Efficacy and Performance Evaluation of mIntense L+AS 25 mg/ml Hyaluronic Acid for the Correction … (NCT06451822) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Performance Evaluation of mIntense L+AS 25 mg/ml Hyaluronic Acid for the Correction of Moderate to Deep Wrinkles and Folds
Bulgaria42 participantsStarted 2022-02-03
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 mIntense L+AS in the treatment of small skin defects, such as wrinkles or scars. 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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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female subjects aged ≥18 and ≤70 years;
* Subjects showing signs of facial skin depressions, scars or deep wrinkles;
* Aesthetic scores of 3 or 4 (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;
* 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…
What they're measuring
1
Frequency and severity of AEs, SAEs, ISRs, TEAEs
Timeframe: Two months after the first treatment (Session 3 (Day 60))