ClinicalTrials.gg
Sign In
CompletedNCT01559233Updated Mar 21, 2012

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

An interventional study of FPlus RF device for wrinkles and rhytide reduction in Facial Wrinkles and Rhytides Reduction, sponsored by Invasix. Completed at 1 site in Canada. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-21.

Sponsored by Invasix · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Not applicable
Ages
21 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Facial Wrinkles and Rhytides Reduction
03

In context

Lead sponsor

This is the only study on the registry with Invasix as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
  • Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last 3 months.
  • Having received treatment with light, laser, RF, or other devices in the treated area within 6 months.
  • Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
  • Treating over tattoo or permanent makeup.
  • As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    FPlus

    Device: FPlus RF device for wrinkles and rhytide reduction

Interventions

  • DeviceFPlus RF device for wrinkles and rhytide reduction

    Six RF weekly treatments for face wrinkles and rhytides reduction using the FPlus device.

    Also known as: RF treatment

06

What researchers measure

Primary outcomes

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

    Time frame: 4.5 months

Secondary outcomes

  1. Facial wrinkle reduction rate following 6 treatments with the FPlus device, as agreed 3 blinded dermatologists, based on Fitzpatrick wrinkle and elastosis scale.

    Time frame: 4.5 months

07

Study locations

1 site
  • AestheticPlastic Surgery Practice, SpaMedica
    Toronto, ON M5R 3N8, Canada
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2011, a primary completion of Feb 2012 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2012
First posted
Mar 21, 2012
Start
Feb 2011
Primary completionActual
Feb 2012
CompletionActual
Mar 2012
Last update
Mar 21, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01559233
Lead sponsor
Invasix
Responsible party
Sponsor
First posted
Mar 21, 2012
Start date
Feb 2011
Primary completion
Feb 2012
Completion
Mar 2012
Last update
Mar 21, 2012

Study contacts

Robert Stephen Mulholland, Dr.
principal investigator · Invasix

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion