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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Correction of Nasolabial Folds
- Sponsor
- TKL Research, Inc.
- Enrollment
- 50
- Locations
- 3
- Primary Endpoint
- Injection Site Reactions
- Last Updated
- 14 years ago
Overview
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.
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Injection Site Reactions
Time Frame: 4 weeks
Severity ratings.
Patient Acceptability
Time Frame: 4 weeks
Questionnaire
Investigator Acceptability
Time Frame: 4 weeks
Questionnaire