NCT04645576

Evaluation of the Efficacy and Safety of an Injectable Hyaluronic Acid-based Filler, Art Filler® Volume: Comparative Single-blind Study of the Non-inferiority Versus Juvéderm® Voluma on the Midface, Temple and Jaw-line and Non-comparative Study on the Chin. (AF3)

Evaluation of the Efficacy and Safety of an Injectable Hyaluronic Acid-based Filler, Art Filler® Volume: Comparative Single-blind Study of the Non-inferiority Versus Juvéderm® Voluma on the Midface, Temple and Jaw-line and Non-comparative Study on the Chin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Laboratoires FILLMED · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume. These fillers (also known as soft tissue augmentation devices) can restore the age-related volume loss of the face, balance the disproportions or correct topographical anomalies. A previous study has already shown the efficacy of Art Filler Volume on the midface, but this study was not comparative. It was thus interesting to compare the efficacy of Art Filler Volume to a reference product but also to test its efficacy on other areas including the temple, jaw-line and chin.

Detailed description

The function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume. These fillers (also known as soft tissue augmentation devices) can restore the age-related volume loss of the face, balance the disproportions or correct topographical anomalies. A previous study has already shown the efficacy of Art Filler Volume on the midface, but this study was not comparative. It was thus interesting to compare the efficacy of Art Filler Volume to a reference product but also to test its efficacy on other areas including the temple, jaw-line and chin. In this context, it is proposed to conduct, in post-CE marking, a randomized, prospective and comparative study in order to document, an adequate aesthetic correction of the treated areas as well as their immediate and long-term tolerance. This study aims to document the filling capacity of Art Filler Volume, in relation to a product technically of the same order and considered as a reference2,3,4,5 (this study will be comparative on temple / midface and jawline but no on the chin were only Art Filler Volume will be injected). To do this, subjects in whom a correction of mid-facial areas and / or temple and / or jaw-lines and / or chin is sought, will be included. The aesthetic correction will be appreciated at 3 weeks. Subjects will be followed over 18 months. The persistence of the correction will be evaluated at 3, 6, 9, 12, 15 and 18 months. No corrective injections with the products under study will be allowed. Each subject could be injected for maximum 2 different zones.

Conditions

• Aging

Interventions

Type	Name	Description
DEVICE	Face correction with injectable fillers	Injection of hyaluronic acid-based fillers

Timeline

• Start date: 2019-05-14
• Primary completion: 2019-08-02
• Completion: 2021-01-25
• First posted: 2020-11-27
• Last updated: 2022-03-08

Locations

1 site across 1 country: France