Moderate to Severe Midface Volume DeficitNCT03321825
Evaluation of the Merz Cheek Fullness Assessment Scale in the Treatment of Midface Volume Deficit
A study testing Belotero® Volume Lidocaine in people with Moderate to Severe Midface Volume Deficit, run by Merz North America, Inc. at 3 sites in Canada.
Trial summary
Evaluation of the sensitivity of the Merz Cheeks Fullness Assessment Scale (MCFAS) and the clinical relevance of aesthetically pleasing outcomes by detecting changes in cheek appearance after Belotero® Volume Lidocaine injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Midface Volume Deficit
- What is being tested?
- Belotero® Volume Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 3 sitesCanada
- Study dates
- 29 Sep 2017to 8 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Has right and left cheek volume deficit with a rating of 2 or 3 (moderately or severely sunken cheeks) on the MCFAS as determined by the blinded evaluator.
- 2. Has the same MCFAS score on both cheeks (i.e., cheeks are symmetrical).
- 3. Is at least 18 years of age.
- 4. Understands and accepts the obligation not to receive any other procedures (i.e., dermal fillers, toxin treatments, facial ablative or fractional laser, microderm abrasion, chemical peels, non-invasive skin-tightening [e.g., Ultherapy, Thermage] and/or surgical procedures) in the face during participation in the study.
Who cannot join
- 1. Skin atrophy in the midfacial region other than that related to age.
- 2. Has gained or lost and ≥ 2 body mass index (BMI) units within the previous 90 days or has the intention to gain or lose a significant amount of weight during the course of the study.
- 3. Unphysiological skin laxity and/or sun damage beyond typical for the subject's age or subject plans to tan during the study period.
- 4. Acute inflammatory process or infection at the injection site (e.g., acne, eczema, streptococcus infections), or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of AEs.
- 5. Prior surgery, including midfacial plastic surgery, or has a permanent implant or graft in the midfacial region that could interfere with effectiveness assessments.
- 6. Undergone oral surgery in the past 30 days or plans to undergo oral surgery during participation in the study (i.e., orthodontia, extraction, implants).
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- 7. Ever been treated with fat injections or permanent and/or semi-permanent dermal fillers in the midfacial region or plans to receive such treatments during participation in the study.
- 8. Received midfacial region treatments with porcine-based collagen fillers or with Belotero Volume, JUVÉDERM VOLUMA®, or Restylane® Lyft, calcium hydroxylapatite (CaHA), poly L-lactic acid (PLLA), or mesotherapy within the past 24 months and/or with other hyaluronic acid (HA) products within the past 12 months or plans to receive such treatments during participation in the study.
- 9. Received facial dermal therapies (i.e., toxin treatments, facial ablative or fractional laser, microderm abrasion, chemical peels, non-invasive skin-tightening [e.g., Ultherapy, Thermage] and surgical procedures) in the midface region within the past 12 months or plans to receive them during participation in the study.
- 10. Facial nerve palsy or history of facial nerve palsy.
- 11. A history or documented evidence of an autoimmune disease (e.g., scleroderma, lupus erythematosus, rheumatoid arthritis).
- 12. A known bleeding disorder or has received or is planning to receive anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs (e.g., aspirin, ibuprofen), or other substances known to increase coagulation time (vitamins or herbal supplements, e.g., vitamin E, garlic, gingko), from 10 days before to 3 days after injection.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Institute of Cosmetic and Laser Surgery; Merz Inverstigational Site #0010409
Oakville, Ontario, L6J 7W5
Research Toronto; Merz Investigational Site #0010408
Toronto, Ontario, M4W 2N2
Cosmetic Dermatology Toronto Yorkville; Merz Investigational Site #'0010412
Toronto, Ontario, M5R 3N8
About this study
Evaluation of the sensitivity of the Merz Cheeks Fullness Assessment Scale (MCFAS) and the clinical relevance of aesthetically pleasing outcomes by detecting changes in cheek appearance after Belotero® Volume Lidocaine injection.
The safety objectives include the identification and description of adverse events (AEs), adverse device effects (ADEs), serious adverse events (SAEs), serious adverse device effects (SADEs), anticipated serious adverse device effects (ASADEs) and unanticipated adverse device effects (UADEs) during the course of the study. Additionally, common treatment site responses (CTRs) will be assessed.
- Being tested
- Belotero® Volume Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belotero® Volume LidocaineDevice
Also called Hyaluronic acid dermal filler containing 0.3% of lidocaine hydrochlorid
Mode of application: subdermal injection
| Study group | Role | What they receive |
|---|---|---|
| Belotero® Volume Lidocaine | Experimental | Subdermal injection Receives: Device: Belotero® Volume Lidocaine |
| No treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the responder rate between the treatment group and the untreated control group at Week 4, according to the Merz Cheeks Fullness Assessment Scale (MCFAS) as assessed by a blinded evaluator.
Treatment response is defined as ≥ 1-point improvement on both cheeks compared to baseline.
The MCFAS is a 5-point ordinal rating scale ranging from 0 (full cheek) to 5 (very severely sunken cheek).
Measured: Week 4
Secondary outcomes (6)
Descriptive summary of the FACE-Q satisfaction of the midface for treated subjects at baseline and Week 4
Subject's assessment is based on the entire face. FACE-Q scores are derived from questionaires 'satisfaction with cheeks' (including 5 questions relating to the satisfaction with cheek appearance, answers range from 1 (very dissatisfied) to 4 (very satisfied)), and the module 'patient-perceived age visual analogue scale' (VAS - scale ranging from -15 (15 years younger) to 15 (15 years older)).
Measured: Week 4
Average percent change of the FACE-Q satisfaction of the midface for treated subjects from baseline to Week 4
Subject's assessment is based on the entire face. FACE-Q scores are derived from questionaires 'satisfaction with cheeks' (including 5 questions relating to the satisfaction with cheek appearance, answers range from 1 (very dissatisfied) to 4 (very satisfied)), and the module 'patient-perceived age visual analogue scale' (VAS - scale ranging from -15 (15 years younger) to 15 (15 years older)).
Measured: Week 4
Descriptive summary of Global Aesthetic Improvement Scale (GAIS) scores for treated subjects at Week 4, as completed by the treating investigator.
This assessment is a measure of aesthetic improvement relative to the baseline, pre-treatment condition, as assessed from photographs.
The Investigator-GAIS is a 7-point scale ranging from -3 (very much worse) to +3 (very much improved).
Measured: Week 4
Descriptive summary of GAIS scores for treated subjects at Week 4, as completed by the subject.
This assessment is a measure of aesthetic improvement relative to the baseline, pre-treatment condition, as assessed from photographs.
The Investigator-GAIS is a 7-point scale ranging from -3 (very much worse) to +3 (very much improved).
Measured: Week 4
Evaluate the incidence and nature of device- and/or injection-related AEs, and SAEs observed during the study.
Measured: Week 4
Common treatment site responses (CTRs) will be evaluated using subject diaries
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 posted26 Oct 2017
- Study start29 Sep 2017
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Midface Volume DeficitStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Scientific Expert, Study director, Merz Pharmaceuticals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321825
- Sponsor's protocol ID
- M930071002
- Status last verified
- Jan 2018
- First submitted
- 4 Oct 2017
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Merz Cheek Fullness Assessment Scale in the Treatment of Midface Volume Deficit
- ClinicalTrials.gov ID
- NCT03321825
- Acronym / sponsor ID
- M930071002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the sensitivity of the Merz Cheeks Fullness Assessment Scale (MCFAS) and the clinical relevance of aesthetically pleasing outcomes by detecting changes in cheek appearance after Belotero® Volume Lidocaine injection.
The safety objectives include the identification and description of adverse events (AEs), adverse device effects (ADEs), serious adverse events (SAEs), serious adverse device effects (SADEs), anticipated serious adverse device effects (ASADEs) and unanticipated adverse device effects (UADEs) during the course of the study. Additionally, common treatment site responses (CTRs) will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belotero® Volume Lidocaine | Experimental | Device: Belotero® Volume LidocaineSubdermal injection |
| No treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Has right and left cheek volume deficit with a rating of 2 or 3 (moderately or severely sunken cheeks) on the MCFAS as determined by the blinded evaluator.
- 2. Has the same MCFAS score on both cheeks (i.e., cheeks are symmetrical).
- 3. Is at least 18 years of age.
- 4. Understands and accepts the obligation not to receive any other procedures (i.e., dermal fillers, toxin treatments, facial ablative or fractional laser, microderm abrasion, chemical peels, non-invasive skin-tightening [e.g., Ultherapy, Thermage] and/or surgical procedures) in the face during participation in the study.
Key exclusion criteria (12 listed)
- 1. Skin atrophy in the midfacial region other than that related to age.
- 2. Has gained or lost and ≥ 2 body mass index (BMI) units within the previous 90 days or has the intention to gain or lose a significant amount of weight during the course of the study.
- 3. Unphysiological skin laxity and/or sun damage beyond typical for the subject's age or subject plans to tan during the study period.
- 4. Acute inflammatory process or infection at the injection site (e.g., acne, eczema, streptococcus infections), or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of AEs.
- 5. Prior surgery, including midfacial plastic surgery, or has a permanent implant or graft in the midfacial region that could interfere with effectiveness assessments.
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 |
|---|---|---|
| Belotero® Volume LidocaineAlso: Hyaluronic acid dermal filler containing 0.3% of lidocaine hydrochloridMode of application: subdermal injection | Device | Belotero® Volume Lidocaine |
Primary outcome
Comparison of the responder rate between the treatment group and the untreated control group at Week 4, according to the Merz Cheeks Fullness Assessment Scale (MCFAS) as assessed by a blinded evaluator.
Time frame: Week 4
Treatment response is defined as ≥ 1-point improvement on both cheeks compared to baseline. The MCFAS is a 5-point ordinal rating scale ranging from 0 (full cheek) to 5 (very severely sunken cheek).
6 secondary outcomes
Descriptive summary of the FACE-Q satisfaction of the midface for treated subjects at baseline and Week 4
Time frame: Week 4
Average percent change of the FACE-Q satisfaction of the midface for treated subjects from baseline to Week 4
Time frame: Week 4
Descriptive summary of Global Aesthetic Improvement Scale (GAIS) scores for treated subjects at Week 4, as completed by the treating investigator.
Time frame: Week 4
Descriptive summary of GAIS scores for treated subjects at Week 4, as completed by the subject.
Time frame: Week 4
Evaluate the incidence and nature of device- and/or injection-related AEs, and SAEs observed during the study.
Time frame: Week 4
Common treatment site responses (CTRs) will be evaluated using subject diaries
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Moderate to Severe Midface Volume Deficit
Not yet recruiting
Post-Approval Study of Saypha® ChIQ™ for Midface Augmentation in Subjects With Fitzpatrick Skin Types V and VI
Moderate to Severe Midface Volume Deficit
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 Scientific Expert study director
Merz Pharmaceuticals GmbH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Belotero® Volume Lidocaine in people with Moderate to Severe Midface Volume Deficit, run by Merz North America, Inc. at 3 sites in Canada.
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 12 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 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of the responder rate between the treatment group and the untreated control group at Week 4, according to the Merz Cheeks Fullness Assessment Scale (MCFAS) as assessed by a blinded evaluator. (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 19 Jan 2018.