RADIESSE Injectable Implant for correcting moderate to severe nasolabial folds
Official title: A Prospective, Open-Label, Multicenter, Post-Market Clinical Follow-Up Study to Confirm the Long-term Safety and Effectiveness of RADIESSE® Injectable Implant for the Correction of Moderate to Severe Nasolabial Folds
Run by Merz North America, Inc. · NCT07856797 · Data updated 2026-11-12
This study tests RADIESSE Injectable Implant to see if it is safe and effective for adults in China with noticeable nasolabial folds.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 163 (estimated) |
| Sponsor | Merz North America, Inc. Industry-sponsored |
| Locations | 8 sites (Beijing and 7 other locations) |
| Status | Recruiting |
| Started | October 27, 2026 |
| Main results expected | August 2027 |
| Study ends | February 2029 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07856797 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with moderate to severe nasolabial folds (WSRS 3 or 4) who are willing to avoid other NLF treatments during the study.
✕Probably not a fit
Individuals with minimal wrinkle severity, prior detectable filler in the NLF area, active infection, or recent facial treatments may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates the long-term safety and effectiveness of the RADIESSE Injectable Implant for filling moderate to severe nasolabial folds in Chinese adults. Participants receive treatment in both sides of the face and may get an optional touch-up at one month, with follow-up through 24 months after the last treatment. The study monitors safety, degradation profile, and aesthetic results using standard facial grading scales. Eligibility requires defined wrinkle severity and a commitment to avoid other facial treatments in the NLF area during participation. Exclusion criteria rule out prior identifiable filler material in the area, active infection, recent fillers, and recent facial procedures that could affect assessments.
Why it matters
Potential benefit: If successful, participants may experience longer-lasting improvement in nasolabial fold appearance with a predictable safety profile.
How similar studies have gone: Previous studies of RADIESSE in facial wrinkles have shown durable correction and acceptable safety in varied populations.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Merz Investigative Site
Beijing, China Recruiting -
Merz Investigative Site
Changde, China Recruiting -
Merz Investigative Site
Chengdu, China Recruiting -
Merz Investigative Site
Gaozhou, China Recruiting -
Merz Investigative Site
Hangzhou, China Recruiting -
Merz Investigative Site
Nanjing, China Recruiting
Show 2 more locations
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Merz Investigative Site
Xianyang, China Recruiting -
Merz Investigative Site
Yibin, China Recruiting
Study contacts
- Study coordinator: Public Disclosure Manager
- Email: Aesthetic.Trials@merz.com
- Phone: +1 984-301-3095
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.