Improvement of Jawline ContourNCT03583359
Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline
A study testing Radiesse (+) in people with Improvement of Jawline Contour, run by Merz North America, Inc. at 15 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Improvement of Jawline Contour
- What is being tested?
- Radiesse (+)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 15 sitesUnited States
- Study dates
- 6 Aug 2018to 27 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has right and left jawline ratings of 2 or 3 (moderate or severe) on the Merz Jawline Assessment Scale (MJAS).
- Has the same MJAS score on both jawlines (that is, jawlines are symmetrical).
- Is greater than or equal to (>=) 22 and less than or equal to (<=) 65 years of age.
Who cannot join
- Ever been treated with fat injections or permanent fillers (example, silicone, polymethylmethacrylate (PMMA)) in the lower face and/or jawline area or plans to receive such treatments during participation in the study.
- Been treated with semi-permanent dermal fillers (example, poly L-lactic acid) in the lower face and/or jawline area in the past 5 years or plans to receive such treatments during participation in the study.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Westlake Dermatology, Merz Investigational Site #0010322
Austin, Texas, 78746
Clinical Testing of Beverly Hills, Merz Investigational Site #0010395
Beverly Hills, California, 90210
Clinical Research Center of the Carolinas, Merz Investigational Site #0010417
Charleston, South Carolina, 29407
Dermatology, Laser & Vein Specialists of the Carolinas, Merz Investigational Site #0010194
Charlotte, North Carolina, 28207
SkinCare Physicians of Chestnut Hill. Merz Investigational #0010098
Chestnut Hill, Massachusetts, 02467
Skin Research Institute, Merz Investigational Site #0010101
Coral Gables, Florida, 33146
AboutSkin Research LLC, Merz Investigational Site #0010103
Greenwood Village, Colorado, 80111
MD Laser Skin & Vein Institute, Merz Investigational Site #0010323
Hunt Valley, Maryland, 21030
Skin Care Center, Merz Investigational Site #0010099
Los Angeles, California, 90069
Lupo Center for Aesthetic and General Dermatology, Merz Investigational Site #0010418
New Orleans, Louisiana, 70124
Skinfluence Medical PC, Merz Investigational #0010421
New York, New York, 10028
Bass Plastic Surgery PLLC, Merz Investigational Site #0010419
New York, New York, 10065
Ava MD, Merz Investigational Site #0010299
Santa Monica, California, 90404
Moradi MD Face Beautiful Inc, Merz Investigational Site #0010358
Vista, California, 92083
Research Institute of the Southeast, LLC, Merz Investigational Site #0010420
West Palm Beach, Florida, 33401
About this study
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.
- Conditions
- Improvement of Jawline Contour
- Being tested
- Radiesse (+)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiesse (+)Device
Also called Radiesse (+) Injectable Dermal Filler with Lidocaine
Radiesse (+) for jawlines.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Radiesse (+) | Experimental | Not described Receives: Device: Radiesse (+) |
| Control/Delayed Treatment with Radiesse (+) | Other | Not described Receives: Device: Radiesse (+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate According to the Merz Jawline Assessment Scale (MJAS)
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.
Measured: At Week 12
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
Measured: Baseline up to end of study (Week 60)
Secondary outcomes (4)
Percent Change From Baseline in Face-Q Satisfaction
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).
Measured: Baseline up to Week 12
Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator
GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).
Measured: At Week 12
GAIS Scores as Assessed by Participants
GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).
Measured: At Week 12
Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs)
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.
Measured: At Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start6 Aug 2018
- Primary completion27 Mar 2020
- Study completion27 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Improvement of Jawline ContourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583359
- Sponsor's protocol ID
- M900391004
- Status last verified
- Nov 2023
- First submitted
- 28 Jun 2018
- Last updated
- 14 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Moradi A, Green J, Cohen J, Joseph J, Dakovic R, Odena G, Verma A, Scher R. Effectiveness and Safety of Calcium Hydroxylapatite With Lidocaine for Improving Jawline Contour. J Drugs Dermatol. 2021 Nov 1;20(11):1231-1238. doi: 10.36849/jdd.6442.
PubMed 34784131Moradi A, Dakovic R. Plain language summary of the pivotal study of calcium hydroxylapatite with lidocaine for improvement of jawline contour. J Dermatolog Treat. 2024 Dec;35(1):2421435. doi: 10.1080/09546634.2024.2421435. Epub 2024 Nov 6.
PubMed 39505354Green JB, Del Campo R, Durkin AJ, Funt DK, Nasrallah N, Martinez K, Moradi A. Long-term duration and safety of Radiesse (+) for the treatment of jawline. J Cosmet Dermatol. 2024 Oct;23(10):3202-3209. doi: 10.1111/jocd.16436. Epub 2024 Jun 27.
PubMed 38934231
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline
- ClinicalTrials.gov ID
- NCT03583359
- Acronym / sponsor ID
- M900391004
- Conditions
- Improvement of Jawline Contour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Posted 28 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Radiesse (+) | Experimental | Device: Radiesse (+) |
| Control/Delayed Treatment with Radiesse (+) | Other | Device: Radiesse (+) |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has right and left jawline ratings of 2 or 3 (moderate or severe) on the Merz Jawline Assessment Scale (MJAS).
- Has the same MJAS score on both jawlines (that is, jawlines are symmetrical).
- Is greater than or equal to (>=) 22 and less than or equal to (<=) 65 years of age.
Key exclusion criteria (2 listed)
- Ever been treated with fat injections or permanent fillers (example, silicone, polymethylmethacrylate (PMMA)) in the lower face and/or jawline area or plans to receive such treatments during participation in the study.
- Been treated with semi-permanent dermal fillers (example, poly L-lactic acid) in the lower face and/or jawline area in the past 5 years or plans to receive such treatments during participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiesse (+)Also: Radiesse (+) Injectable Dermal Filler with LidocaineRadiesse (+) for jawlines. | Device | Control/Delayed Treatment with Radiesse (+), Treatment with Radiesse (+) |
Primary outcome
Responder Rate According to the Merz Jawline Assessment Scale (MJAS)
Time frame: 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.
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
Time frame: Baseline up to end of study (Week 60)
4 secondary outcomes
Percent Change From Baseline in Face-Q Satisfaction
Time frame: Baseline up to Week 12
Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator
Time frame: At Week 12
GAIS Scores as Assessed by Participants
Time frame: At Week 12
Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs)
Time frame: At Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34784131Moradi A, Green J, Cohen J, Joseph J, Dakovic R, Odena G, Verma A, Scher R. Effectiveness and Safety of Calcium Hydroxylapatite With Lidocaine for Improving Jawline Contour. J Drugs Dermatol. 2021 Nov 1;20(11):1231-1238. doi: 10.36849/jdd.6442.
- Derived from this study: PubMed 39505354Moradi A, Dakovic R. Plain language summary of the pivotal study of calcium hydroxylapatite with lidocaine for improvement of jawline contour. J Dermatolog Treat. 2024 Dec;35(1):2421435. doi: 10.1080/09546634.2024.2421435. Epub 2024 Nov 6.
- Derived from this study: PubMed 38934231Green JB, Del Campo R, Durkin AJ, Funt DK, Nasrallah N, Martinez K, Moradi A. Long-term duration and safety of Radiesse (+) for the treatment of jawline. J Cosmet Dermatol. 2024 Oct;23(10):3202-3209. doi: 10.1111/jocd.16436. Epub 2024 Jun 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merz Medical Expert study director
Merz North America, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiesse (+) in people with Improvement of Jawline Contour, run by Merz North America, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Rate According to the Merz Jawline Assessment Scale (MJAS) (time frame: At Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03583359, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.