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

NCT ID: NCT03321825

Last Updated: 2018-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-29
• Study Completion Date: 2018-01-08

Brief 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.

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.

Conditions

Moderate to Severe Midface Volume Deficit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Belotero® Volume Lidocaine

Subdermal injection

Group Type: EXPERIMENTAL

Belotero® Volume Lidocaine

Intervention Type: DEVICE

Mode of application: subdermal injection

No treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Belotero® Volume Lidocaine

Mode of application: subdermal injection

Intervention Type: DEVICE

Other Intervention Names

Hyaluronic acid dermal filler containing 0.3% of lidocaine hydrochlorid

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merz North America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Merz Scientific Expert

Role: STUDY_DIRECTOR

Merz Pharmaceuticals GmbH

Locations

Institute of Cosmetic and Laser Surgery; Merz Inverstigational Site #0010409

Oakville, Ontario, Canada

Research Toronto; Merz Investigational Site #0010408

Toronto, Ontario, Canada

Cosmetic Dermatology Toronto Yorkville; Merz Investigational Site #'0010412

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

M930071002

Identifier Type: -

Identifier Source: org_study_id