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Evaluation of Fractional Bipolar Radiofrequency for the Treatment of Striae

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ClinicalTrials.gov Identifier: NCT01788748
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):
Candela France

Brief 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.


Condition or disease Intervention/treatment Phase
Striae Device: bipolar radiofrequency and infrared Device: fractional bipolar radiofrequency Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Fractional Bipolar Radiofrequency, and Bipolar Radiofrequency Potentiated by Infrared, in Monotherapy or Combined, for the Treatment of Striae
Study Start Date : February 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Active Comparator: bipolar radiofrequency and infrared
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.
Device: bipolar radiofrequency and infrared
Other Name: Applicator Sublime on the platform eTwo

Active Comparator: fractional bipolar radiofrequency
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.
Device: fractional bipolar radiofrequency
Other Name: applicator Sublative, platform eTwo

Active Comparator: combined treatment
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.
Device: bipolar radiofrequency and infrared
Other Name: Applicator Sublime on the platform eTwo

Device: fractional bipolar radiofrequency
Other Name: applicator Sublative, platform eTwo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Observation of the skin structure changes with in vivo confocal microscopy [ Time Frame: 5 months ]
    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.

  2. Observation of the skin structure changes with in vivo confocal microscopy [ Time Frame: 8 months ]
    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.

  3. Observation of the skin structure changes by histology [ Time Frame: 8 months ]
    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.

  4. Pain assessment [ Time Frame: 1 month ]
    Pain will be assessed with an analogical visual scale.

  5. Pain assessment [ Time Frame: 2 months ]
    Pain will be assessed with an analogical visual scale.

  6. Global satisfaction [ Time Frame: 1 month ]
    The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale.

  7. Global satisfaction [ Time Frame: 2 months ]
    The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale.

  8. Double blinded pictures observation [ Time Frame: 5 months ]
    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.

  9. Double blinded pictures observation [ Time Frame: 8 months ]
    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.

  10. global satisfaction [ Time Frame: 5 months ]
    The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale.

  11. Global satisfaction [ Time Frame: 8 months ]
    The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale.

  12. Pain assessment [ Time Frame: first day ]
    Pain will be assessed with an analogical visual scale.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788748


Locations
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France
Aesthetics
Bordeaux, France, 33200
CHU Archet II, Service de Dermatologie
Nice, France, 06200
Sponsors and Collaborators
Candela France
Investigators
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Principal Investigator: Thierry Passeron, Pr Hopital Archet II, service de Dermatologie

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Responsible Party: Candela France
ClinicalTrials.gov Identifier: NCT01788748     History of Changes
Other Study ID Numbers: PRB-E2VER02
2012-A01427-36 ( Other Identifier: ANSM (French health committee) )
12.084 ( Other Identifier: CPP Sud Méditerranée V (ethics committee) )
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013

Keywords provided by Candela France:
fractional
bipolar
radiofrequency
striae
infrared
combined

Additional relevant MeSH terms:
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Striae Distensae
Skin Manifestations
Signs and Symptoms