Status:
COMPLETED
Midfacial Product Selection
Lead Sponsor:
Erevna Innovations Inc.
Conditions:
Facial Volume Loss
Eligibility:
FEMALE
30-75 years
Phase:
PHASE4
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 envelo...
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 Res...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03381040
Start Date
December 5 2017
End Date
January 8 2019
Last Update
January 10 2019
Active Locations (1)
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1
Victoria Park Clinical Research Centre
Westmount, Quebec, Canada, H3Z1C3