Injection Assistance Device Versus Manual Injections for Delivery of Dermal Fillers
Status unconfirmed · Phase 4
Conditions studied: Correction of Nasolabial Folds
In brief
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.
Key facts
- Study ID
- NCT01492140
- Run by
- TKL Research, Inc.
- People needed
- 50
- Starts
- 2011-12-01
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2011-12-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- Z. Paul Lorenc — New York, New York, United States
- Suzanne Bruce & Associates — Houston, Texas, United States
- Premier Clinical Research — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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