Wrinkle Clinical Trial - Restylane Silk Microinjections to Cheeks

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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 the entire cheeks. The defined area will be defined as the following: line extending from the upper margin of the nasal ala to the upper margin of the tragus, from the tragus to 1 cm above the mandibular angle, from 1 cm above the mandibular angle to 1 cm above the pre-jowl sulcus, and from 1 cm above the pre-jowl sulcus to the upper margin of the nasal ala. The injections will be delivered intradermally via multiple 0.02 cc microinjections distributed in a grid array pattern with 1-2 cm between each injection point (see figure 1; injections will extend 1 cm above the illustration). 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. Objective measures of efficacy will be me performed pre-treatment, at day 90 and 180. ;

Study Design

Related Conditions & MeSH terms

Wrinkle

Clinical Trial Details

NCT number	NCT03742479
Study type	Interventional
Source	Goldman, Butterwick, Fitzpatrick and Groff
Contact	Shannon Quigley
Phone	858 657 1004
Email	SQuigley@CLDerm.com
Status	Recruiting
Phase	N/A
Start date	February 26, 2019
Completion date	February 2020

View Details

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