Efficacy and Performance Evaluation of mIntense L+AS 25 mg/ml Hyaluronic Acid for the Correction of Moderate to Deep Wrinkles and Folds (M-INT-LS)

An Open-label Uncontrolled Single Centre Investigation for the Evaluation of the Safety and Performance Characteristics of the Dermal Filler mIntense L+AS, Hyaluronic Acid 25 mg/ml (M-INT-LS) for Soft Tissue Augmentation to Correction of Moderate to Deep Wrinkles and Folds

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.

Study Overview

• Status: Completed
• Conditions: Skin Aging; Skin Wrinkling
• Intervention / Treatment: Device: mIntense L+AS

Detailed Description

The product mIntense L+AS is a dermal filler manufactured by mesoestetic Pharma Group s.l. It was intended to be used as a temporary filler to correct small skin defects, such as wrinkles or scars. In particular, it was recommended for the treatment of deep wrinkles.

mIntense L+AS for the facial area is a sterile, injectable, gel colourless, transparent, non-pyrogenic, reabsorbable product containing cross-linked hyaluronic acid of non-animal origin, produced via bacterial fermentation.

This clinical investigation was conducted as an uncontrolled - no comparator was used. The safety and performance of the treatment were evaluated by comparison of the condition with the state of the treated area before initiation of the procedure, conducted by the trained Principal Investigator.

The investigated product mIntense L+AS 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.

The evaluation process during the medical examination was facilitated by photographic evidence taken before and after therapy at predetermined time points for reference.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1000
    • "Medical Center Ramus" EOOD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 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 Criteria:

• Subject with known serious multiple allergies, sensitivity to any of the active ingredients (hyaluronic acid, lidocaine) 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 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);
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mIntense L+AS; The investigated product mIntense L+AS 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: mIntense L+AS; The investigated dermal filler mIntense L+AS is intended to be used as a temporary filler, administered by intradermal or subcutaneous injections, to correct small skin defects, such as wrinkles or scars.; Other Names: M-INT-LS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and severity of AEs, SAEs, ISRs, TEAEs	The safety evaluation of mIntense L+AS will also rely on participants' complaints, physical examination of BP, HR, body temperature	Two months after the first treatment (Session 3 (Day 60))

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrinkle Severity Rating Scale (WSRS) - principal investigator evaluation	The absolute change in the Wrinkle Severity Rating Scale from baseline, evaluated by the PI based on photographs of the treated area. The scale ranges from grade 1 to 5, with grade 1 representing the best possible outcome.	Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Wrinkle Severity Rating Scale (WSRS) - patient evaluation	The absolute change in the Wrinkle Severity Rating Scale from baseline, evaluated by the patient. The scale ranges from grade 1 to 5, with grade 1 representing the best possible outcome.	Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Global Aesthetic Improvement Scale (GAIS) - principal investigator evaluation	Improvement in the Global Aesthetic Improvement Scale as evaluated by the PI based on the photographs of the treated area. GAIS ranges from grade 1 to 5, where grade 1 shows exceptional improvement.	Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Global Aesthetic Improvement Scale (GAIS) - patient evaluation	Improvement in the Global Aesthetic Improvement Scale as evaluated by the patient. GAIS ranges from grade 1 to 5, where grade 1 shows exceptional improvement.	Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Visual Analogous Scale (VAS) - principal investigator evaluation	The absolute change in the Visual Analogous Scale from baseline judged by the PI. VAS ranges from grade 0 to 10, where grade 10 is the best possible outcome.	Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Visual Analogous Scale (VAS) - patient evaluation	The absolute change in the Visual Analogous Scale from baseline judged by the patient. VAS ranges from grade 0 to 10, where grade 10 is the best possible outcome.	Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Subject satisfaction	The Patient's Questionnaire was utilised. The satisfaction survey grades range from 1 to 3, where grade 1 represents the highest satisfaction level.	Sessions 1 (Day 1), 2 (Day 14), 3 (Day 60), 4 (Day 180), 5 (Day 270) and 6 (Day 365)
Frequency and severity of AEs, SAEs, ISRs, TEAEs	The safety evaluation of mIntense L+AS will also rely on participants' complaints, physical examination of BP, HR, body temperature	Sessions 1 (Day 1), 2 (Day 14), 3 (Day 60), 4 (Day 180), 5 (Day 270) and 6 (Day 365)

Collaborators and Investigators

• Sponsor: Mesoestetic Pharma Group S.L.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: M-INT-LS-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No