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

March 20, 2012 updated by: Invasix

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FPlus
Six RF weekly treatments for face wrinkles and rhytides reduction using the FPlus device.
Other Names:
  • RF treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lack of adverse events during treatments with the FPlus device and 3 months following last treatment.
Time Frame: 4.5 months
4.5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Robert Stephen Mulholland, Dr., Invasix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

March 17, 2012

First Submitted That Met QC Criteria

March 20, 2012

First Posted (Estimate)

March 21, 2012

Study Record Updates

Last Update Posted (Estimate)

March 21, 2012

Last Update Submitted That Met QC Criteria

March 20, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • FP1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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