CompletedNot Applicable

Clinical Study to Determine Safety and Efficacy of FPlus for Wrinkle Treatment

Canada69 participantsStarted 2011-02

Plain-language summary

Patient demand for non-surgical, non-invasive, and no-downtime wrinkle and rhytides treatment procedures has grown dramatically over the past decade as new treatments and technologies have been introduced. This study was performed in order to evaluate the efficacy and safety of the Invasix FPlus System, an innovative noninvasive system intended for wrinkles and rhytides treatment. Subjects were treated for face wrinkles and rhytides reduction and followed for 3 months after last treatment. In order to evaluate treatment efficacy, pre and post treatment photos were introduced to three uninvolved physicians for blinded evaluation.

Who can participate

Age range

21 Years – 65 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.

Inclusion Criteria: * Subjects with mild to moderate facial wrinkles and rhytides . * Males and females 21 - 65 years of age. * Willingness to follow the treatment schedule, and have photographs taken. Exclusion Criteria: * Pacemaker or internal defibrillator, or other implanted metallic or electronic device. * Permanent implant in the treated area such as metal plates and screws or silicon, unless deep enough in the periosteal plane. * Avoid treatment if intra-dermal or superficial sub-dermal areas have been injected with Botox/HA/collagen/fat injections or other augmentation methods with bio-material during last 6 months. * Current or history of skin cancer, or any other type of cancer, or pre-malignant moles. * Severe concurrent conditions, such as cardiac disorders. * Pregnancy or nursing. * Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications. * Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime. * Poorly controlled endocrine disorders, such as diabetes. * Any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash. * History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. * History of bleeding coagulopathies, or use of anticoagulants in the last 10 days. * Any facial surgery performed within 12 months prior to treatment.…

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

Lack of adverse events during treatments with the FPlus device and 3 months following last treatment.

Timeframe: 4.5 months

Trial details

NCT IDNCT01559233

SponsorInvasix

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-02

View on ClinicalTrials.gov More Facial Wrinkles and Rhytides Reduction trials