Trial Outcomes & Findings for Evaluation of the MJGS Following Radiesse (+) Injection Into the Jawline (NCT NCT02904057)

NCT ID: NCT02904057

Last Updated: 2020-12-10

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

29 participants

Primary outcome timeframe

Week 4

Results posted on

2020-12-10

Participant Flow

The study was conducted at 2 sites in Canada.

A total of 29 participants were screened for the study and all 29 participants were enrolled and treated.

Participant milestones

Participant milestones
Measure	Treatment Group: Radiesse (+) Injectable Implant Participants received Radiesse+Lidocaine Injectable Implant up to 3.0 cubic centimeter (cc) volume, once within the jawline region of anterior to posterior boundaries (from the mentum to the earlobe) and superior to inferior boundaries (from the lower cheek to the lower body of the jawline).	Control Group: Untreated Participants did not receive jawline treatment.
Overall Study STARTED	19	10
Overall Study COMPLETED	19	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the MJGS Following Radiesse (+) Injection Into the Jawline

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group: Radiesse (+) Injectable Implant n=19 Participants Participants received Radiesse+Lidocaine Injectable Implant up to 3.0cc volume, once within the jawline region of anterior to posterior boundaries (from the mentum to the earlobe) and superior to inferior boundaries (from the lower cheek to the lower body of the jawline).	Control Group: Untreated n=10 Participants Participants did not receive jawline treatment.	Total n=29 Participants Total of all reporting groups
Age, Continuous	56.3 years STANDARD_DEVIATION 7.01 • n=5 Participants	59.2 years STANDARD_DEVIATION 6.39 • n=7 Participants	57.3 years STANDARD_DEVIATION 6.83 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	10 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	19 Participants n=5 Participants	8 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Fitzpatrick skin type Type I	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Fitzpatrick skin type Type II	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Fitzpatrick skin type Type III	10 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants
Fitzpatrick skin type Type IV	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Fitzpatrick skin type Type V	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Fitzpatrick skin type Type VI	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: The full analysis set (FAS) comprised of the subset of participants in the randomized set for whom the primary efficacy variable was available.

Outcome measures

Outcome measures
Measure	Treatment Group: Radiesse (+) Injectable Implant n=38 Jawlines Participants received Radiesse+Lidocaine Injectable Implant up to 3.0cc volume, once within the jawline region of anterior to posterior boundaries (from the mentum to the earlobe) and superior to inferior boundaries (from the lower cheek to the lower body of the jawline).	Control Group: Untreated n=20 Jawlines Participants did not receive jawline treatment.
Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4 Imputed data	92.1 percentage of jawlines	0 percentage of jawlines
Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4 Observed data	92.1 percentage of jawlines	0 percentage of jawlines

SECONDARY outcome

Timeframe: Week 4

Population: The FAS comprised the subset of participants in the randomized set for whom the primary efficacy variable was available. The GAIS was assessed only in treated subjects (i.e., not in Control Group: Untreated); therefore, the analysis is on observed cases, where data were available for both assessments.

MJGS is a 5-point scale, where score ranges from (0-4) as, score 0: continuous jawline contour, no downshifting of subcutaneous volume; score 1: mild loss of jawline contour, mild downshifting of subcutaneous volume; score 2: moderate loss of jawline contour, moderate downshifting of subcutaneous volume; score 3: severe loss of jawline contour, severe downshifting of subcutaneous volume, and; score 4: very severe loss of jawline contour, diffuse mandibular angle, very severe downshifting of subcutaneous volume. The GAIS is a 7-point scale, where score ranges from (0-7) as: score 0: very much worse; score 1: much worse; score 3: worse; score 4: no change; score 5: improved; score 6: much improved; score 7: very much improved. An "improvement" on the GAIS for the treating investigator was classified as investigators who rated participants as "improved", "much improved", or "very much improved". All other ratings on the GAIS were classified as "no improvement".

Outcome measures

Outcome measures
Measure	Treatment Group: Radiesse (+) Injectable Implant n=38 Jawlines Participants received Radiesse+Lidocaine Injectable Implant up to 3.0cc volume, once within the jawline region of anterior to posterior boundaries (from the mentum to the earlobe) and superior to inferior boundaries (from the lower cheek to the lower body of the jawline).	Control Group: Untreated Participants did not receive jawline treatment.
Treatment Group, Radiesse (+) Injectable Implant: Percentage of Jawlines With >=1-point Improvement on the MJGS Versus at Least an Improved Rating on Global Aesthetic Improvement Scale (GAIS) at Week 4 GAIS improvement and MJAS ≥ 1-grade improvement	92.1 percentage of jawlines	—
Treatment Group, Radiesse (+) Injectable Implant: Percentage of Jawlines With >=1-point Improvement on the MJGS Versus at Least an Improved Rating on Global Aesthetic Improvement Scale (GAIS) at Week 4 iGAIS improvement and MJAS no improvement	7.9 percentage of jawlines	—
Treatment Group, Radiesse (+) Injectable Implant: Percentage of Jawlines With >=1-point Improvement on the MJGS Versus at Least an Improved Rating on Global Aesthetic Improvement Scale (GAIS) at Week 4 iGAIS no improvement and MJAS ≥ 1-grade improvement	0 percentage of jawlines	—
Treatment Group, Radiesse (+) Injectable Implant: Percentage of Jawlines With >=1-point Improvement on the MJGS Versus at Least an Improved Rating on Global Aesthetic Improvement Scale (GAIS) at Week 4 iGAIS no improvement and MJAS no improvement	0 percentage of jawlines	—

Adverse Events

Treatment Group: Radiesse (+) Injectable Implant

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Control Group: Untreated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Group: Radiesse (+) Injectable Implant n=19 participants at risk Participants received Radiesse+Lidocaine Injectable Implant up to 3.0cc volume, once within the jawline region of anterior to posterior boundaries (from the mentum to the earlobe) and superior to inferior boundaries (from the lower cheek to the lower body of the jawline).	Control Group: Untreated n=10 participants at risk Participants did not receive jawline treatment.
General disorders Injection site bruising	26.3% 5/19 • Number of events 7 • Baseline up to Week 4 The investigator asked the participant for adverse events (AEs) systematically at each visit.	0.00% 0/10 • Baseline up to Week 4 The investigator asked the participant for adverse events (AEs) systematically at each visit.
General disorders Injection site swelling	63.2% 12/19 • Number of events 23 • Baseline up to Week 4 The investigator asked the participant for adverse events (AEs) systematically at each visit.	0.00% 0/10 • Baseline up to Week 4 The investigator asked the participant for adverse events (AEs) systematically at each visit.
General disorders Nodule	5.3% 1/19 • Number of events 1 • Baseline up to Week 4 The investigator asked the participant for adverse events (AEs) systematically at each visit.	0.00% 0/10 • Baseline up to Week 4 The investigator asked the participant for adverse events (AEs) systematically at each visit.
General disorders Pain	5.3% 1/19 • Number of events 1 • Baseline up to Week 4 The investigator asked the participant for adverse events (AEs) systematically at each visit.	0.00% 0/10 • Baseline up to Week 4 The investigator asked the participant for adverse events (AEs) systematically at each visit.
Skin and subcutaneous tissue disorders Erythema	57.9% 11/19 • Number of events 22 • Baseline up to Week 4 The investigator asked the participant for adverse events (AEs) systematically at each visit.	0.00% 0/10 • Baseline up to Week 4 The investigator asked the participant for adverse events (AEs) systematically at each visit.

Additional Information

Public Disclosure Manager

Merz Pharmaceuticals GmbH

Phone: +49 69 1503 1

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
Publication restrictions are in place

Restriction type: OTHER