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

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ClinicalTrials.gov Identifier: NCT01559233
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : March 21, 2012
Sponsor:
Information provided by (Responsible Party):
Invasix

Brief 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.


Condition or disease Intervention/treatment Phase
Facial Wrinkles and Rhytides Reduction Device: FPlus RF device for wrinkles and rhytide reduction Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Determine Safety and Efficacy of FPlus for Wrinkle Treatment
Study Start Date : February 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Lack of adverse events during treatments with the FPlus device and 3 months following last treatment. [ Time Frame: 4.5 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559233


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

Responsible Party: Invasix
ClinicalTrials.gov Identifier: NCT01559233     History of Changes
Other Study ID Numbers: FP1
First Posted: March 21, 2012    Key Record Dates
Last Update Posted: March 21, 2012
Last Verified: March 2012