Midfacial Product Selection

Predictive Algorithm for Product Selection in the Management of Mid Facial Volume Correction: Part I - A Pilot Validation of Patient Strata

This study seeks to determine whether patients pursuing injectable treatments for facial volume loss and/or contour deficiency can be separated into strata based on characteristics such as skin envelope and subcutaneous tissue quantity in the zygomatic, submalar and anteromedial cheek regions in order to guide the clinician in making the ideal product choice (i.e., Restylane Volyme vs Lyft)?

Study Overview

• Status: Completed
• Conditions: Facial Volume Loss
• Intervention / Treatment: Device: Restylane Lyft; Device: Restylane Volyme

Detailed Description

With age, loss of facial fat and hollowing of the cheeks can result in a "sinking" appearance in the mid-face. Augmentation and contouring of the area can be corrected using dermal fillers such as Restylane.

Currently, product choice and amount of volume used for injectable procedures varies between physicians as there is no standard for treatment. Individual assessment based on the attending physician's preference and experience determines final product selection and technique. An algorithm is needed to standardize best practices between physicians and clinics and to better regulate the use of dermal fillers in facial plastic surgery.

Therefore, the purpose of this study is to is to develop an algorithm to decide on which product (i.e., Restylane Volyme or Lyft) to use in the cheek area based on subject characteristics such as age, skin quality, subcutaneous fat quantity and positioning, and bony structure.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Westmount, Quebec, Canada, H3Z1C3
      • Victoria Park Clinical Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. At the time of consent, women between the ages of 30 and 75 years old;
2. Patients with established mid-face/cheek hollowing;
3. Patients with a MMVS score of 2 or 3 at baseline;
4. Accepted the obligation not to receive any other facial procedures through the 4-month follow-up;
5. Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
6. No previous facial fillers for a period of 12 months prior to this study;
7. No previous facial fillers in the mid-face for 18 months prior to this study;
8. Capable of providing informed consent.

Exclusion Criteria:

1. Current Pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)].;
2. Hypersensitivity to Restylane products, hyaluronic acid filler or amide local anesthetics;
3. Patients presenting with porphyria;
4. Inability to comply with follow-up and abstain from facial injections during the study period;
5. Heavy smokers, classified as smoking more than 12 cigarettes per day;
6. History of severe or multiple allergies manifested by anaphylaxis;
7. Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;
8. Previous surgery including aesthetic facial surgical therapy or liposuction, piercing, or tattoos in the treatment area;
9. History or presence of any disease or lesion near or at the treatment area, including inflammation, active or chronic infection, including in the mouth, dentals, head and neck region;
10. Facial psoriasis, eczema, acne, rosacea, perioral dermatitis and herpes zoster;
11. Scars or deformities;
12. Cancer or precancer, e.g. actinic keratosis;
13. History of radiation therapy to the treatment area;
14. History of bleeding disorders or treatment with thrombolytics, anticoagulants, or inhibitors of platelet aggregation (e.g. Aspirin or other non-steroid anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment;
15. Patients using immunosuppressants;
16. Patients with a tendency to form hypertrophic scars or any other healing disorders;
17. Patients with known hypersensitivity to lidocaine or agents structurally related to amide type local anaesthetics (e.g., certain anti-arrhythmics);
18. Patients administered dental block or topical administration of lidocaine;
19. Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
20. Skin thickness between 1.2mm and 1.49mm (as determined by ultrasound).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Poor structural support/volume (atrophy of soft tissues, leading to loss of projection) with adequate skin envelope (normal or thick skin). Treated with Restylane Lyft.	Device: Restylane Lyft; Restylane® Lyft is a sterile gel of hyaluronic acid with lidocaine generated by Streptococcus species of bacteria, chemically cross-linked with BDDE (the cross linker), stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL. Lyft is intended to be used for facial tissue augmentation. It is recommended that the product be used for shaping the contours of the face and the correction of folds using the co-packed needles. Given the very high lift capacity of Lyft, it is often used when the skin envelope is normal or thicker than normal, as the contours of the product may be palpable in the presence of thin skin.
Active Comparator: Group B; Poor structural support/volume (atrophy of soft tissues, leading to loss of projection) with poor skin envelope (thin skin). Treated with Restylane Volyme.	Device: Restylane Volyme; Restylane® Volyme is a sterile, biodegradable, viscoelastic, non-pyrogenic, clear, colorless, and homogeneous soft hyaluronic acid gel with a high lifting capacity. Volyme is intended for injection into the supraperiostic zone or subcutis to augment the volume of the cheeks. Given Volyme's viscoelastic and lifting capacities, it is best used when there is significant loss of volume and a thin skin envelope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of two Restylane products to treat mid-face/cheek deformities.	Investigators will evaluate whether a difference in physician assessed efficacy as per the standardized photos between two Restylane products at 16 weeks (visit 5) in comparison to baseline (visit 1) using the GAIS scale.	Baseline and Week 16.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized Imagery for the Improvement of Mid-face Hollowing	Investigators will evaluate whether an aesthetic change in mid-face contour is observed at visit 3 (4 weeks), and visit 4 (8 weeks) compared to Baseline. The change in mid-face shape will be assessed using the standardized photographs.	Baseline to week 8
Patient satisfaction questionnaire	Patients will rate their overall satisfaction with treatment results using the patient satisfaction questionnaire at visits 2, 3, 4 and 5. The questionnaire is a 5-point scale comprising 'extremely satisfied', 'satisfied', 'slightly satisfied', 'dissatisfied', and 'extremely satisfied'.	Baseline to 16 weeks
Global aesthetic improvement scale	Physicians will rate the overall improvement since injection using the Global Aesthetic Improvement Scale at visits 2, 3, 4 and 5. The scale is a 5-point scale comprising 'very much improved', 'much improved', 'improved', 'no change', and 'worse'.	Baseline to 16 weeks
Medicis Mid-face Volume Scale	At visits 2, 3, 4 and 5, a blinded reviewer will rate each patient's hemiface using the MMVS. The MMVS is a four-point scale that measures the amount of mid-face volume loss comprising of "fairly full", "mild loss", "moderate loss" and "substantial loss". MMVS response rate, defined as the percentage of subjects with at least a 1-grade improvement in MMVS from Baseline up to Week 16 after treatment, will be used in the analyses.	Baseline to 16 weeks
Standardized Ultrasonography Images	Ultrasound images will be taken before and after injections at the Baseline visit, and all subsequent follow up visits. At Visit 1, the images will be used to determine skin thickness and ascertain the site (e.g., dermis, subcutaneous region) of filler injected into the soft tissue of the face. At follow up visits, ultrasound images will be used to delineate whether the amount of filler has decreased between visits. The analyses of the sonographic characteristics of the fillers will allow for optimization of treatment results.	Baseline to 16 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events	Baseline to 16 weeks

Collaborators and Investigators

• Sponsor: Erevna Innovations Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2017
• Primary Completion (Actual): August 15, 2018
• Study Completion (Actual): January 8, 2019

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 21, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 2017-01-001G

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