- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01559233
Clinical Study to Determine Safety and Efficacy of FPlus for Wrinkle Treatment
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Toronto, Canada, ON M5R 3N8
- AestheticPlastic Surgery Practice, SpaMedica
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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Six RF weekly treatments for face wrinkles and rhytides reduction using the FPlus device.
Other Names:
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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
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4.5 months
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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
Sponsor
Investigators
- Principal Investigator: Robert Stephen Mulholland, Dr., Invasix
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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