

Detailed description

This is a single center, prospective, open-label, clinical trial using micro-injections of Restylane® Silk for correction of mid to low cheek fine lines and wrinkles. Twenty (20) subjects will be enrolled. Each subject will receive Restylane® Silk to a defined area of mid to low cheeks. The injections will be delivered intradermally via multiple 0.02 cc microinjections distributed in a grid array pattern with 1 cm between each injection point. A total surface area of 9-15 cm2 per cheek will be treated depending on the extent of fine lines in each subject. Following completion of injection treatment, manual massage will be applied to the full area to promote even distribution of the product. Each subject will undergo a total of three treatment sessions, one month apart, day 1, week 4, and week 8. The maximum amount of Restylane to be used per treatments session/per cheek is 1.5cc (not to exceed a total of 9 cc) per treated patient. Three dimensional digital photography utilizing the Vectra 3D System (Canfield) will be utilized to document pre-treatment status, sites of injection, and post-treatment effect. Subjects will be followed up at 4 weeks, 8 weeks, post-treatment day 90, and day 180.

Conditions

• Wrinkle

Interventions

Type	Name	Description
DEVICE	Restylane® Silk	Restylane® Silk to a defined area of mid to low cheeks

Timeline

• Start date: 2019-02-26
• Primary completion: 2020-04-01
• Completion: 2020-08-01
• First posted: 2018-03-09
• Last updated: 2019-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study