Evaluation of Fractional Bipolar Radiofrequency, and Bipolar Radiofrequency Potentiated by Infrared, in Monotherapy or Combined, for the Treatment of Striae
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Change of striae volume
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change of striae volume
时间窗: 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.
次要结局
- 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(first day)
- Global satisfaction(8 months)
- Double blinded pictures observation(8 months)
- global satisfaction(5 months)