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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07856797). StuddyBuddy aggregates publicly available trial information.