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RADIESSE Injection in Perioral and Marionette Lines | Clinical Trials | Clareo Health

COMPLETEDNA

RADIESSE Injection in Perioral and Marionette Lines

Assessment of Skin Quality Parameters Following RADIESSE Injection in Perioral and Marionette Lines

NCT04172740•Erevna Innovations Inc.

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

Age

18 - 80 years

Sex

FEMALE

Healthy Volunteers

Yes

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;
+10 more criteria

Locations (1)

Erevna Innovations Inc

Montreal, Quebec, Canada

Key Dates

Start Date

November 13, 2019

Primary Completion Date

July 11, 2020

Completion Date

July 11, 2020

Last Updated

August 23, 2021

Enrollment

ACTUAL participants

Conditions

Skin Quality

Interventions

Radiesse (calcium hydroxylpatite)

DEVICE

Prospective Clinical Investigation to Evaluate the Safety and Effectiveness of Juläine™ in Improving Gluteal Skin Laxity in Adults.

NCT07332650

Skin QualitySkin Laxity

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NOT_YET_RECRUITINGNA

A Study to Evaluate the Safety and Effectiveness of Kytogen Defend in Facial Skin Quality Improvement in Adult Participants

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 23, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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RADIESSE Injection in Perioral and Marionette Lines

Inclusion Criteria

Exclusion Criteria

Prospective Clinical Investigation to Evaluate the Safety and Effectiveness of Juläine™ in Improving Gluteal Skin Laxity in Adults.

A Study to Evaluate the Safety and Effectiveness of Kytogen Defend in Facial Skin Quality Improvement in Adult Participants

A Study to Evaluate the Safety and Effectiveness of ELAPR002f Injectable Gel for the Improvement of Skin Quality in Adult Participants

Laser Treatment to Improve Skin Quality