Evaluation of the Safety and Performance Characteristics of Mesofiller Aox for the Correction of Mild and Moderate Facial Wrinkles.

NCT06486740 | Completed

• 1 other identifier: M-AOX-2021
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Skin Aging; Skin Wrinkling

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of AEs, SAEs, ISRs, TEAEs

  Two months after the first treatment (Session 3 (Day 60))

Secondary Outcomes (8)

• Modified Fitzpatrick Wrinkle Scale (MFWS) - principal investigator evaluation.

  Session 1 (Day 1), Session 2 (Day 14), Session 4 (Day 180), Session 5 (Day 270), and Session 6 (Day 365).

• Modified Fitzpatrick Wrinkle Scale (MFWS) - patient evaluation.

  Session 1 (Day 1), Session 2 (Day 14), Session 4 (Day 180), Session 5 (Day 270), and Session 6 (Day 365).

• Global Aesthetic Improvement Scale (GAIS) - principal investigator evaluation.

  Session 2 (Day 14), Session 4 (Day 180), Session 5 (Day 270), and Session 6 (Day 365)

• Global Aesthetic Improvement Scale (GAIS) - patient evaluation.

  Session 2 (Day 14), Session 4 (Day 180), Session 5 (Day 270), and Session 6 (Day 365)

• Visual Analogous Scale (VAS) - principal investigator evaluation.

  Session 2 (Day 14), Session 4 (Day 180), Session 5 (Day 270), and Session 6 (Day 365)

Study Arms (1)

mesofiller aox

EXPERIMENTAL

The investigated product M-AOX-2021 was applied by intradermal or subcutaneous injection by the investigator during Session 1 for all subjects and Session 2 for the subjects, for whom a touch-up was considered beneficial. The both sessions was conducted within 14 days interval.

Device: mesofiller aox

Interventions

mesofiller aox DEVICE

The investigated product M-AOX-2021 was applied by intradermal or subcutaneous injection by the investigator during Session 1 for all subjects and Session 2 for the subjects, for whom a touch-up was considered beneficial. The both sessions was conducted within 14 days interval.

mesofiller aox

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Mesoestetic Pharma Group S.L.: lead

Study Sites (1)

"Medical Center Ramus" EOOD

Sofia, 1000, Bulgaria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 3, 2024
• Study Start: October 3, 2022
• Primary Completion: January 8, 2024
• Study Completion: January 8, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)