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Evaluation of the Long Term Efficacy and Tolerability of ART FILLER® Volume and Lips

NCT05456971 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2022-07-13

No results posted yet for this study

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. Art Filler® Volume and Art Filler Lips are two hyaluronic-based fillers. Both contain 0.3% lidocaine hydrochloride for its anaesthetic properties. The difference between the two devices lies in their viscosity, which must be adapted for the regions being treated and to restoring facial volumes. Midface for Art Filler® Volume and Lips for Art filler® Lips. On this background, a study is conducted to evaluate the long term efficacy and tolerability of Art Filler® Volume and Art Filler® Lips. It is a prospective, non-comparative, multicentre study with long term evaluation (18 months) of the tolerability and assessment of the efficacy of two devices containing hyaluronic acid intended for filling of lines and restoring volume to the face and lips.

Conditions

  • Aging

Interventions

DEVICE

Art Filler Volume

Midface correction with injectable hyaluronic acid based-filler

DEVICE

Art Filler Lips

Lipscorrection with injectable hyaluronic acid based-filler

Sponsors & Collaborators

  • Laboratoires FILLMED

    lead INDUSTRY

Principal Investigators

  • Ferial Fanian, MD · Laboratoires FILLMED

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-12
Primary Completion
2016-12-29
Completion
2018-05-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05456971 on ClinicalTrials.gov