WrinklesNCT01859611
TriActive+ Radiofrequency (RF) for Non-Invasive Treatment of Wrinkles and Rhytides
A study testing TriActive+ RF in people with Wrinkles and Rhytides, run by El. En. SpA at 2 sites in United States.
Trial summary
The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source, the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple treatments. The primary endpoint is observation of changes to the surface by visual and photographic analysis. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- What is being tested?
- TriActive+ RF
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2013to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ICA signed by the subject.
- Healthy male or female subjects 30-60 ys of age.
- Having at least 2 facial sub-areas (left peri-orbital, right peri-orbital or peri-oral) with visible lines/wrinkles and elastosis, which correlate to a score of 2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis.
- Willingness to follow the treat and FU schedule and the post-treat care.
- For female candidates - post-menopausal or surgically sterilized or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire study
Who cannot join
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breastfeeding. Females of childbearing potential must agree to take a urine pregnancy test (must be negative) at the Screening visit. Females of childbearing potential include anyone who has experienced menarche and who has not undergone successful surgical sterilization or is not post-menopausal for more than 2 years.
- Having any active electrical implant anywhere in the body
- Having a permanent implant in the treated area or an injected chemical substance.
- Having a history of diseases stimulated by heat unless treatment is conducted following a prophylactic regimen.
- Use of non-steroidal anti-inflammatory drugs one week before and after each treatment session.
- Use of retinoids, antioxidants or skin nourishing supplements within 1 month of treatment or during the study.
Show all 25Show fewer
- Having received a facial dermabrasion or chemical peel treatment within 2 months of treatment or during the study.
- Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
- Having received Botox in the treated area within 6 months or collagen/Hyaluronic Acid within a year of treatment or during the study.
- Having undergone a resurfacing procedure, face lift or eyelid surgery within a year of treatment or during the study.
- Having undergone any other surgery in the treated area within 6 months of treatment (or more if skin has not healed completely) or during the study.
- Having ever received fat injections or other methods of augmentation with injected or implanted material in the treated area or planning to during the study.
- History of keloid scarring or of abnormal wound healing.
- Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- History of epidermal or dermal disorders.
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Suffering from hormonal imbalance, as per the Investigator's discretion.
- Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course.
- Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
- Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
- Vascular lesion, tattoo or permanent make-up in the treated area.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Participation in a study of another device or drug within 1 month prior to enrollment or during the study.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Chernoff Plastic Surgery & Laser Center
Indianapolis, Indiana, 46260
Park Avenue SmartLipo
New York, New York, 10019
About this study
Official title: Clinical Study to Evaluate the Performance of TriActive+ RF for the Non-Invasive Treatment of Wrinkles and Rhytides
The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source, the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple treatments. The primary endpoint is observation of changes to the surface by visual and photographic analysis. Secondary endpoints: measurement of patient satisfaction and comfort of the treatment and the measurement of adverse events.
Read the detailed description
Collagen varies genetically and structurally. Collagen breakdown increases with chronological age and photoaging. While fibroblasts normally replace damaged collagen fibers with new ones, the ability of fibroblasts to replace collagen is compromised by natural aging and environmental stress. Although collagen fibers form a loose interlacing network that is deformable, increased collagen breakdown leads to thinning and loss of the elastic fiber network in the dermis. This breakdown results in the formation of wrinkles, especially in areas of the skin exposed to the sun, which are most prone to wrinkles and imperfections. Nonablative dermal remodeling has gained tremendous popularity among patients and practitioners, offering a low incidence of adverse effects and modest improvement in the various signs of cutaneous photoaging, including rhytides, dyschromias and telangiectasias. Controlled thermal skin injury has been shown to effect a conformational change in the structure and length of collagen and may also induce fibroblast response for long-term collagen remodeling. Interest in utilizing radiofrequency energy to enhance deep tissue tightening and thus improve skin laxity has grown, as radiofrequency energy has been shown in multiple studies to tighten tissue, producing a noticeable skin lifting.
This study is intended to evaluate the clinical performance of a radiofrequency (RF) source as engendered in the TriActive+ RF for the non-invasive treatment of wrinkles and rhytides.
Eligible subjects who have signed an ICF will receive up to 8 treatments on at least two facial sub areas (left peri-orbital, right peri-orbital and peri-oral). Up to 25 subjects will be enrolled in the study at two sites. Treatments will start at a low power and then gradually increase, based on tolerability and tissue reaction. The goal is to progressively reach and maintain an epidermal temperature end-point. The site will use an IR thermometer to ensure the rise in temperature does not exceed 43° C.
Treatments will be once a week with follow-up visits at one week, one month, and three months following the final treatment. Clinical assessments by the investigator and digital photographs will be taken prior to the baseline treatment, immediately prior to the 5th treatment, and at the 1 week, 1 month and 3 month follow-up visits.
- Being tested
- TriActive+ RF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriActive+ RFDevice
Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special "skin contact identification" system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency | Experimental | Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks. Receives: Device: TriActive+ RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes to the Surface by Visual and Photographic Analysis.
At each of the specified time points, photographs of the treated areas will be taken. The photography angles will include a global frontal photo and the right and left sides of the face at 45° and/or 90°. In addition, close up photos will be taken of specific facial zones, e.g., the peri-orbital wrinkles.
Each patient to be evaluated through the 9 grade Fitzpatrick Wrinkling Severity Scale.
Wrinkling Score Degree of Elastosis Fine 1-3 Mild Fine to moderate 4-6 Moderate Fine to deep wrinkles 7-9 Severe
Measured: 3 Month FU
Secondary outcomes (2)
Patient Satisfaction and Comfort of the Treatment.
At each of the specified time points, subjects will complete a Subject Evaluation Form assessing their opinion of improvement and overall satisfaction with treatment.
Measured: Pre Treatment 5, 1 Week FU, 1 Month FU, 3 Month FU
Adverse Events.
At every treatment and follow-up visit the treated areas will be examined to evaluate side effects and adverse reactions remaining from the previous treatment session or occurring since then.
Measured: Subjects will be followed for the duration of the study, and expected average of 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WrinklesStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- El. En. SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alessandro Bizzari, ElEn, Study director, El. En. SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859611
- Sponsor's protocol ID
- TriActive+RF-ElEn-022013
- Status last verified
- Mar 2015
- First submitted
- 10 May 2013
- Last updated
- 7 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Performance of TriActive+ RF for the Non-Invasive Treatment of Wrinkles and Rhytides
- ClinicalTrials.gov ID
- NCT01859611
- Acronym / sponsor ID
- TriActive+RF-ElEn-022013
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- El. En. SpAIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Posted 11 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source, the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple treatments. The primary endpoint is observation of changes to the surface by visual and photographic analysis. Secondary endpoints: measurement of patient satisfaction and comfort of the treatment and the measurement of adverse events.
Detailed description
Collagen varies genetically and structurally. Collagen breakdown increases with chronological age and photoaging. While fibroblasts normally replace damaged collagen fibers with new ones, the ability of fibroblasts to replace collagen is compromised by natural aging and environmental stress. Although collagen fibers form a loose interlacing network that is deformable, increased collagen breakdown leads to thinning and loss of the elastic fiber network in the dermis. This breakdown results in the formation of wrinkles, especially in areas of the skin exposed to the sun, which are most prone to wrinkles and imperfections. Nonablative dermal remodeling has gained tremendous popularity among patients and practitioners, offering a low incidence of adverse effects and modest improvement in the various signs of cutaneous photoaging, including rhytides, dyschromias and telangiectasias. Controlled thermal skin injury has been shown to effect a conformational change in the structure and length of collagen and may also induce fibroblast response for long-term collagen remodeling. Interest in utilizing radiofrequency energy to enhance deep tissue tightening and thus improve skin laxity has grown, as radiofrequency energy has been shown in multiple studies to tighten tissue, producing a noticeable skin lifting.
This study is intended to evaluate the clinical performance of a radiofrequency (RF) source as engendered in the TriActive+ RF for the non-invasive treatment of wrinkles and rhytides.
Eligible subjects who have signed an ICF will receive up to 8 treatments on at least two facial sub areas (left peri-orbital, right peri-orbital and peri-oral). Up to 25 subjects will be enrolled in the study at two sites. Treatments will start at a low power and then gradually increase, based on tolerability and tissue reaction. The goal is to progressively reach and maintain an epidermal temperature end-point. The site will use an IR thermometer to ensure the rise in temperature does not exceed 43° C.
Treatments will be once a week with follow-up visits at one week, one month, and three months following the final treatment. Clinical assessments by the investigator and digital photographs will be taken prior to the baseline treatment, immediately prior to the 5th treatment, and at the 1 week, 1 month and 3 month follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency | Experimental | Device: TriActive+ RFRadiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ICA signed by the subject.
- Healthy male or female subjects 30-60 ys of age.
- Having at least 2 facial sub-areas (left peri-orbital, right peri-orbital or peri-oral) with visible lines/wrinkles and elastosis, which correlate to a score of 2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis.
- Willingness to follow the treat and FU schedule and the post-treat care.
- For female candidates - post-menopausal or surgically sterilized or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire study
Key exclusion criteria (25 listed)
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breastfeeding. Females of childbearing potential must agree to take a urine pregnancy test (must be negative) at the Screening visit. Females of childbearing potential include anyone who has experienced menarche and who has not undergone successful surgical sterilization or is not post-menopausal for more than 2 years.
- Having any active electrical implant anywhere in the body
- Having a permanent implant in the treated area or an injected chemical substance.
- Having a history of diseases stimulated by heat unless treatment is conducted following a prophylactic regimen.
- Use of non-steroidal anti-inflammatory drugs one week before and after each treatment session.
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 |
|---|---|---|
| TriActive+ RFRadio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special "skin contact identification" system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts. | Device | Radiofrequency |
Primary outcome
Changes to the Surface by Visual and Photographic Analysis.
Time frame: 3 Month FU
At each of the specified time points, photographs of the treated areas will be taken. The photography angles will include a global frontal photo and the right and left sides of the face at 45° and/or 90°. In addition, close up photos will be taken of specific facial zones, e.g., the peri-orbital wrinkles. Each patient to be evaluated through the 9 grade Fitzpatrick Wrinkling Severity Scale. Wrinkling Score Degree of Elastosis Fine 1-3 Mild Fine to moderate 4-6 Moderate Fine to deep wrinkles 7-9 Severe
2 secondary outcomes
Patient Satisfaction and Comfort of the Treatment.
Time frame: Pre Treatment 5, 1 Week FU, 1 Month FU, 3 Month FU
Adverse Events.
Time frame: Subjects will be followed for the duration of the study, and expected average of 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alessandro Bizzari, ElEn study director
El. En. SpA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TriActive+ RF in people with Wrinkles and Rhytides, run by El. En. SpA at 2 sites in United States.
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 5 inclusion and 25 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 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes to the Surface by Visual and Photographic Analysis. (time frame: 3 Month FU). 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 7 Apr 2015.