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

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: Completed
• Conditions: Moderate to Severe Midface Volume Deficit
• Intervention / Treatment: Device: Belotero® Volume Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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.	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

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

Collaborators and Investigators

• Sponsor: Merz North America, Inc.
• Investigators: Study Director: Merz Scientific Expert, Merz Pharmaceuticals GmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2017
• Primary Completion (Actual): January 8, 2018
• Study Completion (Actual): January 8, 2018

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 26, 2017

Study Record Updates

• Last Update Posted (Actual): January 19, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Immunologic Factors; Protective Agents; Membrane Transport Modulators; Adjuvants, Immunologic; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Viscosupplements; Lidocaine; Hyaluronic Acid
• Other Study ID 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