Clinical Evaluation of the Safety and Performance of a Filler in Correction of Mid-face Age-relat… (NCT04505319) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of the Safety and Performance of a Filler in Correction of Mid-face Age-related Volume Deficit
France50 participantsStarted 2020-09-14
Plain-language summary
Prospective, single center study, on healthy subjects to evaluate the aesthetic improvement of facial volume, effect on the restoration and/or augmentation in subjects with mid-face age-related volume deficit after injection of a filler with lidocaine.
Who can participate
Age range40 Years – 60 Years
SexFEMALE
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Inclusion criteria
✓. Healthy subject;
✓. Sex: female;
✓. Age: between 40 and 60 years;
✓. BMI between 18 and 25 included.
✓. Subject having given freely and expressly his informed consent;
✓. Subject with a volume deficit on malar area and requiring a correction using a filler;
✓. Subject, psychologically able to understand the study related information and to give a written informed consent;
✓. Subject affiliated to a health social security system;
Exclusion criteria
✕. Pregnant or nursing woman or planning a pregnancy during the study.
✕. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
✕. Subject in a social or sanitary establishment.
✕. Subject participating to another research on human beings or being in an exclusion period for a previous study.
✕. Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.
What they're measuring
1
Global aesthetic improvement one month
Timeframe: one month after injection (first visit from Day 0)
. Intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
✕. Subject with a tattoo, a scar, moles, pigment disorders or anything on the studied zones which may interfere with the study at the investigator appreciation.
✕. Subject with unstable weight or planning to do a dietary regime during the study.