N/A
N=207
Safety, Effectiveness and Participant Satisfaction Study of a Dermal Filler (of RADIESSE® (+) Lidocaine) in the Treatment of Ageing Signs in the Face
Signs of Facial Aging With Volume Loss in the Upper Cheeks, Nasolabial Folds and Marionette Lines
Bottom Line
View on ClinicalTrials.gov: NCT03650387 ↗Enrolled (actual)
207
Serious AEs
2.4%
Results posted
Jun 2021
Primary outcome: Primary: Responder Rate for Nasolabial Folds Based on the Blinded Rater's Evaluation on the Merz Nasolabial Folds Scale (MNLFS) at Week 12/16 (Depending on Touch-up) — 93.6 percentage of participants — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RADIESSE® (+) Lidocaine (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merz North America, Inc.
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate for Nasolabial Folds Based on the Blinded Rater's Evaluation on the Merz Nasolabial Folds Scale (MNLFS) at Week 12/16 (Depending on Touch-up) |
93.6 | < 0.0001 sig |
| PRIMARY Responder Rate for Marionette Lines Based on the Blinded Rater's Evaluation on the Merz Marionette Lines Scale (MMLS) at Week 12/16 (Depending on Touch-up) |
88.7 | < 0.0001 sig |
| PRIMARY Responder Rate for Cheek Fullness Based on the Blinded Rater's Evaluation on the Merz Upper Cheek Fullness Scale (MUCFS) at Week 12/16 (Depending on Touch-up) |
81.9 | < 0.0001 sig |
| PRIMARY Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) |
139; 133; 129; 142 | — |
| SECONDARY Responder Rate for Nasolabial Folds Based on the Blinded Rater's Evaluation on the MNLFS at Week 4 (Prior to Optional Touch-up), at Week 24/28, at Week 48/52, and at Week 72/76 (Depending on Touch-up) |
87.6; 78.2; 41.6; 23.3 | — |
| SECONDARY Responder Rate for Marionette Lines Based on the Blinded Rater's Evaluation on the MMLS at Week 4 (Prior to Optional Touch-up), at Week 24/28, at Week 48/52, and at Week 72/76 (Depending on Touch-up) |
86.6; 71.6; 35.6; 16.0 | — |
| SECONDARY Responder Rate for Cheek Fullness Based on the Blinded Rater's Evaluation on the MUCFS at Week 4 (Prior to Optional Touch-up), at Week 24/28, at Week 48/52, and at Week 72/76 (Depending on Touch-up) |
84.6; 72.9; 51.6; 30.9 | — |
| SECONDARY Number of Participants Based on Treating Investigator's Evaluation of the Global Aesthetic Improvement on the iGAIS at Week 4 (Prior to Optional Touch-up), Week 12/16, Week 24/28, Week 48/52, and Week 72/76 (Depending on Touch-up Performed) |
24; 23; 24; 26; 106; 102 | — |
| SECONDARY Number of Participants Based on Participant's Evaluation of the Global Aesthetic Improvement on the sGAIS at Week 4 (Prior to Optional Touch-up), Week 12/16, Week 24/28, Week 48/52, and Week 72/76 (Depending on Touch-up Performed) |
9; 7; 9; 9; 71; 70 | — |
Summary
The primary objective is to collect clinical data to confirm performance and safety for RADIESSE® (+) Lidocaine, when used in accordance with its labelling in the treatment of nasolabial folds, marionette lines and/or upper cheek volume loss.
Eligibility Criteria
Inclusion Criteria
- Male or female greater than or equal to (>=) 18 years old.
- Participants seeking for dermal filler/volumising treatment in at least two of the following indications:
- Nasolabial folds;
- Marionette lines;
- Cheek volume loss.
- Nasolabial folds volume deficit of moderate to very severe intensity (grade 2 to 4) on the Merz Nasolabial Folds Scale with symmetrical rating at Day 1 as determined by the blinded rater and confirmed by the treating investigator afterwards.
- Marionette lines volume deficit of moderate to very severe intensity (grade 2 to 4) on the Merz Marionette Lines Scale with symmetrical rating at Day 1 as determined by the blinded rater and confirmed by the treating investigator afterwards.
- Upper cheek volume deficit of moderate to very severe intensity (grade 2 to 4) on the Merz Upper Cheek Fullness Scale with symmetrical rating at Day 1 as determined by the blinded rater and confirmed by the treating investigator afterwards.
At least two of the inclusion criteria 3, 4, and 5 must be fulfilled. Depending on the fulfilled criteria, the respective indications will be treated.
Exclusion Criteria
- Any prior treatment with silicone, polymethyl methacrylate, fat injections, poly L-lactic acid or permanent dermal fillers in the face.
- Any prior facial surgery, including facial plastic surgery, thread lift, any unknown treatment, or any surgical permanent implant that could interfere with performance assessments.
- Prior treatment within the past 24 months with porcine based collagen fillers or with volumisers (e.g., Belotero® Volume or others) in the area to be treated.
- Prior treatment within the past 18 months with calcium hydroxylapatite in the area to be treated.
- Prior treatment within the past 12 months with hyaluronic acid in the area to be treated.
- Prior treatment within the past 6 months with facial dermal therapies (e.g. epilation, ultraviolet irradiation, radiofrequency, facial ablative or non-ablative laser treatment, microderm abrasion, mechanical or chemical peels, non-invasive skin-tightening [e.g., Ultherapy, Thermage] or surgical procedures) or plans to receive this during participation in the study.
Data sourced from ClinicalTrials.gov (NCT03650387). 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.