Treatment of Atrofic Striae With Percutaneous Collagen Induction Therapy Versus Fractional Nonablative Laser: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Clinical response in abdominal alba striae after the therapies
研究概览
简要总结
As atrophic striae are common dermatological conditions. Various therapeutic modalities have been employed in the treatment of striae distensae, mainly in striae rubra. There are few studies that include the treatment of striae alba.
The non-ablative fractionated laser and, more recently, microneedling are two distinct treatments, but they are widely used in dermatologist practice.
The present randomized clinical trial is aimed at evaluating and evaluating the response of microneedle and fractional non-ablative laser Nd-yap 1340 in the treatment of abdominal striae alba.
详细描述
Twenty patients will be treated at the dermatologic clinic of the Hospital de Clínicas de Porto Alegre (HCPA). Each patient will be treated with laser and microneedle at the same time, being applied a therapeutic procedure in each part of the abdomen (divided lengthwise and in equal parts). Each part of the abdomen will be randomized for the treatment of laser or microneedling with the help of the Excel 2013 program. The investigator responsible for procedures and patients are the only ones with unblinded assessment in relation to the side of each treatment. There will be 5 sessions with monthly intervals of the proposed treatments. The ND-yap 1340-nm laser will be used, and in the other segment of the abdomen, the dermaroller 2.5 mm was applied. Photographic records of patients will be performed at pre-treatment and 1 month after the third and fifth sessions. The questionnaires will be applied to assess the quality of life in dermatology DLQI (Dermatology Life Quality Index). Two independent and blind evaluators for the type of treatment will apply in the Global Aesthetic Scale (GAIS) in the evaluation of photographic records. Cutaneous biopsies for histopathological evaluation will be performed with a punch 3 mm of each part of the abdomen at pretreatment. Two experienced pathologists will evaluate the measurements of the epidermis and the collagen and elastic fibers of the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Clinical evaluators will evaluate the photos after the treatments blindly for which type of treatment applied.
Evaluators of skin biopsies will be blinded to what type of treatment is applied and for pre-treatment and post-treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients,
- •age 18 and over;
- •presenting with abdominal striae rubra diagnosed after clinical examination;
- •patients with weight stability in the last four months;
- •patients with Fitzpatrick III or IV phototype.
排除标准
- •pregnant women;
- •childbirth for less than 12 months;
- •history of keloid scars;
- •presence of localized or systemic infection;
- •presence of immunosuppression;
- •use of photosensitizing medications;
- •use of systemic steroids;
- •use of oral isotretinoin in the last 12 months;
- •history of diseases of collagen or elastic fibers;
- •hypersensitivity to infiltrative or topical anesthetics;
- •patients who have been treated for striae distensae in the last year;
- •presence of sun exposure during the study.
研究组 & 干预措施
Nd-Yap 1340nm laser
The randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of Nd-yap 1340nm laser.
干预措施: Nd-Yap 1340nm laser (Device)
Microneedling
The randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of dermaroller 2,5mm.
干预措施: Microneedling (Device)
结局指标
主要结局
Clinical response in abdominal alba striae after the therapies
时间窗: 6 months
Clinical response to microneedle treatment and nonablative fractional laser treatment without abdominal alba striae (GAIS scale). The GAIS scale is a non-numerical scale divided into 5 categories of clinical response: very much improved, much improved, improved, no changed and worse.
次要结局
- The tolerability and incidence of adverse effects during the therapies(5 months)
- Clinical response to microneedle treatment and nonablative fractional laser treatment(4 months)
- Histopatological response in abdominal striae alba after the therapies(6 months)
- The impact on the quality of life provided by the striae distensae(6 months)