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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Art Filler Fine Lines (forehead) | Experimental | Injection of Art Filler Fine Lines in Forehead wrinkles |
|
| Art Filler Fine Lines (upper lip) | Experimental | Injection of Art Filler Fine Lines in upper lip wrinkles |
|
| Art Filler Fine Lines (cheek folds) | Experimental | Injection of Art Filler Fine Lines in cheek folds |
|
| Art Filler Fine Lines (crow's feet) | Experimental | Injection of Art Filler Fine Lines in crow's feet |
|
| Art Filler Universal (lips volume) | Experimental | Injection of Art Filler Universal in lips |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Correction on D21 assessed with the global clinical aesthetic score | Objectively measure the improvement according to a global Aesthetic clinical scoring from D0 to D21 of
| D21 (21 days after the injections) |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Ferial Fanian, MD | Laboratoires FILLMED | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Mihai Gorj | Paris | 75116 | France |
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Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips). To this end, subjects in whom a correction of at least one of the studied zones 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.
Around 200 subjects aged more than 19 years old with following distribution:
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|
| Art Filler Universal (nasolabial folds) | Experimental | Injection of Art Filler Universal in nasolabial folds |
|
| Art Filler Lips (lips volume) | Experimental | Injection of Art Filler Lips in lips |
|
| Art Filler Lips (very deep nasolabial folds) | Experimental | Injection of Art Filler Lips in very deep nasolabial folds |
|
|
| ID | Term |
|---|---|
| D007271 | Injections, Intradermal |
| ID | Term |
|---|---|
| D007279 | Injections, Subcutaneous |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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