Midfacial Product Selection

NCT03381040 | Completed Phase 4

• 1 other identifier: 2017-01-001G
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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)?

Conditions

Facial Volume Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Standardized Imagery for the Improvement of Mid-face Hollowing

  Baseline to week 8

• Patient satisfaction questionnaire

  Baseline to 16 weeks

• Global aesthetic improvement scale

  Baseline to 16 weeks

• Medicis Mid-face Volume Scale

  Baseline to 16 weeks

• Standardized Ultrasonography Images

  Baseline to 16 weeks

Other Outcomes (1)

• Adverse events

  Baseline to 16 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Group B

ACTIVE COMPARATOR

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

Interventions

Restylane Lyft DEVICE

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.

Group A

Restylane Volyme DEVICE

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.

Group B

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current Pregnancy or lactation \[sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)\].;
• Hypersensitivity to Restylane products, hyaluronic acid filler or amide local anesthetics;
• Patients presenting with porphyria;
• Inability to comply with follow-up and abstain from facial injections during the study period;
• Heavy smokers, classified as smoking more than 12 cigarettes per day;
• History of severe or multiple allergies manifested by anaphylaxis;
• 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;
• Previous surgery including aesthetic facial surgical therapy or liposuction, piercing, or tattoos in the treatment area;
• 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;
• Facial psoriasis, eczema, acne, rosacea, perioral dermatitis and herpes zoster;
• Scars or deformities;
• Cancer or precancer, e.g. actinic keratosis;
• History of radiation therapy to the treatment area;
• 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;
• Patients using immunosuppressants;

Sponsors & Collaborators

• Erevna Innovations Inc.: lead

Study Sites (1)

Victoria Park Clinical Research Centre

Westmount, Quebec, H3Z1C3, Canada

Location

Study Officials

• Andreas Nikolis, MD

  Erevna Innovations Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 21, 2017
• Study Start: December 5, 2017
• Primary Completion: August 15, 2018
• Study Completion: January 8, 2019
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)