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.
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.
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.
Single group
Subdermal Implant
DeviceParticipants will receive treatment with RADIESSE® Injectable Implant.
Percentage of Participants Achieving at Least a 1-point Improvement in Both NLFs From Baseline to Month 6 after Last Treatment on the Wrinkle Severity Rating Scale (WSRS), as Assessed Live by the Treating Investigator
Severity of the NLFs was assessed and measured using the 5-point WSRS, where 1=absent and 5=extreme. A lower score indicates better outcome.
Percentage of Participants Achieving Improvement (Score of 1, 2, 3) on the Investigator Global Aesthetic Improvement Scale (iGAIS) at Month 6 After Last Treatment, as Assessed Live by the Treating Investigator
The iGAIS is an assessment grading scale where the treating investigator describes the degree of improvement in facial appearance according to the GAIS, a 5-point scale ranging from 'Very Much Improved' (1) to 'Worse' (5). The investigator will be asked to rate the NLFs and select the rating that best applies when asked "What is the overall impression of aesthetic change of the participants NLFs due to treatment, compared to the pretreatment photograph". Improvement is defined as a rating of +1, +2, or +3. The higher the iGAIS score, the greater the improvement.
Percentage of Participants Achieving Improvement (Score of 1, 2, 3) on the Participant Global Aesthetic Improvement Scale (pGAIS) at Month 6 After Last Treatment, as Assessed Live by Participant
The pGAIS is a self-assessment grading scale where the participant independently describes the degree of improvement in facial appearance according to the GAIS, a 5-point scale ranging from 'Very Much Improved' (1) to 'Worse' (5). Participants will be asked to rate the NLFs and select the rating that best applies when asked "What is the overall impression of aesthetic change of your NLFs due to treatment, compared to the pretreatment photograph?" Improvement is defined as a rating of +1, +2, or +3. The higher the pGAIS score, the greater the improvement.
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