Injection Assistance Device Versus Manual Injections for Delivery of Dermal Fillers

A Randomized, Evaluator-Blind, Bilateral Comparison of an Injection Assistance Device Versus Manual Injections for Delivery of Dermal Fillers in Patients Seeking Aesthetic Correction of the Nasolabial Folds

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.

Study Overview

• Status: Unknown
• Conditions: Correction of Nasolabial Folds
• Intervention / Treatment: Procedure: Subdermal Injection; Device: Artiste Assisted Injection System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10028
      • Z. Paul Lorenc
  • Texas
    • Houston, Texas, United States, 77056
      • Suzanne Bruce & Associates
  • Washington
    • Spokane, Washington, United States, 99204
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, at least 18 years of age;
• Presenting at Screening with bilateral nasolabial folds rated 2 or greater on the Wrinkle Severity Rating Scale (SRS) by the Blinded Evaluator.
• Willing and able to provide informed consent;
• In good health, based upon the subject's report and medical history.

Exclusion Criteria:

• History of keloids, bleeding disorders, or severe allergic or anaphylactic reactions, including hypersensitivity to any components of the study materials;
• Active inflammatory process, scarring, or dense facial hair in the area of the nasolabial folds;
• Any chronic or acute medical condition that, in the opinion of the investigator, may interfere with evaluation of the study results or place the subject at undue risk;
• History of previous cosmetic treatment of the nasolabial folds within 6 months prior to the Screening visit;
• Planning to undergo facial surgery during the 4-week course of the study;
• Participation in a clinical investigation within the 30 days prior to the Screening visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injection Site Reactions	Severity ratings.	4 weeks
Patient Acceptability	Questionnaire	4 weeks
Investigator Acceptability	Questionnaire	4 weeks

Collaborators and Investigators

• Sponsor: TKL Research, Inc.
• Collaborators: Nordson Micromedics
• Investigators: Principal Investigator: Z. Paul Lorenc, MD, Independent

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ANTICIPATED): February 1, 2012
• Study Completion (ANTICIPATED): February 1, 2012

Study Registration Dates

• First Submitted: December 7, 2011
• First Submitted That Met QC Criteria: December 12, 2011
• First Posted (ESTIMATE): December 14, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 14, 2011
• Last Update Submitted That Met QC Criteria: December 12, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: NM-11-01