Microneedling for Dermatoporosis
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 主要终点
- Skin thickness
研究概览
简要总结
We hypothesize that a series of treatments with a microneedling protocol will lead to increased dermal thickness as measured by biopsy, ultrasound, and skin calipometry; an improvement in dermatology-related quality of life; and a reduction in the number of ecchymoses and skin tears, of the research subjects.
详细描述
Dermatoporosis is a common condition, affecting between 30-37% of the population greater than age 65. It may lead to easy bruising, skin tearing, infections, and scars.
The pathogenesis of dermatoporosis involves decreased expression of collagen I, collagen III, and collagen IV; upregulation of matrix metalloproteinases 1, 2, and 3; downregulation of issue inhibitor of matrix metalloprotein I; loss of elastic tissue; defective fibroblast synthesis of collagen; and loss of hyaluronic acid.
Microneedling, also known as percutaneous collagen induction therapy, is a safe, established technique for treatment of acne scarring, rhytides, cellulite, and improvement of skin texture.
Microneedling has been demonstrated to stimulate growth factor release and increase dermal collagen and elastic fibers. It is effective in improving facial laxity, acne scarring, and facial rhytides.
Microneedling is safe and well tolerated. Expected adverse events include bleeding and oozing of the skin surface, redness, swelling, and peeling. Reported complications include post-inflammatory pigmentary changes, granulomatous reactions and systemic hypersensitivity reactions.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients will be eligible for inclusion in the study if they are age 60 or older and have dermatoporosis of the dorsal forearms as defined by any or all of the following: white pseudoscars, senile purpura, or skin atrophy.
排除标准
- •Exclusion criteria: Patients with liver disease, heart disease, active infection, keloid predisposition, immunosuppression, genetic predisposition to poor wound healing, active cancer in the treatment area, bleeding disorders, pregnancy or nursing, taking the medication isotretinoin, with open wounds, sores or irritated skin in the treatment area, allergy to stainless steel or anesthetics, or skin phototype 4 or greater will be excluded from the study.
结局指标
主要结局
Skin thickness
时间窗: one year
Thickness of skin as measured by skin biopsy
Skin thickness ultrasound
时间窗: 6 months
Thickness of skin as measured by ultrasound
次要结局
- Dermatology-related quality of life(six months and one year)
- Number of ecchymoses(six months and one year)