Volume Loss of the JawlineNCT02904057
Evaluation of the MJGS Following Radiesse (+) Injection Into the Jawline
A study testing Radiesse (+) Injectable Implant in people with Volume Loss of the Jawline, run by Merz North America, Inc..
Trial summary
This study will evaluate the sensitivity of the validated Merz Jawline Grading Scale (MJGS) to detect treatment effects following Radiesse (+) correction of subcutaneous volume loss and contour deficits of the jawline. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Volume Loss of the Jawline
- What is being tested?
- Radiesse (+) Injectable Implant
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has right and left jawlines with moderate to severe volume/contour loss as determined by a live, masked evaluator.
- Is at least 18 years of age.
- Understands and accepts the obligation not to receive any other procedures below the orbital rim including the neck during participation in the study.
- Understands and accepts the obligation and is logistically able to present for all scheduled study visits and meet all study requirements.
Who cannot join
- Has ever been treated with silicone, PMMA (polymethyl methacrylate), fat injections, poly-L-lactic acid (PLLA; Sculptra®) or permanent dermal fillers below the orbital rim including the neck.
- Has had surgery on the jawbone or has surgical permanent implant to the face or neck.
- Has bruxism, masseter muscle hypertrophy or asymmetry of masseter muscles, active temporomandibular joint (TMJ) disease or disorder, or active periodontal disease.
- Has any medical condition with the potential to interfere with the study or increase the risk of adverse events.
- Has undergone oral surgery recently or plans to undergo oral surgery procedures during participation in the study.
About this study
Official title: Evaluation of the Merz Jawline Grading Scale (MJGS) Following Radiesse (+)® Correction of Subcutaneous Volume Loss and Contour Deficits of the Jawline - a Canadian Pilot Study
This study will evaluate the sensitivity of the validated Merz Jawline Grading Scale (MJGS) to detect treatment effects following Radiesse (+) correction of subcutaneous volume loss and contour deficits of the jawline. Treatment effects detected on the MJGS will be correlated with assessments of aesthetic outcomes on the Global Aesthetic Improvement Scale (GAIS) and FACE-Q instrument
Read the detailed description
A prospective, open label study, in which both right and left jawlines will receive treatment with Radiesse (+). Subjects will be randomized in a 2:1 ratio to either a treatment group or an untreated control group. Jawlines will be assessed by masked evaluators on the MJGS. Treating physicians and treatment group subjects will assess satisfaction on the GAIS. Treatment group subjects will self-report aesthetic outcomes on the FACE-Q instrument.
Treatment subjects will be evaluated at enrollment, and 1, 2 and 4 weeks after enrollment. Control group subjects will be required to be evaluated at enrollment and 4 weeks after enrollment.
- Conditions
- Volume Loss of the Jawline
- Being tested
- Radiesse (+) Injectable Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiesse (+) Injectable ImplantDevice
Treated subjects will receive a maximum volume of 3.0 cc of Radiesse (+) per jawline.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | The treatment group will receive Radiesse (+) injectable implant up to 3.0 cc per jawline. Receives: Device: Radiesse (+) Injectable Implant |
| Control Group | No intervention | The control group is not treated. They will undergo assessments such as photographs, jaw grading and jaw function tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4
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.
Measured: Week 4
Secondary outcomes (1)
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
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".
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
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.
- Other trials for Volume Loss of the JawlineStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Kuligowski, MD,PHD,MBA, Study director, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904057
- Sponsor's protocol ID
- P140891
- Status last verified
- Jun 2017
- First submitted
- 13 Sep 2016
- Last updated
- 10 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Merz Jawline Grading Scale (MJGS) Following Radiesse (+)® Correction of Subcutaneous Volume Loss and Contour Deficits of the Jawline - a Canadian Pilot Study
- ClinicalTrials.gov ID
- NCT02904057
- Acronym / sponsor ID
- P140891
- Conditions
- Volume Loss of the Jawline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Posted 10 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the sensitivity of the validated Merz Jawline Grading Scale (MJGS) to detect treatment effects following Radiesse (+) correction of subcutaneous volume loss and contour deficits of the jawline. Treatment effects detected on the MJGS will be correlated with assessments of aesthetic outcomes on the Global Aesthetic Improvement Scale (GAIS) and FACE-Q instrument
Detailed description
A prospective, open label study, in which both right and left jawlines will receive treatment with Radiesse (+). Subjects will be randomized in a 2:1 ratio to either a treatment group or an untreated control group. Jawlines will be assessed by masked evaluators on the MJGS. Treating physicians and treatment group subjects will assess satisfaction on the GAIS. Treatment group subjects will self-report aesthetic outcomes on the FACE-Q instrument.
Treatment subjects will be evaluated at enrollment, and 1, 2 and 4 weeks after enrollment. Control group subjects will be required to be evaluated at enrollment and 4 weeks after enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Radiesse (+) Injectable ImplantThe treatment group will receive Radiesse (+) injectable implant up to 3.0 cc per jawline. |
| Control Group | No intervention | –The control group is not treated. They will undergo assessments such as photographs, jaw grading and jaw function tests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has right and left jawlines with moderate to severe volume/contour loss as determined by a live, masked evaluator.
- Is at least 18 years of age.
- Understands and accepts the obligation not to receive any other procedures below the orbital rim including the neck during participation in the study.
- Understands and accepts the obligation and is logistically able to present for all scheduled study visits and meet all study requirements.
Key exclusion criteria (5 listed)
- Has ever been treated with silicone, PMMA (polymethyl methacrylate), fat injections, poly-L-lactic acid (PLLA; Sculptra®) or permanent dermal fillers below the orbital rim including the neck.
- Has had surgery on the jawbone or has surgical permanent implant to the face or neck.
- Has bruxism, masseter muscle hypertrophy or asymmetry of masseter muscles, active temporomandibular joint (TMJ) disease or disorder, or active periodontal disease.
- Has any medical condition with the potential to interfere with the study or increase the risk of adverse events.
- Has undergone oral surgery recently or plans to undergo oral surgery procedures 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 (+) Injectable ImplantTreated subjects will receive a maximum volume of 3.0 cc of Radiesse (+) per jawline. | Device | Treatment Group |
Primary outcome
Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4
Time frame: Week 4
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.
1 secondary outcome
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
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Michael Kuligowski, MD,PHD,MBA study director
Study Director
Questions about this trial
What is this clinical trial studying?
A study testing Radiesse (+) Injectable Implant in people with Volume Loss of the Jawline, run by Merz North America, Inc..
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 4 inclusion and 5 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 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 10 Dec 2020). 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?
Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4 (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2020.