Evaluation of Fractional Bipolar Radiofrequency for the Treatment of Striae

NCT01788748 | Completed

• 3 other identifiers: PRB-E2VER022012-A01427-3612.084
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Striae

Keywords

fractional; bipolar; radiofrequency; striae; infrared; combined

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Observation of the skin structure changes with in vivo confocal microscopy

  5 months

• Observation of the skin structure changes with in vivo confocal microscopy

  8 months

• Observation of the skin structure changes by histology

  8 months

• Pain assessment

  1 month

• Pain assessment

  2 months

Study Arms (3)

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.

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.

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.

Device: bipolar radiofrequency and infrared; Device: fractional bipolar radiofrequency

Interventions

bipolar radiofrequency and infrared DEVICE

Also known as: Applicator Sublime on the platform eTwo

bipolar radiofrequency and infrared; combined treatment

fractional bipolar radiofrequency DEVICE

Also known as: applicator Sublative, platform eTwo

combined treatment; fractional bipolar radiofrequency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Candela France: lead

Study Sites (2)

Aesthetics

Bordeaux, 33200, France

Location

CHU Archet II, Service de Dermatologie

Nice, 06200, France

Location

MeSH Terms

Conditions

Striae Distensae

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thierry Passeron, Pr

  Hopital Archet II, service de Dermatologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 11, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 31, 2013

Record last verified: 2013-12

Locations

FR (2)