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

NCT05450380 | Completed

• 1 other identifier: CIP-LIFT001-042022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Skin Folds; Wrinkle

Outcome Measures

Primary Outcomes (4)

• Evaluation of occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) of device LIFT001 at 2 months time

  The primary endpoint is to assess the safety of product LIFT001 by occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) through 2 months post-treatment.

  2 MONTHS

• Performance of device LIFT001 at 2 months time - GAIS scale

  The performance of the device LIFT001 will also be assessed as the aesthetical outcome measured by: * Global Aesthetic Improvement Scale (GAIS) Score Grade Description 7 Very Much Improved Very marked improvement in appearance to 1 Very Much Worse The appearance is very much worse than the original condition

  2 MONTHS

• Performance of device LIFT001 at 2 months time - WSRS scale

  The performance of the device LIFT001 will also be assessed as the aesthetical outcome measured by: \- Wrinkle Severity Rating Scale (WSRS) Score Severity descriptions 4 Extreme Very deep wrinkle, redundant fold (overlapping skin) 0 None No wrinkle

  2 MONTHS

• Performance of device LIFT001 at 2 months time - 2D images

  The performance of the device LIFT001 will also be assessed as the aesthetical outcome measured by: \- 2D images of subjects' faces at 2 months post-treatment.

  2 MONTHS

Secondary Outcomes (4)

• Evaluation of occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) of device LIFT001 at 6, 9 and 12 months time

  12 MONTHS

• Performance of device LIFT001 at 12 months time - GAIS scale

  12 months

• Performance of device LIFT001 at 12 months time - WSRS scale

  12 months

• Performance of device LIFT001 at 12 months time - 2D images

  12 months

Study Arms (1)

Experimental: LIFT001

EXPERIMENTAL

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.

Device: LIFT001

Interventions

LIFT001 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.

Experimental: LIFT001

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject who had provided written informed consent form.
• Adult male or female subjects between 45 and 70 years old.
• 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.
• 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.

You may not qualify if:

• 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.
• Any disease at baseline that results in changes of facial contour or facial edema.
• Active skin disease or inflammation on or near the injection area at baseline that could interfere with the clinical investigation injections or assessments.
• History of connective tissue diseases.
• 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.
• Any aesthetic treatment/procedure on the face in the previous 6 months that may interfere with study injections and/or study assessments.
• Subjects who have received permanent facial implants within the previous 36 months.
• Presence of any condition, which in the opinion of the investigator, made the subject unable to complete the clinical investigation per protocol.
• Subjects who are currently participating in another clinical investigation which may interfere with this clinical investigation.
• Pregnant or nursing subjects, and subjects who plan pregnancy during the clinical investigation period.
• Subjects undergoing restrictive nutritional regimens.
• Subjects who practice facial impact sports, such as boxing, karate, taekwondo and other similar sports.

Sponsors & Collaborators

• Mesoestetic Pharma Group S.L.: lead

Study Sites (2)

Centro Dermatologico Internacional - Cdi

Madrid, CAM, 28001, Spain

Location

Hospital Ruber Internacional

Madrid, CAM, 28034, Spain

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 15, 2022
• First Posted: July 8, 2022
• Study Start: August 2, 2022
• Primary Completion: July 31, 2023
• Study Completion: January 31, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Locations

ES (2)