Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Moderate to Severe Nasolabial Folds
CompletedNAResults postedLast updated 23 January 2023
What this trial tests
NA trial testing Radiesse injectable implant (dermal filler) in Correction of Moderate to Severe Nasolabial Folds (NLFs) in 134 participants. Completed in 27 April 2022.
Adults 22 to 65, any sex, with Correction of Moderate to Severe Nasolabial Folds (NLFs). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS)Primary· Baseline and Week 24 after last injection, up to 28 weeks
Severity of the nasolabial folds (NLFs) was assessed and measured using the 5-point Wrinkle Severity Rating Scale (WSRS), where 1=absent and 5=extreme. A lower score indicates better outcome.
Baseline
Group
Value
95% CI
Restylane
3.4
± 0.50
Radiesse
3.4
± 0.50
Week 24
Group
Value
95% CI
Restylane
2.4
± 0.62
Radiesse
2.4
± 0.70
Proportion of Subjects With Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) for Each Nasolabial Fold (NLF) at Week 24Secondary· Week 24 after last injection, up to 28 weeks
The Investigator Global Aesthetic Improvement Scale is a subjective assessment where the treating physician describes the degree of improvement in facial appearance ranging from "Very much improved" (+3) to "Very much worse" (-3). The investigator was asked to rate each NLF separately and select the rating that best applied when asked "What is the overall impression of aesthetic change of the subject's NLF due to treatment, compared to the pretreatment photograph". Improvement was defined as a rating of +1, +2, or +3. The higher the iGAIS score, the greater the improvement. Proportion refers t
Group
Value
95% CI
Restylane
77.19
Radiesse
77.19
Proportion of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) for Each Nasolabial Fold (NLF) at Week 24Secondary· Week 24 after last injection, up to 28 weeks
The Subject Global Aesthetic Improvement Scale is a subjective self-assessment where the subject independently describes the degree of improvement in facial appearance ranging from "Very much improved" (+3) to "Very much worse" (-3). Subjects rated each NLF separately when asked "What is the overall impression of aesthetic change of your NLF due to treatment, compared to the pretreatment photograph?" Improvement is defined as a rating of +1, +2, or +3. The higher the sGAIS score, the greater the improvement. Proportion refers to percentage of participants.
Group
Value
95% CI
Restylane
80.70
Radiesse
82.46
Number of Subjects With Treatment-emergent Adverse Events (AE) Related to RadiesseSecondary· Baseline to week 48 after last injection, up to 52 weeks
Defined as AEs with onset at or after date of first administration of Radiesse. An AE was considered to be "related" if a causal relationship between Radiesse or the treatment procedure and the AE is at least reasonably possible.
Group
Value
95% CI
Radiesse
23
Adverse events — posted to ClinicalTrials.gov
Time frame: From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Restylane
Serious: 0/120 (0%)
Deaths: 0/120
Radiesse
Serious: 0/120 (0%)
Deaths: 0/120
Non-NLF
Serious: 7/120 (6%)
Deaths: 0/120
Serious adverse events (7 terms)
Reaction
System
Restylane
Radiesse
Non-NLF
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Parathyroid tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Other trials of Radiesse injectable implant (dermal filler)
Trials testing the same drug.
NCT03282357 — Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Nasolabial Folds in China
· NA
· completed
Other Merz North America, Inc. trials
Trials by the same sponsor.
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· NA
· completed
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NCT05784363 — A Study of NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face
· Phase 1
· completed
NCT05163353 — Evaluation of the Effectiveness and Safety of Diluted RADIESSE® in the Treatment of Décolleté Wrinkles
· NA
· completed
NCT04886232 — A Prospective, Multicenter, Randomized, Comparator-controlled, Evaluator-blinded Study to Evaluate the Safety and Effect
· NA
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merz North America, Inc.
Last refreshed: 23 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04647721.