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Injection Assistance Device Versus Manual Injections for Delivery of Dermal Fillers

NCT01492140 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-12-14

No results posted yet for this study

Summary

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.

Conditions

  • Correction of Nasolabial Folds

Interventions

PROCEDURE

Subdermal Injection

Injection of dermal filler

DEVICE

Artiste Assisted Injection System

The Artiste™ Assisted Injection System is an air-powered device used to assist clinicians in injecting fluids into the body. The Artiste System was designed specifically to assist in the delivery of dermal fillers for the aesthetic correction of facial wrinkles, folds, and scars.

Sponsors & Collaborators

  • Nordson Micromedics

    collaborator UNKNOWN

  • TKL Research, Inc.

    lead INDUSTRY

Principal Investigators

  • Z. Paul Lorenc, MD · Independent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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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 NCT01492140 on ClinicalTrials.gov