Efficacy and Performance Evaluation of mGlobal L+AS 20 mg/ml Hyaluronic Acid, for the Correction … (NCT06482723) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Performance Evaluation of mGlobal L+AS 20 mg/ml Hyaluronic Acid, for the Correction of Light to Moderate Wrinkles and Folds
Bulgaria42 participantsStarted 2022-03-03
Plain-language summary
The investigation is a single-centre, interventional, prospective, non-randomized, open-label, uncontrolled, single-arm, un-blinded investigation for evaluation of the safety and performance of the product mGlobal L+AS for correction of small skin defects, such as wrinkles or scars, in particular for the treatment of wrinkles around the lips The clinical investigation is interventional and prospective in agreement with the pre-market regulatory status of the product.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 …
What they're measuring
1
Frequency and severity of AEs, SAEs, ISRs, TEAEs
Timeframe: Two months after the first treatment (Session 3 (Day 60))