Clinical Investigation to Assess Safety and Performance of Dermal Filler of Hyaluronic Acid (NCT05450380) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation to Assess Safety and Performance of Dermal Filler of Hyaluronic Acid
Spain50 participantsStarted 2022-08-02
Plain-language 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.
Who can participate
Age range45 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Evaluation of occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) of device LIFT001 at 2 months time
Timeframe: 2 MONTHS
2
Performance of device LIFT001 at 2 months time - GAIS scale
Timeframe: 2 MONTHS
3
Performance of device LIFT001 at 2 months time - WSRS scale
Timeframe: 2 MONTHS
4
Performance of device LIFT001 at 2 months time - 2D images