N/A
N=121
Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Moderate to Severe Nasolabial Folds
Correction of Moderate to Severe Nasolabial Folds (NLFs)
Bottom Line
View on ClinicalTrials.gov: NCT04647721 ↗Enrolled (actual)
121
Serious AEs
1.9%
Results posted
Jan 2023
Primary outcome: Primary: Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS) — 3.4; 3.4; 2.4; 2.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiesse injectable implant (dermal filler) (Device); Restylane injectable implant (dermal filler) (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Merz North America, Inc.
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS) |
3.4; 3.4; 2.4; 2.4 | — |
| SECONDARY Proportion of Subjects With Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) for Each Nasolabial Fold (NLF) at Week 24 |
77.19; 77.19 | — |
| SECONDARY Proportion of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) for Each Nasolabial Fold (NLF) at Week 24 |
80.70; 82.46 | — |
| SECONDARY Number of Subjects With Treatment-emergent Adverse Events (AE) Related to Radiesse |
23 | — |
Summary
Effectiveness: The purpose of this study is to demonstrate the non-inferiority of Radiesse (CaHA) to Restylane (HA) following subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs.
Safety: To evaluate the incidence and type of adverse events and serious adverse events.
Eligibility Criteria
Inclusion Criteria
- Has symmetrical NLFs, with the same WSRS score of 3 or 4 (moderate or severe) for both right and left NLFs, as determined on live assessment by the blinded evaluator.
- Is ≥ 22 and ≤ 65 years of age.
- Is willing to abstain from all other aesthetic treatments on any part of the face, including but not limited to injectable fillers, implants, neurotoxin, skin peels, laser treatments, surgical treatments, etc. for the trial's duration.
Exclusion Criteria
- Has an acute inflammatory process or active infection at the injection site.
- Has received mid- and/or lower-facial region treatments with any dermal fillers.
- Has received facial dermal therapies.
- Had prior surgery in the mid- and/or lower-facial area, including the NLFs, or has a permanent implant or graft in the mid- and/or lowerfacial area that could interfere with effectiveness assessments.
Data sourced from ClinicalTrials.gov (NCT04647721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.