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 range

18 Years – 80 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hydration

Timeframe: Month 3

Trial details

NCT IDNCT04172740

SponsorErevna Innovations Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-11

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