Wrinkles Such as Nasolabial Folds Clinical Trial
Official title:
A Prospective, Split-face, Randomized, Comparative Trial on the Efficacy of Two Hyaluronic Acid Products (Restylane + Lidocaine and Restylane Lyft) for the Treatment of Nasolabial Folds
Verified date | April 2020 |
Source | Erevna Innovations Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to assess and compare the efficacy of two hyaluronic acid (HA) fillers on moderate, severe and extreme nasolabial folds (NLF).
Status | Completed |
Enrollment | 10 |
Est. completion date | February 12, 2020 |
Est. primary completion date | December 12, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. At the time of consent, women between the ages of 30 and 75 years old; 2. Indication for treatment of bilateral NLFs and wrinkles; 3. Willingness to comply with study requirements; 4. Provide written consent; 5. Accepted the obligation not to receive any other facial procedures through the follow-up; 6. Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits; 7. No previous facial fillers for a period of 12 months prior to this study; 8. No previous facial fillers in the complete region of the NLF for 18 months prior to this study 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 hyaluronic acid or local anesthetics; 3. Patients meeting any official Restylane contra-indications; 4. Patients presenting with porphyria; 5. Inability to comply with follow-up and abstain from facial injections during the study period; 6. Heavy smokers, classified as smoking more than 12 cigarettes per day; 7. History of severe or multiple allergies manifested by anaphylaxis; 8. 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; 9. Previous maxillofacial surgery including aesthetic facial surgical therapy or liposuction, piercing, or tattoos in the treatment area; 10. 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; 11. Facial psoriasis, eczema, acne, rosacea, perioral dermatitis and herpes zoster in the treatment area; 12. Cancer or precancer in the treatment area, e.g. actinic keratosis; 13. 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; 14. Patients using immunosuppressants; 15. Patients with a tendency to form hypertrophic scars or any other healing disorders; 16. Patients with known hypersensitivity to lidocaine or agents structurally related to amide type local anaesthetics (e.g., certain anti-arrhythmics); 17. Patients administered dental block or topical administration of lidocaine; 18. Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction. |
Country | Name | City | State |
---|---|---|---|
Canada | Erevna Innovations Inc | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Erevna Innovations Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Skin lifting capacity of two Restylane products, as assessed by ultrasound | The lifting capacity of two Restylane products (i.e., Restylane + Lidocaine and Restylane Lyft) will be assessed post-injection, using a skin ultrasound. | Baseline | |
Secondary | Skin lifting capacity of two Restylane products, as assessed by ultrasouns | The lifting capacity of two Restylane products (i.e., Restylane + Lidocaine and Restylane Lyft) will be assessed post-injection, using a skin ultrasound. | Week 2 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05040594 -
Evaluate the Efficacy and Safety of Lidocaine-Containing Hyaluronic Acid Filler in the Treatment of Nasolabial Folds.
|
N/A |