Facial Wrinkles and Rhytides ReductionNCT01559233
Clinical Study to Determine Safety and Efficacy of FPlus for Wrinkle Treatment
A study testing FPlus RF device for wrinkles and rhytide reduction in people with Facial Wrinkles and Rhytides Reduction, run by Invasix at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Wrinkles and Rhytides Reduction
- What is being tested?
- FPlus RF device for wrinkles and rhytide reduction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Facial Wrinkles and Rhytides Reduction
- Being tested
- FPlus RF device for wrinkles and rhytide reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FPlus RF device for wrinkles and rhytide reductionDevice
Also called RF treatment
Six RF weekly treatments for face wrinkles and rhytides reduction using the FPlus device.
| Study group | Role | What they receive |
|---|---|---|
| FPlus | Experimental | Not described Receives: Device: FPlus RF device for wrinkles and rhytide reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lack of adverse events during treatments with the FPlus device and 3 months following last treatment.
Measured: 4.5 months
Secondary outcomes (1)
Facial wrinkle reduction rate following 6 treatments with the FPlus device, as agreed 3 blinded dermatologists, based on Fitzpatrick wrinkle and elastosis scale.
Measured: 4.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Wrinkles and Rhytides ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invasix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Stephen Mulholland, Dr., Principal investigator, Invasix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559233
- Sponsor's protocol ID
- FP1
- Status last verified
- Mar 2012
- First submitted
- 17 Mar 2012
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Determine Safety and Efficacy of FPlus for Wrinkle Treatment
- ClinicalTrials.gov ID
- NCT01559233
- Acronym / sponsor ID
- FP1
- Conditions
- Facial Wrinkles and Rhytides Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- InvasixIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FPlus | Experimental | Device: FPlus RF device for wrinkles and rhytide reduction |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FPlus RF device for wrinkles and rhytide reductionAlso: RF treatmentSix RF weekly treatments for face wrinkles and rhytides reduction using the FPlus device. | Device | FPlus |
Primary outcome
Lack of adverse events during treatments with the FPlus device and 3 months following last treatment.
Time frame: 4.5 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Stephen Mulholland, Dr. principal investigator
Invasix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FPlus RF device for wrinkles and rhytide reduction in people with Facial Wrinkles and Rhytides Reduction, run by Invasix at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lack of adverse events during treatments with the FPlus device and 3 months following last treatment. (time frame: 4.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2012.