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
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Aesthetics | Bordeaux | |
France | CHU Archet II, Service de Dermatologie | Nice |
Lead Sponsor | Collaborator |
---|---|
Candela France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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. | 5 months | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | Pain assessment | Pain will be assessed with an analogical visual scale. | 1 month | No |
Secondary | Pain assessment | Pain will be assessed with an analogical visual scale. | 2 months | No |
Secondary | Global satisfaction | The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale. | 1 month | No |
Secondary | Global satisfaction | The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale. | 2 months | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | global satisfaction | The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale. | 5 months | No |
Secondary | Global satisfaction | The global satisfaction of both the subject and the investigator will be assessed with an analogical visual scale. | 8 months | No |
Secondary | Pain assessment | Pain will be assessed with an analogical visual scale. | first day | No |
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