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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Invasix
ClinicalTrials.gov Identifier:
NCT01559233
First received: March 17, 2012
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Facial Wrinkles and Rhytides Reduction
 Device: FPlus RF device for wrinkles and rhytide reduction

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study to Determine Safety and Efficacy of FPlus for Wrinkle Treatment

Further study details as provided by Invasix:

Primary Outcome Measures:
  • Lack of adverse events during treatments with the FPlus device and 3 months following last treatment. [ Time Frame: 4.5 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: February 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FPlus Device: FPlus RF device for wrinkles and rhytide reduction
Six RF weekly treatments for face wrinkles and rhytides reduction using the FPlus device.
Other Name: RF treatment

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559233

Locations
Canada
AestheticPlastic Surgery Practice, SpaMedica
Toronto, Canada, ON M5R 3N8
Sponsors and Collaborators
Invasix
Investigators
Principal Investigator: Robert Stephen Mulholland, Dr. Invasix
  More Information

No publications provided

Responsible Party: Invasix
ClinicalTrials.gov Identifier: NCT01559233     History of Changes
Other Study ID Numbers: FP1
Study First Received: March 17, 2012
Last Updated: March 20, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2013