StriaeNCT01788748
Evaluation of Fractional Bipolar Radiofrequency for the Treatment of Striae
A study testing bipolar radiofrequency and infrared and fractional bipolar radiofrequency in people with Striae, run by Candela France at 2 sites in France.
Trial summary
This is an interventional open prospective randomized study, done in two sites. The main purpose of this study is to evaluate the efficacy of the combination of bipolar radiofrequency potentiated by an infrared light followed by fractional bipolar radiofrequency for the treatment of striae on the abdomen. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Striae
- What is being tested?
- bipolar radiofrequency and infrared and fractional bipolar radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2013to Nov 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subject over 18 years old, with striae on all the abdomen (white or red)
- Consent form signed by subjects
- Affiliation to social security
Who cannot join
- Electrical implants (pace maker, defibrillator) or superficial metallic implants (gold thread…)
- Pregnant woman
- Woman who can procreate without using an effective birth control
- Deficient immune system due to immunosuppressive diseases such as AIDS or HIV, or use of immunosuppressive drugs,
- Stretch marks resulting from treatment with steroids,
- Treatment with oral retinoids ongoing or stopped less than a year ago, or photosensitizing ongoing or stopped less than 3 months ago
Show all 15Show fewer
- History of diseases stimulated by heat (recurrent herpes) on the treatment area
- Procedure less than 6 months ago performed on the treatment area,
- History of keloid scarring or difficulty in healing,
- History of allergy to xylocaine (for subjects who will have biopsy)
- Dermatological disorder requiring systemic therapy or local therapy in the area under study,
- Systemic disease in evolution (cancer or history of cancer, heart disease, uncontrolled diabetes, pain syndrome, history of neuropathy)
- Problem of coagulation and / or anticoagulant therapy,
- Vascular lesions or tattoos on the treatment area,
- Vulnerable Person: minor, under protection, deprived of liberty.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Aesthetics
Bordeaux, 33200
CHU Archet II, Service de Dermatologie
Nice, 06200
About this study
Official title: Evaluation of Fractional Bipolar Radiofrequency, and Bipolar Radiofrequency Potentiated by Infrared, in Monotherapy or Combined, for the Treatment of Striae
This is an interventional open prospective randomized study, done in two sites.
The main purpose of this study is to evaluate the efficacy of the combination of bipolar radiofrequency potentiated by an infrared light followed by fractional bipolar radiofrequency for the treatment of striae on the abdomen.
In order to have a more complete and accurate study, each technology will also be evaluated separately. This will allow the comparison of the effect of each treatment, in monotherapy or combined.
Read the detailed description
Stria is a very common condition that affects psychologically and aesthetically a lot of patients. It is a linear atrophic scar. So, to be treated, it needs to have both a superficial and a deep impact.
Several technologies have already been tested for this indication, but none of them have been proved at the same time effective and without a high risk of side effects for all skin types. As radiofrequency is an electrical current, it is not absorbed and does not see melanin. So it can be used on all skin types.
When using fractional bipolar radiofrequency, the current goes from small electrodes to return electrodes. Around the small electrodes appear some epidermal ablation, coagulation and deeper thermal damage. This means it has a superficial and a deep effect.
Using infrared combined with bipolar radiofrequency allows the infrared to pre-heat the skin so as to help the radiofrequency to go deeper in the skin more easily. This has a deep effect in the dermis.
In this study, both technologies will be used. At least 20 patients will be treated in two different sites.
The abdomen of each patient will be divided in four quadrants around the navel. Each quadrant will receive a total of three treatments one month apart:
- One quadrant will be the control (no treatment will be done)
- One quadrant will receive each time only bipolar radiofrequency potentiated by infrared
- One quadrant will receive each time only fractional bipolar radiofrequency
- One quadrant will receive each time first bipolar radiofrequency potentiated by infrared, followed in the same session by fractional bipolar radiofrequency.
The choice of the treatment for each area will be randomized at the enrollment of the patient in the study.
There will be two follow-up sessions 3 and 6 months after the last treatment.
The evaluation will be done mainly by 3D acquisitions. This will allow measuring the length, width and depth of the striae and evaluating their evolution after the treatment.
Some patients, if they agree, will also have in vivo confocal microscopy before the first treatment and 6 months after the last one. This will give more information on the collagen and elastin changes.
Four patients, who accept it, will have biopsies performed before the first treatment and 6 months after the last one to also show the evolution of the skin structure.
- Conditions
- Striae
- Being tested
- bipolar radiofrequency and infrared, fractional bipolar radiofrequency
- Keywords
- fractional, bipolar, radiofrequency, striae, infrared, combined
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bipolar radiofrequency and infraredDevice
Also called Applicator Sublime on the platform eTwo
fractional bipolar radiofrequencyDevice
Also called applicator Sublative, platform eTwo
| Study group | Role | What they receive |
|---|---|---|
| bipolar radiofrequency and infrared | Active comparator | The abdomen of each patient will be divided in four quadrants around the navel. One quadrant, selected randomly at the subject enrollment, will receive only bipolar radiofrequency potentiated by infrared, 3 treatments one month apart. Receives: Device: bipolar radiofrequency and infrared |
| fractional bipolar radiofrequency | Active comparator | The abdomen of each patient will be divided in four quadrants around the navel. One quadrant, selected randomly at the subject enrollment, will receive only fractional bipolar radiofrequency , 3 treatments one month apart. Receives: Device: fractional bipolar radiofrequency |
| combined treatment | Active comparator | The abdomen of each patient will be divided in four quadrants around the navel. One quadrant, selected randomly at the subject enrollment, will receive first bipolar radiofrequency potentiated by infrared, followed in the same session by fractional bipolar radiofrequency, 3 treatments one month apart. Receives: Device: bipolar radiofrequency and infrared; Device: fractional bipolar radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of striae volume
The stretch marks in each area will be evaluated with a 3D camera (Antera 3D, Miravex). This will give access to the length, width and depth of each stria. Those measurements will then be compared so as to evaluate each technology.
Measured: before the first treatment, 3 and 6 months after the last treatment. Months 0, 5 and 8
Secondary outcomes (12)
Observation of the skin structure changes with in vivo confocal microscopy
In vivo confocal microscopy acquisitions will be done on all subjects who agree to do so. It is a non-invasive imaging procedure that shows the different structures of the skin (such as collagen fibers and elastin). This will allow us to assess the effect of both technologies, used in monotherapy or combined, on those structures.
Measured: 5 months
Observation of the skin structure changes with in vivo confocal microscopy
In vivo confocal microscopy acquisitions will be done on all subjects who agree to do so. It is a non-invasive imaging procedure that shows the different structures of the skin (such as collagen fibers and elastin). This will allow us to assess the effect of both technologies, used in monotherapy or combined, on those structures.
Measured: 8 months
Observation of the skin structure changes by histology
For four patients, who previously agreed to do so, 3 biopsies will be done (one on each quadrant that will receive a treatment) before any treatment and at the 6 month follow-up session. They will be analyzed in the anatomopathology laboratory of the Archet II hospital. It will show the entire dermal and epidermal evolution after each type of treatment.
Measured: 8 months
Pain assessment
Pain will be assessed with an analogical visual scale.
Measured: 1 month
Pain assessment
Pain will be assessed with an analogical visual scale.
Measured: 2 months
Global satisfaction
The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale.
Measured: 1 month
Global satisfaction
The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale.
Measured: 2 months
Double blinded pictures observation
Standardized pictures will be taken at the beginning of each session. Two external doctors will evaluate each picture on a Physician Global Assessment scale, without knowing to which session or to which subject it corresponds.
Measured: 5 months
Double blinded pictures observation
Standardized pictures will be taken at the beginning of each session. Two external doctors will evaluate each picture on a Physician Global Assessment scale, without knowing to which session or to which subject it corresponds.
Measured: 8 months
global satisfaction
The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale.
Measured: 5 months
Global satisfaction
The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale.
Measured: 8 months
Pain assessment
Pain will be assessed with an analogical visual scale.
Measured: first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StriaeStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Candela France
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thierry Passeron, Pr, Principal investigator, Hopital Archet II, service de Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788748
- Sponsor's protocol ID
- PRB-E2VER02
- Other IDs
- 2012-A01427-36, 12.084
- Status last verified
- Dec 2013
- First submitted
- 5 Feb 2013
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fractional Bipolar Radiofrequency, and Bipolar Radiofrequency Potentiated by Infrared, in Monotherapy or Combined, for the Treatment of Striae
- ClinicalTrials.gov ID
- NCT01788748
- Acronym / sponsor ID
- PRB-E2VER02
- Conditions
- Striae
- Keywords
- fractional, bipolar, radiofrequency, striae, infrared, combined
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Candela FranceIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 11 Feb 2013 (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.
This is an interventional open prospective randomized study, done in two sites.
The main purpose of this study is to evaluate the efficacy of the combination of bipolar radiofrequency potentiated by an infrared light followed by fractional bipolar radiofrequency for the treatment of striae on the abdomen.
In order to have a more complete and accurate study, each technology will also be evaluated separately. This will allow the comparison of the effect of each treatment, in monotherapy or combined.
Detailed description
Stria is a very common condition that affects psychologically and aesthetically a lot of patients. It is a linear atrophic scar. So, to be treated, it needs to have both a superficial and a deep impact.
Several technologies have already been tested for this indication, but none of them have been proved at the same time effective and without a high risk of side effects for all skin types. As radiofrequency is an electrical current, it is not absorbed and does not see melanin. So it can be used on all skin types.
When using fractional bipolar radiofrequency, the current goes from small electrodes to return electrodes. Around the small electrodes appear some epidermal ablation, coagulation and deeper thermal damage. This means it has a superficial and a deep effect.
Using infrared combined with bipolar radiofrequency allows the infrared to pre-heat the skin so as to help the radiofrequency to go deeper in the skin more easily. This has a deep effect in the dermis.
In this study, both technologies will be used. At least 20 patients will be treated in two different sites.
The abdomen of each patient will be divided in four quadrants around the navel. Each quadrant will receive a total of three treatments one month apart:
- One quadrant will be the control (no treatment will be done)
- One quadrant will receive each time only bipolar radiofrequency potentiated by infrared
- One quadrant will receive each time only fractional bipolar radiofrequency
- One quadrant will receive each time first bipolar radiofrequency potentiated by infrared, followed in the same session by fractional bipolar radiofrequency.
The choice of the treatment for each area will be randomized at the enrollment of the patient in the study.
There will be two follow-up sessions 3 and 6 months after the last treatment.
The evaluation will be done mainly by 3D acquisitions. This will allow measuring the length, width and depth of the striae and evaluating their evolution after the treatment.
Some patients, if they agree, will also have in vivo confocal microscopy before the first treatment and 6 months after the last one. This will give more information on the collagen and elastin changes.
Four patients, who accept it, will have biopsies performed before the first treatment and 6 months after the last one to also show the evolution of the skin structure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bipolar radiofrequency and infrared | Active comparator | Device: bipolar radiofrequency and infraredThe abdomen of each patient will be divided in four quadrants around the navel. One quadrant, selected randomly at the subject enrollment, will receive only bipolar radiofrequency potentiated by infrared, 3 treatments one month apart. |
| fractional bipolar radiofrequency | Active comparator | Device: fractional bipolar radiofrequencyThe abdomen of each patient will be divided in four quadrants around the navel. One quadrant, selected randomly at the subject enrollment, will receive only fractional bipolar radiofrequency , 3 treatments one month apart. |
| combined treatment | Active comparator | Device: bipolar radiofrequency and infrared, Device: fractional bipolar radiofrequencyThe abdomen of each patient will be divided in four quadrants around the navel. One quadrant, selected randomly at the subject enrollment, will receive first bipolar radiofrequency potentiated by infrared, followed in the same session by fractional bipolar radiofrequency, 3 treatments one month apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subject over 18 years old, with striae on all the abdomen (white or red)
- Consent form signed by subjects
- Affiliation to social security
Key exclusion criteria (15 listed)
- Electrical implants (pace maker, defibrillator) or superficial metallic implants (gold thread…)
- Pregnant woman
- Woman who can procreate without using an effective birth control
- Deficient immune system due to immunosuppressive diseases such as AIDS or HIV, or use of immunosuppressive drugs,
- Stretch marks resulting from treatment with steroids,
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 |
|---|---|---|
| bipolar radiofrequency and infraredAlso: Applicator Sublime on the platform eTwo | Device | bipolar radiofrequency and infrared, combined treatment |
| fractional bipolar radiofrequencyAlso: applicator Sublative, platform eTwo | Device | combined treatment, fractional bipolar radiofrequency |
Primary outcome
Change of striae volume
Time frame: before the first treatment, 3 and 6 months after the last treatment. Months 0, 5 and 8
The stretch marks in each area will be evaluated with a 3D camera (Antera 3D, Miravex). This will give access to the length, width and depth of each stria. Those measurements will then be compared so as to evaluate each technology.
12 secondary outcomes
Observation of the skin structure changes with in vivo confocal microscopy
Time frame: 5 months
Observation of the skin structure changes with in vivo confocal microscopy
Time frame: 8 months
Observation of the skin structure changes by histology
Time frame: 8 months
Pain assessment
Time frame: 1 month
Pain assessment
Time frame: 2 months
Global satisfaction
Time frame: 1 month
Global satisfaction
Time frame: 2 months
Double blinded pictures observation
Time frame: 5 months
Double blinded pictures observation
Time frame: 8 months
global satisfaction
Time frame: 5 months
Global satisfaction
Time frame: 8 months
Pain assessment
Time frame: first day
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 31 Dec 2013.
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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.
Thierry Passeron, Pr principal investigator
Hopital Archet II, service de Dermatologie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bipolar radiofrequency and infrared and fractional bipolar radiofrequency in people with Striae, run by Candela France at 2 sites in France.
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 15 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 31 Dec 2013. 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 France. 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?
Change of striae volume (time frame: before the first treatment, 3 and 6 months after the last treatment. Months 0, 5 and 8). 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 31 Dec 2013.