Injection Assistance Device Versus Manual Injections for Delivery of Dermal Fillers

NCT01492140 | Unknown Phase 4

• 1 other identifier: NM-11-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (3)

• Injection Site Reactions

  Severity ratings.

  4 weeks

• Patient Acceptability

  Questionnaire

  4 weeks

• Investigator Acceptability

  Questionnaire

  4 weeks

Interventions

Subdermal Injection PROCEDURE

Injection of dermal filler

Artiste Assisted Injection System DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TKL Research, Inc.: lead
• Nordson Micromedics: collaborator

Study Sites (3)

Z. Paul Lorenc

New York, New York, 10028, United States

Location

Suzanne Bruce & Associates

Houston, Texas, 77056, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

Study Officials

• Z. Paul Lorenc, MD

  Independent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 14, 2011
• Study Start: December 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: December 14, 2011

Record last verified: 2011-12

Locations

US (3)