RADIESSE Injection in Perioral and Marionette Lines

NCT04172740 | Completed

• 1 other identifier: 2019-VP-003R
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Skin Quality

Outcome Measures

Primary Outcomes (1)

• Hydration

  Assessment of changes in hydration at Month 3, as assessed with the Courage and Khazaka system device, following the injection of RADIESSE, in perioral and marionette lines regions

  Month 3

Secondary Outcomes (7)

• Hydration

  Month 6

• Elasticity

  Month 3 and 6

• pH

  Month 3 and 6

• Skin texture

  Month 3 and 6

• Merz validated marionette scale

  Month 3 and 6

Study Arms (1)

Treatment

EXPERIMENTAL

Device: Radiesse (calcium hydroxylpatite)

Interventions

Radiesse (calcium hydroxylpatite) DEVICE

RADIESSE® injectable implant is a sterile, non-pyrogenic, semi-solid, cohesive implant, whose principle component is synthetic calcium hydroxylapatite (CaHA) suspended in a gel carrier of sterile water for injection, glycerin and sodium carboxymethylcellulose. RADIESSE injectable implant has a CaHA particle size range of 25-45 microns. RADIESSE is available in 1.5cc and 0.8cc pre-filled syringes. RADIESSE injectable implant is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy).

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• No previous facial fillers in the lower face for 18 months prior to this study.

You may not qualify if:

• 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;
• Patients meeting any official RADIESSE contra-indications;
• Patients presenting with porphyria;
• Inability to comply with follow-up and abstain from facial injections during the study period;
• Heavy smokers, classified as smoking more than 12 cigarettes per day;
• History of severe or multiple allergies manifested by anaphylaxis;
• 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;
• Previous surgery including aesthetic facial surgical therapy or liposuction, piercing, or tattoos in the treatment area;
• 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;
• Facial psoriasis, eczema, acne, rosacea, perioral dermatitis and herpes zoster in the treatment area;
• Cancer or precancer in the treatment area, e.g. actinic keratosis;
• 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;

Sponsors & Collaborators

• Erevna Innovations Inc.: lead

Study Sites (1)

Erevna Innovations Inc

Montreal, Quebec, H3R 3A1, Canada

Location

Study Officials

• Andreas Nikolis, FRCSC

  Erevna Innovations Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 21, 2019
• Study Start: November 13, 2019
• Primary Completion: July 11, 2020
• Study Completion: July 11, 2020
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

CA (1)