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Evaluation of Fractional Bipolar Radiofrequency for the Treatment of Striae

Primary Purpose

Striae

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bipolar radiofrequency and infrared
fractional bipolar radiofrequency
Sponsored by
Candela France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Striae focused on measuring fractional, bipolar, radiofrequency, striae, infrared, combined

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Aesthetics
  • CHU Archet II, Service de Dermatologie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

bipolar radiofrequency and infrared

fractional bipolar radiofrequency

combined treatment

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Pain assessment
Pain will be assessed with an analogical visual scale.
Pain assessment
Pain will be assessed with an analogical visual scale.
Global satisfaction
The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale.
Global satisfaction
The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale.
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.
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.
global satisfaction
The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale.
Global satisfaction
The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale.
Pain assessment
Pain will be assessed with an analogical visual scale.

Full Information

First Posted
February 5, 2013
Last Updated
December 30, 2013
Sponsor
Candela France
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1. Study Identification

Unique Protocol Identification Number
NCT01788748
Brief Title
Evaluation of Fractional Bipolar Radiofrequency for the Treatment of Striae
Official Title
Evaluation of Fractional Bipolar Radiofrequency, and Bipolar Radiofrequency Potentiated by Infrared, in Monotherapy or Combined, for the Treatment of Striae
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Candela France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Striae
Keywords
fractional, bipolar, radiofrequency, striae, infrared, combined

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bipolar radiofrequency and infrared
Arm Type
Active Comparator
Arm Description
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.
Arm Title
fractional bipolar radiofrequency
Arm Type
Active Comparator
Arm Description
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.
Arm Title
combined treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
bipolar radiofrequency and infrared
Other Intervention Name(s)
Applicator Sublime on the platform eTwo
Intervention Type
Device
Intervention Name(s)
fractional bipolar radiofrequency
Other Intervention Name(s)
applicator Sublative, platform eTwo
Primary Outcome Measure Information:
Title
Change of striae volume
Description
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.
Time Frame
before the first treatment, 3 and 6 months after the last treatment. Months 0, 5 and 8
Secondary Outcome Measure Information:
Title
Observation of the skin structure changes with in vivo confocal microscopy
Description
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.
Time Frame
5 months
Title
Observation of the skin structure changes with in vivo confocal microscopy
Description
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.
Time Frame
8 months
Title
Observation of the skin structure changes by histology
Description
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.
Time Frame
8 months
Title
Pain assessment
Description
Pain will be assessed with an analogical visual scale.
Time Frame
1 month
Title
Pain assessment
Description
Pain will be assessed with an analogical visual scale.
Time Frame
2 months
Title
Global satisfaction
Description
The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale.
Time Frame
1 month
Title
Global satisfaction
Description
The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale.
Time Frame
2 months
Title
Double blinded pictures observation
Description
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.
Time Frame
5 months
Title
Double blinded pictures observation
Description
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.
Time Frame
8 months
Title
global satisfaction
Description
The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale.
Time Frame
5 months
Title
Global satisfaction
Description
The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale.
Time Frame
8 months
Title
Pain assessment
Description
Pain will be assessed with an analogical visual scale.
Time Frame
first day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Passeron, Pr
Organizational Affiliation
Hopital Archet II, service de Dermatologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aesthetics
City
Bordeaux
ZIP/Postal Code
33200
Country
France
Facility Name
CHU Archet II, Service de Dermatologie
City
Nice
ZIP/Postal Code
06200
Country
France

12. IPD Sharing Statement

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Evaluation of Fractional Bipolar Radiofrequency for the Treatment of Striae

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