Clinical Investigation to Assess Safety and Performance of Dermal Filler of Hyaluronic Acid

NCT ID: NCT05450380

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2024-01-31

Brief Summary

The objective of this clinical investigation is to assess the safety and performance of dermal filler of hyaluronic acid to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections in the lower two thirds of the face at 2 months post-treatment.

Detailed Description

The primary endpoint is to assess the safety of dermal filler of hyaluronic acid by occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) through 2 months post-treatment. Furthermore, the performance of the device will also be assessed as the aesthetical outcome measured by the Global Aesthetic Improvement Scale (GAIS), Wrinkle Severity Rating Scale (WSRS), and 2D images of subjects' faces at 2 months post-treatment.The secondary endpoints are the following:

Secondary Safety Endpoint

• To assess the safety of dermal filler of hyaluronic acid by occurrence of Treatment-related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) through 6-, 9-, and 12-months post-treatment.
• To assess the safety of dermal filler of hyaluronic acid by occurrence of all AEs through 2-, 6-, 9-, and 12-months post-treatment.

Secondary Performance Endpoint

• To evaluate the performance of dermal filler of hyaluronic acid at 6-, 9- and 12-months post-treatment, assessed as the aesthetical outcome measured by the Global Aesthetic Improvement Scale (GAIS)
• Assessment of dermal filler of hyaluronic acid performance of mesofiller® Lift at 6-, 9- and 12-months post-treatment using the Wrinkle Severity Rating Scale (WSRS)
• Assessment of dermal filler of hyaluronic acid performance of dermal filler of hyaluronic acid at 6-, 9- and 12-months post-treatment using 2D images of subjects' faces
• Assessment of dermal filler of hyaluronic acid performance of dermal filler of hyaluronic acidt at 6-, 9- and 12-months post-treatment through satisfaction surveys related to the subject's appearance.

Conditions

Skin Folds; Wrinkle

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: LIFT001

LIFT001 is composed by sodium hyaluronate at concentration of 2,5% (25 mg/ml) with 1,4-Butanediol diglycidyl ether (BDDE) acting as a cross-linking agent, in aqueous solution at physiological pH. The filler of 1ml is administered once or twice depending on the individual necessity.

The dermal filler of hyaluronic acid LIFT001 is applied to the facial area to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections of face.

Group Type: EXPERIMENTAL

LIFT001

Intervention Type: DEVICE

The dermal filler of hyaluronic acid LIFT001 is applied to the facial area to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections of face.

The dermal filler of hyaluronic acid LIFT001 is applied to the facial area to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections of face.

Interventions

LIFT001

The dermal filler of hyaluronic acid LIFT001 is applied to the facial area to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections of face.

The dermal filler of hyaluronic acid LIFT001 is applied to the facial area to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections of face.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject who had provided written informed consent form.

2. Adult male or female subjects between 45 and 70 years old.

3. Subject with moderate (2) or higher score in the Wrinkle Severity Rating Scale (WSRS) in the lower two thirds, and in at least one of the two sides of the face, assessed at baseline by the treating investigator.

4. Subject must be willing to abstain from any other facial invasive treatment (plastic surgery, implants, peelings) in the lower two thirds of the face during the clinical investigation period.

Exclusion Criteria

1. History of severe or multiple allergies, including allergy or hypersensitivity to injectable hyaluronic acid gel, lidocaine, anesthetics, or nerve-blocking agents or any of the components of product.

2. Any disease at baseline that results in changes of facial contour or facial edema.

3. Active skin disease or inflammation on or near the injection area at baseline that could interfere with the clinical investigation injections or assessments.

4. History of connective tissue diseases.

5. Soft tissue augmentation in the previous 6 months with bovine collagen, in the previous 12 months with porcine or human collagen, or in the previous 18 months with hyaluronic acid or hydroxyapatite.

6. Any aesthetic treatment/procedure on the face in the previous 6 months that may interfere with study injections and/or study assessments.

7. Subjects who have received permanent facial implants within the previous 36 months.

8. Presence of any condition, which in the opinion of the investigator, made the subject unable to complete the clinical investigation per protocol.

9. Subjects who are currently participating in another clinical investigation which may interfere with this clinical investigation.

10. Pregnant or nursing subjects, and subjects who plan pregnancy during the clinical investigation period.

11. Subjects undergoing restrictive nutritional regimens.

12. Subjects who practice facial impact sports, such as boxing, karate, taekwondo and other similar sports.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mesoestetic Pharma Group S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro Dermatologico Internacional - Cdi

Madrid, CAM, Spain

Hospital Ruber Internacional

Madrid, CAM, Spain

Countries

Spain

Other Identifiers

CIP-LIFT001-042022

Identifier Type: -

Identifier Source: org_study_id