Injection Assistance Device Versus Manual Injections for Delivery of Dermal Fillers

Overview

The purpose of this study is to characterize the safety and performance in normal therapeutic use of the Artiste System in comparison to standard manual administration of dermal fillers. Subjects are recruited from the investigator's practice and randomized to receive treatment with the Artiste System on either the left or right nasolabial fold, the contralateral fold to be treated with standard manual injections. Treatments occur in a single session to achieve optimal cosmetic results (OCR) balanced on both sides. Investigators are encouraged to use a variety of types and brands of dermal fillers, recruiting subjects for the study as necessary. Safety and performance evaluations will be made through a combination of clinical observations, questionnaires for the subject and for the Treating Investigator, and spontaneous reports of adverse events. There are 6 required study visits: Screening, Day 1 (Treatment Day), Day 3, Day 8, Day 15, and Day 29.

This is a randomized, evaluator-blind, bilateral, controlled, multicenter study. Subjects are to be recruited from the investigator's practice and randomized to receive treatment with the Artiste System on either the left or right nasolabial fold, the contralateral fold to be treated with standard manual injections. Treatments will occur in a single session to achieve optimal cosmetic results (OCR) balanced on both sides. There are no specific requirements with respect to the type or brand of dermal filler to be used, but the investigators will be encouraged to use a variety of types and brands in the context of the study, recruiting subjects for the study as necessary. Safety and performance evaluations will be made through a combination of clinical observations (by a Blinded Evaluator distinct from the Treating Investigator), questionnaires for the subject and for the Treating Investigator, and spontaneous reports of adverse events. There will be a total of 6 required study visits: Screening, Day 1 (Treatment Day), Day 3, Day 8, Day 15, and Day 29.