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Safety and Effectiveness of ELLANSÉ®-S Dermal Filler in the Treatment of Nasolabial Folds
Condition: Nasolabial Folds · Sponsor: AQTIS Medical B.V.
About this study
The study will be a prospective, randomized, multi-center, split-face, controlled, double-blind clinical trial to evaluate the safety and effectiveness of ELLANSÉ®-S for the treatment of NLFs. Subjects will be randomized to receive treatment (ELLANSÉ®-S) in one NLF and control (Radiesse®) in the contralateral NLF. A total of 126 subjects will be treated. The control and test articles will be supplied in sterile ready-to-use, pre-filled syringes. Initial treatment and any 4-week touch-up will be done consistent with initial randomization. Any retreatment(s) in either NLF will be with ELLANSÉ®-S. Subjects who meet Inclusion/Exclusion criteria will receive an initial treatment, an optional touch up at the 4-week visit, and may be eligible to receive retreatment at either 12 or 18 months after treatment (determined by when the fold has returned to baseline score, or the fold has lost at least 1 point on the Wrinkle Severity Rating Scale (WSRS) from optimal improvement). Retreatment to one side is allowed if only one side qualifies, but the other side may not be retreated at a later visit. If retreatment occurs, the subject may also be eligible to receive an optional touch up at the 4-week follow up visit. If a touch up occurs after the initial or retreatment injection, the subject will return for an additional safety visit 2 weeks after each injection. A week 4 safety visit will occur after retreatment touch-up. Primary effectiveness will be assessed at 6 months. All subjects wi…
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
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Locations (7)
| Investigate MD | Scottsdale, Arizona, United States | — |
| Clinical Testing of Beverly Hills | Encino, California, United States | — |
| DMR Research, PLLC | Westport, Connecticut, United States | — |
| Skin Research Institute LLC | Miami, Florida, United States | — |
| Callender Center for Clinical Research | Glenn Dale, Maryland, United States | — |
| Skincare Physicians | Chestnut Hill, Massachusetts, United States | — |
| Advanced Dermatology of Michigan | Warren, Michigan, United States | — |
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Source record: clinicaltrials.gov/study/NCT06984835