Evaluation of Fractional Bipolar Radiofrequency for the Treatment of Striae

Striae Clinical Trial

Official title: Evaluation of Fractional Bipolar Radiofrequency, and Bipolar Radiofrequency Potentiated by Infrared, in Monotherapy or Combined, for the Treatment of Striae

Status Completed

Clinical 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.

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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Striae
• Striae Distensae

• NCT number: NCT01788748
• Study type: Interventional
• Source: Candela France
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Completion date: November 2013