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

Not Applicable

Completed

• Conditions: Facial Wrinkles and Rhytides Reduction
• Interventions: Device: FPlus RF device for wrinkles and rhytide reduction

• Registration Number: NCT01559233
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2012-02
• Status Verified: 2012-03
• Study Completion: 2012-03
• Study First Submitted: 2012-03-17
• Study First Submitted QC: 2012-03-20
• Last Update Submitted: 2012-03-20
• Study First Posted: 2012-03-21
• Last Update Posted: 2012-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FPlus	FPlus RF device for wrinkles and rhytide reduction	-

Primary Outcome Measures

Name	Time	Method
Lack of adverse events during treatments with the FPlus device and 3 months following last treatment.	4.5 months

Secondary Outcome Measures

Name	Time	Method
Facial wrinkle reduction rate following 6 treatments with the FPlus device, as agreed 3 blinded dermatologists, based on Fitzpatrick wrinkle and elastosis scale.	4.5 months

Trial Locations

Locations (1)

AestheticPlastic Surgery Practice, SpaMedica; 🇨🇦 Toronto, Canada