Injection Assistance Device Versus Manual Injections for Delivery of Dermal Fillers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by TKL Research, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Nordson Micromedics
Information provided by (Responsible Party):
TKL Research, Inc.
ClinicalTrials.gov Identifier:
NCT01492140
First received: December 7, 2011
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Correction of Nasolabial Folds
Procedure: Subdermal Injection
Device: Artiste Assisted Injection System
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by TKL Research, Inc.:

Primary Outcome Measures:
  • Injection Site Reactions [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Severity ratings.

  • Patient Acceptability [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Questionnaire

  • Investigator Acceptability [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Questionnaire


Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492140

Locations
United States, New York
Z. Paul Lorenc
New York, New York, United States, 10028
United States, Texas
Suzanne Bruce & Associates
Houston, Texas, United States, 77056
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99204
Sponsors and Collaborators
TKL Research, Inc.
Nordson Micromedics
Investigators
Principal Investigator: Z. Paul Lorenc, MD Independent
  More Information

No publications provided

Responsible Party: TKL Research, Inc.
ClinicalTrials.gov Identifier: NCT01492140     History of Changes
Other Study ID Numbers: NM-11-01
Study First Received: December 7, 2011
Last Updated: December 12, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 22, 2014