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A Study to Confirm Safety and Effectiveness of RADIESSE® Injectable Implant for the Correction of Moderate to Severe Nasolabial Folds

RecruitingNAAges 18 Years - anyAllMerz North America, Inc.
NCT07856797 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Subdermal Implant
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Where

8 sites
Merz Investigative Site
Beijing, China
Merz Investigative Site
Changde, China
Merz Investigative Site
Chengdu, China
Merz Investigative Site
Gaozhou, China
Merz Investigative Site
Hangzhou, China
Merz Investigative Site
Nanjing, China
Merz Investigative Site
Xianyang, China
Merz Investigative Site
Yibin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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