Clinical trial NCT04172740: RADIESSE Injection in Perioral and Marionette Lines
Official title: Assessment of Skin Quality Parameters Following RADIESSE Injection in Perioral and Marionette Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Quality
Lead sponsor: Erevna Innovations Inc.
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Hydration
timeFrame: Month 3
Secondary outcomes:
measure: Hydration
timeFrame: Month 6
measure: Elasticity
timeFrame: Month 3 and 6
measure: pH
timeFrame: Month 3 and 6
measure: Skin texture
timeFrame: Month 3 and 6
measure: Merz validated marionette scale
timeFrame: Month 3 and 6
measure: Global Assessment Improvement Scale
timeFrame: Months 3 and 6
measure: Fitzpatrick Wrinkle Assessment Scale
timeFrame: Months 3 and 6
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Erevna Innovations Inc
state: Quebec
Study officials:
affiliation: Erevna Innovations Inc.
name: Andreas Nikolis, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: