Clinical trial NCT03381040: Midfacial Product Selection
Official title: Predictive Algorithm for Product Selection in the Management of Mid Facial Volume Correction: Part I - A Pilot Validation of Patient Strata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Facial Volume Loss
Lead sponsor: Erevna Innovations Inc.
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Comparison of two Restylane products to treat mid-face/cheek deformities.
timeFrame: Baseline and Week 16.
Secondary outcomes:
measure: Standardized Imagery for the Improvement of Mid-face Hollowing
timeFrame: Baseline to week 8
measure: Patient satisfaction questionnaire
timeFrame: Baseline to 16 weeks
measure: Global aesthetic improvement scale
timeFrame: Baseline to 16 weeks
measure: Medicis Mid-face Volume Scale
timeFrame: Baseline to 16 weeks
measure: Standardized Ultrasonography Images
timeFrame: Baseline to 16 weeks
Other outcomes:
measure: Adverse events
timeFrame: Baseline to 16 weeks
Locations:
city: Westmount
country: Canada
facility: Victoria Park Clinical Research Centre
state: Quebec
Study officials:
affiliation: Erevna Innovations Inc.
name: Andreas Nikolis, MD
role: PRINCIPAL_INVESTIGATOR
References: