Evaluation of the Efficacy and Safety of Three Injectable Hyaluronic Acid-based Fillers: Art Fill… (NCT04647513) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Efficacy and Safety of Three Injectable Hyaluronic Acid-based Fillers: Art Filler® Fine Lines, Art Filler® Universal and Art Filler® Lips
France232 participantsStarted 2019-04-12
Plain-language summary
The function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume and the aging process. These fillers (also known as soft tissue augmentation medical devices) can correct the skin depressions/wrinkles, balance the disproportions or correct topographical anomalies.
In this context, it is proposed to carry out in post-CE marking, an open, prospective and non-comparative study in order to document an adequate aesthetic correction of the most frequent areas treated with Art Filler Fine Lines, Art Filler Universal and Art Filler Lips as well as their immediate and long-term tolerance.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Subjects who had signed a written informed consent
✓. Man or Woman aged ≥ 19 years old
✓. Subject having a Fitzpatrick Phototype I to IV
✓. Subject having a score of ≥ 1 in the Global aesthetic scale scoring system on at least one area of interest (forehead wrinkles, upper lip wrinkles, cheek folds, crow's feet wrinkles, nasolabial folds and/or marionette wrinkles) and/or ≤ 2 for the lip volume
✓. Subject having at least one of the following scales by clinical scoring
✓. Subject registered with health insurance regimen
✓. Woman agreeing to take a pregnancy test
Exclusion criteria
✕. Subject currently participating in another clinical study related to pharmaceuticals or medical devices or being in exclusion period of another clinical study.
✕. Subject deprived of freedom by an administrative or legal decision
What they're measuring
1
Correction on D21 assessed with the global clinical aesthetic score
. Subject who has received indemnification of 4500 € during the 12 previous months for his/her participation in clinical trials (including participation in this study).
✕. Subject who had facial injections/implants of any non-absorbable fillers in her/his whole life.
✕. Subject who had laser sessions for skin rejuvenation or laser resurfacing during the 12 previous months or a surgical facelift during the 2 years before the study.
✕. Subject with a history of facial aesthetic injection (hyaluronic acid within the previous year, botulinum toxin within the last 6 months and long-term temporary injectable implants (semi-permanent implants) within the previous 2 years).
✕. Subject with a skin-retaining device on the face (mesh, gold wire, liquid silicone or other particulate material).
✕. Subject who underwent a non-invasive rejuvenation method such as moderate to deep peeling, ultrasound, radiofrequency devices or lasers within the last 6 months.