Status:
COMPLETED
Evaluation of the Safety and Performance Characteristics of Mesofiller Aox for the Correction of Mild and Moderate Facial Wrinkles.
Lead Sponsor:
Mesoestetic Pharma Group S.L.
Conditions:
Skin Aging
Skin Wrinkling
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief 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 medica...
Detailed Description
The product M-AOX-2021 is a dermal filler manufactured by mesoestetic Pharma Group s.l.. It was intended to be used as a temporary dermal filler for dermatological treatment for aesthetic purposes. Th...
Eligibility Criteria
Inclusion
- 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:
- 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.
Exclusion
- Subject with known severe or multiple allergies, including allergy or hypersensitivity to any of the DF components (HA, lidocaine, succinic acid, ascorbyl glucoside, idebenone) or other anesthetics or nerve-blocking agents,or significant allergy or hypersensitivity to food and drugs;
- History of any disease resulting in changes of facial contour or oedema of the face during the clinical investigation period;
- Ascertained tendency to develop hypertrophic or keloid scars or pigmentation disorders;
- History of connective tissues diseases;
- History of active autoimmune diseases or those under immunotherapy;
- History of or laboratory results suggesting coagulation disorder;
- Active skin disease or inflammation of or near the injection area that could interfere with the clinical investigation injections or assessments;
- Subject who suffers from another medical condition or who is receiving medication that in the Principal Investigator's judgment would prohibit inclusion in this investigation;
- Soft tissue augmentation with bovine collagen (in the previous 6 months), with porcine or human collagen (in the previous 12 months), or with hyaluronic acid or hydroxyapatite (in the previous 18 months);
- Subject with permanent implants in the neck or face within the previous 36 months;
- Any aesthetic treatment/procedure of the face in the previous 6 months that may interfere with the investigation's injections and/or investigation assessments, as judged by the investigator;
- Presence of any condition, which in the opinion of the investigator, makes the subject unable to complete the clinical investigation as per this CIP;
- Subject who is currently participating in another clinical investigation which may interfere with this clinical investigation results or who had participated in another clinical investigation within 30 days prior to enrollment in this investigation;
- Pregnancy, postpartum period (6 months), lactation or post-lactation period (6 months) or woman who plans pregnancy during the investigation follow-up period;
- Absence of a reliable and effective method of contraception for subject with childbearing potential;
- Known abuse of drugs, alcohol or other substances;
- Subject with limited mental and consistent comprehension abilities; incapacitated subjects; sportsmen and individuals on strenuous physical loading; prisoners;
- Refusal to sign the Informed Consent Form by the adult participant.
Key Trial Info
Start Date :
October 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2024
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06486740
Start Date
October 3 2022
End Date
January 8 2024
Last Update
July 3 2024
Active Locations (1)
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1
"Medical Center Ramus" EOOD
Sofia, Bulgaria, 1000