Evaluation of the Merz Cheek Fullness Assessment Scale in the Treatment of Midface Volume Deficit

January 18, 2018 updated by: Merz North America, Inc.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Oakville, Ontario, Canada, L6J 7W5
        • Institute of Cosmetic and Laser Surgery; Merz Inverstigational Site #0010409
      • Toronto, Ontario, Canada, M4W 2N2
        • Research Toronto; Merz Investigational Site #0010408
      • Toronto, Ontario, Canada, M5R 3N8
        • Cosmetic Dermatology Toronto Yorkville; Merz Investigational Site #'0010412

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: No treatment
Experimental: Belotero® Volume Lidocaine
Subdermal injection
Device: Belotero® Volume Lidocaine
Mode of application: subdermal injection
Other Names:
  • Hyaluronic acid dermal filler containing 0.3% of lidocaine hydrochlorid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Descriptive summary of the FACE-Q satisfaction of the midface for treated subjects at baseline and Week 4
Time Frame: 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)).
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
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)).
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

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).
Week 4
Descriptive summary of GAIS scores for treated subjects at Week 4, as completed by the subject.
Time Frame: Week 4

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).
Week 4
Evaluate the incidence and nature of device- and/or injection-related AEs, and SAEs observed during the study.
Time Frame: Week 4
Week 4
Common treatment site responses (CTRs) will be evaluated using subject diaries
Time Frame: Week 4
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merz North America, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Merz Scientific Expert, Merz Pharmaceuticals GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 8, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 8, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M930071002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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