Status:
UNKNOWN
Injection Assistance Device Versus Manual Injections for Delivery of Dermal Fillers
Lead Sponsor:
TKL Research, Inc.
Collaborating Sponsors:
Nordson Micromedics
Conditions:
Correction of Nasolabial Folds
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 Syst...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01492140
Start Date
December 1 2011
End Date
February 1 2012
Last Update
December 14 2011
Active Locations (3)
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1
Z. Paul Lorenc
New York, New York, United States, 10028
2
Suzanne Bruce & Associates
Houston, Texas, United States, 77056
3
Premier Clinical Research
Spokane, Washington, United States, 99204