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NCT07856797
A Study to Confirm Safety and Effectiveness of RADIESSE® Injectable Implant for the Correction of Moderate to Severe Nasolabial Folds
Conditions: Nasolabial Folds
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 163
Sponsor: Merz North America, Inc.
Summary
The purpose of this study is to confirm the long-term safety, effectiveness, and degradation profile of RADIESSE® Injectable Implant for the correction of moderate to severe nasolabial folds (NLFs) in Chinese adults. Eligible participants will receive treatment with RADIESSE® Injectable Implant in both NLFs and may receive an optional touch-up treatment at Month 1 at investigator's discretion. Participants will be followed for up to 24 months after last treatment.
Eligibility Criteria
Inclusion Criteria:
* WSRS score of 3 (moderate) or 4 (severe) in both right and left NLFs, as determined live by the treating investigator. The WSRS score for the right and the left NLF does not have to be equal.
* Willing to abstain from other aesthetic treatments in the NLF area during study participation.
Exclusion Criteria:
* Prior dermal filler or implant material detectable in the NLF area by ultrasound.
* Active infection or acute inflammation at treatment sites.
* Hyaluronic Acid or collagen filler treatment in NLFs within 12 months.
* CaHA or Poly L-Lactic Acid filler treatment in NLFs within 24 months.
* Recent facial dermal therapies in the midface region within the past 6 months.
* Prior facial surgery or implants that could interfere with assessments.
Source: ClinicalTrials.gov (NCT07856797). StuddyBuddy aggregates publicly available trial information.