Midfacial Product Selection

NCT ID: NCT03381040

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-05
• Study Completion Date: 2019-01-08

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)?

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.

Conditions

Facial Volume Loss

Study Design

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

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Restylane Lyft

Intervention Type: 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 B

Poor structural support/volume (atrophy of soft tissues, leading to loss of projection) with poor skin envelope (thin skin). Treated with Restylane Volyme.

Group Type: ACTIVE_COMPARATOR

Restylane Volyme

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Erevna Innovations Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Nikolis, MD

Role: PRINCIPAL_INVESTIGATOR

Erevna Innovations Inc.

Locations

Victoria Park Clinical Research Centre

Westmount, Quebec, Canada

Countries

Canada

Other Identifiers

2017-01-001G

Identifier Type: -

Identifier Source: org_study_id