| Eligibility |
Inclusion Criteria:
1. At the time of consent, women between the ages of 18 and 80 years old;
2. Patient requires lower face treatment (perioral/marionette region) with RADIESSE;
3. Willingness to comply with study requirements;
4. Provide written consent;
5. Patient has a rating of 2 or 3 at Baseline on the Merz Marionette Grading Scale, as
per the investigator;
6. Accepted the obligation not to receive any other facial procedures through the
follow-up;
7. Understood and accepted the obligation and would be logistically able to appear for
all scheduled follow-up visits;
8. No previous facial fillers for a period of 12 months prior to this study;
9. No previous facial fillers in the lower face for 18 months prior to this study.
Exclusion Criteria:
1. 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)];
2. Hypersensitivity to RADIESSE, calcium hydroxylpatite filler or local anesthetics;
3. Patient has received any lower face treatment during the last 12 months, or
neuromodulator in the last 6 months;
4. Patient has received mentalis muscle injections of any kind (BoNT-A or fillers) in the
last 6 months;
5. Patients meeting any official RADIESSE contra-indications;
6. Patients presenting with porphyria;
7. Inability to comply with follow-up and abstain from facial injections during the study
period;
8. Heavy smokers, classified as smoking more than 12 cigarettes per day;
9. History of severe or multiple allergies manifested by anaphylaxis;
10. Previous tissue revitalization therapy in the treatment area within 6 months before
treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy,
chemical peeling, or dermabrasion;
11. Previous surgery including aesthetic facial surgical therapy or liposuction, piercing,
or tattoos in the treatment area;
12. History or presence of any disease or lesion near or at the treatment area, including
inflammation, active or chronic infection, including in the mouth, dentals, head and
neck region;
13. Facial psoriasis, eczema, acne, rosacea, perioral dermatitis and herpes zoster in the
treatment area;
14. Cancer or precancer in the treatment area, e.g. actinic keratosis;
15. History of bleeding disorders or treatment with thrombolytics, anticoagulants, or
inhibitors of platelet aggregation (e.g. Aspirin or other non-steroid
anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment;
16. Patients using immunosuppressants;
17. Patients with a tendency to form hypertrophic scars or any other healing disorders;
18. Patients with known hypersensitivity to lidocaine or agents structurally related to
amide type local anaesthetics (e.g., certain anti-arrhythmics);
19. Patients administered dental block or topical administration of lidocaine;
20. Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic
function or severe renal dysfunction.
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