Evaluation of the Safety and Performance Characteristics of Mesofiller Aox for the Correction of … (NCT06486740) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Safety and Performance Characteristics of Mesofiller Aox for the Correction of Mild and Moderate Facial Wrinkles.
Bulgaria55 participantsStarted 2022-10-03
Plain-language summary
The investigation is a single centre, interventional, prospective, non-randomized, open-label, uncontrolled, single arm, un-blinded investigation for evaluation of safety and performance of the medical device M-AOX-2021 in the treatment of wrinkles and imperfections. The clinical investigation is interventional and prospective in agreement with the pre-market regulatory status of the product.
Who can participate
Age range20 Years – 70 Years
SexALL
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Inclusion Criteria:
* Male or female subjects aged ≥20 and ≤70 years;
* Subjects presenting signs of skin depressions, scars or wrinkles in the lower two thirds of the face;
* Aesthetic scores of 2, 3 or 4 (mild, moderate or substantial 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…
What they're measuring
1
Frequency and severity of AEs, SAEs, ISRs, TEAEs
Timeframe: Two months after the first treatment (Session 3 (Day 60))