Efficacy and Performance Evaluation of mGlobal L+AS 20 mg/ml Hyaluronic Acid, for the Correction of Light to Moderate Wrinkles and Folds

Inclusion Criteria

• •Male or female subjects aged ≥18 and ≤70 years;
• •Subjects showing signs of skin depressions, scars or wrinkles around the lips;
• •Aesthetic scores of 2 or 3 (mild or moderate loss of midface fullness, respectively) on each side of the face assessed at baseline by the investigator;
• •Subject who is willing to abstain from any other facial aesthetic or cosmetic procedure or plastic surgery during the clinical investigation, including follow-up period;
• •Subject who understands and is willing to comply with all investigation-related activities and who is available for the duration of their participation in the investigation, including follow-up;
• •Absence of a history of significant hypersensitivity to food and drugs or known sensitivity to hyaluronic acid, lidocaine or other anesthetics or nerve-blocking agents;
• •Arterial blood pressure (BP) (after 5 min. at rest in the supine position) in reference range - systolic 90 - 140 mmHg and diastolic 50 - 90 mmHg;
• •Heart rate (HR) (after 5 min. at rest in the supine position) in reference range - over 50 beats/min and less than 100 beats/min;
• •Axillar body temperature of up to 37°С;
• •Clinical-laboratory examinations within the reference ranges or with no clinically significant abnormalities for CBC, ESR, PT/INR;
• •Negative pregnancy test for the women with reproductive potential;
• •Reliable and acceptable method of contraception for the women of child-bearing potential:
• •* IUD, inserted at least 3 months prior to the investigation initiation;
• •* Double barrier method (condom, spermicide-containing diaphragm) applied at least 14 days prior to the first investigated product application and throughout the course of the investigation;
• •* Hormonal contraception with use initiation at least 3 months prior to the first investigated product application and throughout the course of the investigation;
• •* Sexual abstinence for at least 14 days prior to enrollment into the investigation and throughout the course of the investigation;
• •* Surgical sterilisation (bilateral ligation of the uterine tubes, hysterectomy, bilateral ovariectomy or vasectomy of the regular partner) with no less than a 6-month history;
• •* Menopause with no less than a 2-year history prior to the investigation initiation.
• •Signed written Informed Consent Form by the adult participant.