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Soft tissue filler injections continue to grow in popularity as a method of facial rejuvenation, including volume restoration and contour enhancement.
Many different hyaluronic acid (HA)-based fillers are available on the market and differ in terms of their physical and chemical properties, which results in families of fillers (e.g., Non-Animal Stabilized Hyaluronic Acid - NASHA vs. Optimal Balance Technology - OBT) with different tissue integration patterns. It has been proposed that the properties of fillers significantly influences their tendency to migrate. More specifically, thick fillers may be less prone to migration compared to fluid fillers. However, a detailed knowledge of facial anatomy, safer injection techniques, and careful product selection based on filler qualities may be preventive measures for filler migration.
The goal of this study is to describe the short and intermediate-term product distribution/integration patterns of NASHA and OBT-based fillers, and to evaluate the evidence (if any) of filler migration from the intended site of injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Injectables | Other | All adult participants (>18 years) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Injectables | Device | Participants will receive pan-facial treatment in at least one facial area using a Restylane NASHA product and at least one different facial area using Restylane OBT product. Participants will undergo three (3) scheduled MRI scans thoughout the duration of the study post HA injections. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate evidence (if any) of filler migration from the intended site of injection for NASHA and OBT-based fillers, as visualized by high resolution MRI. | High resolution MRI will determine presence of filler migration. Migration will be assessed radiologically and defined as the presence of identifiable product in anatomical regions outside the treatment area (where the product was initially placed) using a dichotomous qualitative response "yes/no". | Baseline (post optimal correction), Week 12 and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of particpants assessed as having proudct distribution past the area of injection. Assesment will be determined clincially by a qualified physician. | Physician evaluation will determine the distribution/integration patterns of NASHA and OBT-based fillers through palpable assessment in whcih the physician will use a binary "yes" or "no" responde to denote filler migration from the area of original placemement. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the frequncy of advese events (safety) of pan-facial HA injections. | Adverse events (safety) realted to pan-facial injections using NASHA and OBT based products will be determined by the frequency and severity of Adverse Events (AEs):
| Baseline to Week 24 |
Inclusion Criteria:
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, HA filler or amide local anesthetics;
Participants presenting with porphyria or any other liver diseases;
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, since drug allergies might preclude optimal management of complications;
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 facial surgery, including liposuction;
Lifetime history of permanent implants in the treatment region;
History in the last 18 months of semi-permanent dermal fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation in the treatment region;
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;
Participant has an uncontrolled systemic diseases
Participants present with or have a history of any medical condition that may place the participant at increased risk following exposure to hyaluronic acid or interfere with the study evaluation, including:
Facial psoriasis, eczema, acne, rosacea, perioral dermatitis, herpes zoster or any other facial condition that may increase the risk of cutaneous penetration of infective agents;
Scars, deformities, piercing, or tattoos in the treatment areas;
Facial 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;
Participants with active immune disorders such as systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease, and Hashimoto's thyroiditis, or participants using immunosuppressants;
Participants with a tendency to form hypertrophic or keloid scars, or any other healing disorders;
Participants with known hypersensitivity to lidocaine or agents structurally related to amide type local anaesthetics (e.g., certain anti-arrhythmics);
Participants administered dental block or topical administration of lidocaine within 2 weeks of treatment;
Participants with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction;
Current remote infections (e.g., urinary tract, sinuses, intestinal tract, oral cavity);
Planned dental procedures during the 2-week period before and after filler treatments, including teeth cleaning, tooth extraction and gum grafts.
Planned COVID-19 vaccinations during the 2-week period before and after filler treatments.
History of cystic acne (for those that will be treated in the chin region).
Female participants that is pregnant or breastfeeding and is considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study medical device or until the end of study, whichever is longer
Anticipated need for surgery or hospitalization during the course of the study
History of other treatment/procedure that, in the treating investigator's opinion, would interfere with the study injections and/or study assessments or exposes the participant to undue risk by study participation.
Contraindications for Magnetic Resonance Imaging (MRI) such as:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Nikolis, MD | Erevan Innovations Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erevna Innovations Inc. | Westmount | Quebec | H3Z 1C3 | Canada |
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|
| Baseline (post optimal correction), Week 12 and Week 24 |
| Number of particpants assessed as having proudct distribution past the area of injection. Assesment will be made uisng ultrasoundimaging | Ultrasound evaluation will determine the distribution/integration patterns of NASHA and OBT-based fillers through visual changes to position of filler deposition. | Baseline (post optimal correction), Week 12 and Week 24 |