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The study aims to confirm the safety and effectiveness of FILLGEL devices
Full description
The primary objective is to evaluate the effectiveness of the FILLGEL range used on different treated zones one month (M1) after treatment using clinical evaluation of the global aesthetic improvement (GAIS) rated by the independent investigator. The secondary objectives of the study are to collect data for the
FILLGEL range on:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Healthy Subject.
Sex: male or female.
Age: between 18 and 65 years.
Subject seeking an improvement of her/his face aspect with Hyaluronic Acid (HA) filler.
For group 1: Subject with moderate to severe peri-oral lines (score 3 to 5 on Bazin Upper lip scale) ;
For group 2: Subject with moderate to severe nasolabial folds (score 3 to 4 on WSRS scale) and/or subject with thin lips (score
1 or 2 for superior and/or inferior lip on the Rossi scale) and seeking an improvement of lip volume;
For group 3: Subject with moderate to severe cheeks/cheekbones volume deficit (score 3 to 4 on Ascher lipoatrophy scale);
For group 4: Subject with moderate to severe cheeks/cheekbones volume deficit (score 3 to 4 on Ascher lipoatrophy scale) and/or subject seeking improvement of chin enhancement.
Subject whose weight did not fluctuate in the last 6 months and who agrees to keep a stable weight during the study.
Subject having given their free, express, and informed consent.
Subject psychologically able to understand the information related to the study, and to give their written informed consent.
Subject registered with a social security scheme.
Women of childbearing potential should use a contraceptive method considered effective since at least 4 weeks and throughout the study
Exclusion criteria
In terms of population
Primary purpose
Allocation
Interventional model
Masking
68 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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