Evaluation of the Safety and Performance Characteristics of Mesofiller Mesotox for the Correction of Wrinkles and Rehydration of the Face.

NCT06477432 | Completed

• 1 other identifier: MSmesotox-022
• Study Type: interventional
• Target: 52
• 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 the evaluation of the safety and performance of the product mesofiller® mesotox 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)

• Lemperle's Scale - principal investigator evaluation

  Session 1 (Day 1); Session 2 (Day 14); Session 3 (Day 60); and Session 4 (Day 180).

• Glogau class - principal investigator evaluation

  Session 1 (Day 1); Session 2 (Day 14); Session 3 (Day 60); and Session 4 (Day 180) .

• Wrinkle Severity Rating Scale (WSRS) - principal investigator evaluation

  Session 1 (Day 1); Session 2 (Day 14); Session 3 (Day 60); and Session 4 (Day 180).

• Wrinkle Severity Rating Scale (WSRS) - patient evaluation

  Session 1 (Day 1); Session 2 (Day 14); Session 3 (Day 60); and Session 4 (Day 180).

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

  Session 1; Session 2 (Day 14); Session 3 (Day 60); and Session 4 (Day 180).

Study Arms (1)

mesofiller® mesotox

EXPERIMENTAL

The investigated product mesofiller® mesotox 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. Both sessions were conducted within 14-day intervals.

Device: mesofiller® mesotox

Interventions

mesofiller® mesotox DEVICE

The investigated product mesofiller® mesotox 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. Both sessions were conducted within 14-day intervals.

mesofiller® mesotox

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 subject aged ≥20 and ≤70 years;
• Subject presenting signs of skin depressions, scars or wrinkles in the upper part of the face;
• Subject is classified with grades 1 or 2 with the Lemperle scale in at least one of the following regions: "horizontal forehead lines", "glabellar frowns", and/or "periorbital lines";
• Subject is classified with grades 1 or 2 wrinkles with the Glogau scale;
• 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;

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, acetyl hexapeptide-8) or other anesthetics or nerve-blocking agents, or significant allergy or hypersensitivity to food and drugs;
• Subject is classified with grades 3 or 4 with the Lemperle scale in any of the following regions: "horizontal forehead lines", "glabellar frowns", and/or "periorbital lines";
• 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 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 investigations 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;

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

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 27, 2024
• Study Start: November 15, 2022
• Primary Completion: July 5, 2023
• Study Completion: July 5, 2023
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)