Predictive Algorithm for Product Selection in the Management of Mid Facial Volume Correction: Part I - A Pilot Validation of Patient Strata
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Erevna Innovations Inc.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Comparison of two Restylane products to treat mid-face/cheek deformities.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
- •Patients with a tendency to form hypertrophic scars or any other healing disorders;
- •Patients with known hypersensitivity to lidocaine or agents structurally related to amide type local anaesthetics (e.g., certain anti-arrhythmics);
- •Patients administered dental block or topical administration of lidocaine;
- •Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
- •Skin thickness between 1.2mm and 1.49mm (as determined by ultrasound).
Arms & Interventions
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.
Intervention: Restylane Lyft (Device)
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.
Intervention: Restylane Volyme (Device)
Outcomes
Primary Outcomes
Comparison of two Restylane products to treat mid-face/cheek deformities.
Time Frame: Baseline and Week 16.
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.
Secondary Outcomes
- 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)
- Standardized Imagery for the Improvement of Mid-face Hollowing(Baseline to week 8)