CompletedPhase 4

HArmonyCa Injectable Gel for Mid Face Soft Tissue Augmentation

France140 participantsStarted 2021-10-13

Plain-language summary

Prospective, open label, post marketing study of the safety and effectiveness of HArmonyCa injectable gel for mid-face soft tissue augmentation

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

Exclusion criteria

. in patients with a known sensitivity to any of the product components.
. in patients suffering from skin disease or abnormal skin conditions.
. in patients suffering from an infection or inflammation (either acute or chronic) at or near the treatment site.
. in patients susceptible to keloid formation, hypertrophic scarring, or developing inflammatory skin conditions.
. in patients with impaired wound healing due to systemic disorders, medicinal drugs, or unhealthy or poorly-vascularized tissue.
. in patients suffering from prolonged bleeding or tissue healing due to medical conditions or medicinal drugs.
. in patients with a history of anaphylactic reactions and/or multiple severe allergies.
. in patients with a known sensitivity to steroids, or who are contraindicated to be treated with steroids.

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

Responder status of achieving ≥ 1-grade improvement from baseline on Mid Face Volume Deficit Scale (MFVDS) based on EI's (Evaluating Investigator) live assessment at Month 1

Timeframe: 1 Month

Trial details

NCT IDNCT05119777

SponsorAllergan

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-15

View on ClinicalTrials.gov More Soft Tissue Augmentation trials