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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01427-36 | Other Identifier | ANSM (French health committee) | |
| 12.084 | Other Identifier | CPP Sud Méditerranée V (ethics committee) |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bipolar radiofrequency and infrared | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | before the first treatment, 3 and 6 months after the last treatment. Months 0, 5 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry Passeron, Pr | Hopital Archet II, service de Dermatologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aesthetics | Bordeaux | 33200 | France | |||
| CHU Archet II, Service de Dermatologie |
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| ID | Term |
|---|---|
| D057896 | Striae Distensae |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| fractional bipolar radiofrequency | Device |
|
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| 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. | 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. | 8 months |
| Pain assessment | Pain will be assessed with an analogical visual scale. | 1 month |
| Pain assessment | Pain will be assessed with an analogical visual scale. | 2 months |
| Global satisfaction | The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale. | 1 month |
| Global satisfaction | The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale. | 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. | 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. | 8 months |
| global satisfaction | The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale. | 5 months |
| Global satisfaction | The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale. | 8 months |
| Pain assessment | Pain will be assessed with an analogical visual scale. | first day |
| Nice |
| 06200 |
| France |