RADIESSE Injection in Perioral and Marionette Lines (NCT04172740) | Clinical Trial Compass
CompletedNot Applicable
RADIESSE Injection in Perioral and Marionette Lines
Canada10 participantsStarted 2019-11-13
Plain-language summary
Following treatment with Radiesse, many patients mention an improvement in skin texture This observation is independent from the improvement observed on their facial shape. There is therefore a need to identify and quantify changes in skin parameters following treatment with Radiesse
Who can participate
Age range18 Years – 80 Years
SexFEMALE
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Inclusion criteria
✓. At the time of consent, women between the ages of 18 and 80 years old;
✓. Patient requires lower face treatment (perioral/marionette region) with RADIESSE;
✓. Willingness to comply with study requirements;
✓. Provide written consent;
✓. Patient has a rating of 2 or 3 at Baseline on the Merz Marionette Grading Scale, as per the investigator;
✓. Accepted the obligation not to receive any other facial procedures through the follow-up;
✓. Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
✓. No previous facial fillers for a period of 12 months prior to this study;
Exclusion criteria
✕. Current Pregnancy or lactation \[sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)\];
✕. Hypersensitivity to RADIESSE, calcium hydroxylpatite filler or local anesthetics;
✕. Patient has received any lower face treatment during the last 12 months, or neuromodulator in the last 6 months;
✕. Patient has received mentalis muscle injections of any kind (BoNT-A or fillers) in the last 6 months;