NCT03583359

Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline

Completed NA Results posted Last updated 14 November 2023

What this trial tests

NA trial testing Radiesse (+) in Improvement of Jawline Contour in 180 participants. Completed in 27 March 2020.

Timeline

6 August 2018

Primary endpoint
27 March 2020

27 March 2020

Quick facts

Lead sponsor	Merz North America, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	180
Start date	6 August 2018
Primary completion	27 March 2020
Estimated completion	27 March 2020
Sites	15 locations across United States

Drugs / interventions tested

• Radiesse (+)

Conditions studied

• Improvement of Jawline Contour — all drugs for Improvement of Jawline Contour →

Sponsor

Merz North America, Inc. — full company profile →

Who can join

Adults 22 to 65, any sex, with Improvement of Jawline Contour. 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.

Responder Rate According to the Merz Jawline Assessment Scale (MJAS) Primary · At Week 12

MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a greater than or equal to (\>=) 1-point improvement.

Group	Value	95% CI
Treatment With Radiesse (+)	75.6	67.3 – 82.3
Control/Delayed Treatment With Radiesse (+)	8.8	3.8 – 18.9

Number of Participants Reporting One or More Device and/or Injection Related Treatment-emergent Adverse Events (TEAEs) and Device and/or Injection Related Serious TEAEs Primary · Baseline up to end of study (Week 60)

Participants with Device and/or Injection Related TEAEs

Group	Value	95% CI
Treatment With Radiesse (+)	36
Control/Delayed Treatment With Radiesse (+)	10

Participants with Device and/or Injection Related Serious TEAEs

Group	Value	95% CI
Treatment With Radiesse (+)	0
Control/Delayed Treatment With Radiesse (+)	0

Percent Change From Baseline in Face-Q Satisfaction Secondary · Baseline up to Week 12

The participant assessed satisfaction using the Face-Q Satisfaction with Lower Face and Jawline module (Rasch transformed score 0-100; higher scores mean better outcome).

Group	Value	95% CI
Treatment With Radiesse (+)	269.8	215.1 – 324.6
Control/Delayed Treatment With Radiesse (+)	-9.4	-28.2 – 9.5

Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator Secondary · At Week 12

GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).

Group	Value	95% CI
Treatment With Radiesse (+)	37
Treatment With Radiesse (+)	51
Treatment With Radiesse (+)	27
Treatment With Radiesse (+)	1

GAIS Scores as Assessed by Participants Secondary · At Week 12

GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).

Group	Value	95% CI
Treatment With Radiesse (+)	32
Treatment With Radiesse (+)	38
Treatment With Radiesse (+)	39
Treatment With Radiesse (+)	6

Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs) Secondary · At Week 12

MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a \>=1-point improvement.

Group	Value	95% CI
Treatment With Radiesse (+)	47.7	38.7 – 57.0
Control/Delayed Treatment With Radiesse (+)	8.2	3.2 – 19.2

Adverse events — posted to ClinicalTrials.gov

Time frame: From first treatment up to the end of study (Week 60). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment With Radiesse (+)

Serious: 1/122 (1%)

Deaths: 0/122

Control/Delayed Treatment With Radiesse (+)

Serious: 2/53 (4%)

Deaths: 0/53

Serious adverse events (3 terms)

Reaction	System	Treatment With Radiesse (+)	Control/Delayed Treatment …
Cholecystitis	Hepatobiliary disorders	—	—
Erysipelas	Infections and infestations	—	—
Hypertension	Vascular disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Treatment With Radiesse (+)	Control/Delayed Treatment …
Injection site mass	General disorders	—	—
Injection site bruising	General disorders	—	—
Injection site pain	General disorders	—	—

Most-reported serious reactions: Cholecystitis, Erysipelas, Hypertension.

Data from ClinicalTrials.gov NCT03583359 adverse events section.

Sponsor's own description

To demonstrate the effectiveness and safety of Radiesse (+) following deep (subdermal and/or supraperiosteal) injection to improve the contour of jawline by adding volume to the jawline.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Long-term duration and safety of Radiesse (+) for the treatment of jawline.
   Green JB, Del Campo R, Durkin AJ, Funt DK, et al · · 2024 · cited 5× · PMID 38934231 · DOI 10.1111/jocd.16436
2. Plain language summary of the pivotal study of calcium hydroxylapatite with lidocaine for improvement of jawline contour.
   Moradi A, Dakovic R. · · 2024 · PMID 39505354 · DOI 10.1080/09546634.2024.2421435