Comparison of the Effectiveness of Brightening Creams vs Laser Therapy (QS Nd:YAG 1064nm Laser) in Skin Hyperpigmentation After Sclerotherapy by Objective Measurement: A Randomized Controlled Monocentric Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Equivalence of laser and cream in reducing post-sclerotherapy hyperpigmentation as assessed by SHI
研究概览
简要总结
The treatment of leg veins and varicosis with sclerotherapy is one of the most frequently performed medical intervention in the western world. The most common local side effects of this treatment are hyperpigmentations caused by hemosiderin deposition in the skin as well as post inflammatory hyperpigmentation.
Although skin hyperpigmentation after sclerotherapy is a common over several months up to years lasting side-effect with a strong aesthetic impact, scanty data exist about treatment options.
Quality-Switched (QS) lasers are efficient in the removal of exogenous and endogenous pigments, such as tattoos as well as epidermal and dermal melanin deposits. The laser light is absorbed by pigment particles, leading to a fragmentation of these particles by a photothermal and photoacoustic effect. Smaller particles can be then phagocyted by macrophages, and transported via the lymphatic system into the lymph nodes. Furthermore, the positive effect of QS lasers in the management of cutaneous siderosis in stasis dermatitis and after sclerotherapy has been described in several cases.
Triple cream including hydroquinone, tretinoin and a topical corticosteroid (eg dexamethasone), is the first line therapy in the treatment of post inflammatory hyperpigmentation.
This randomized controlled study aims to evaluate the efficiency of two well-known depigmentation methods (QS laser and triple cream) for treatment of post sclerotherapy hyperpigmentation, compared with a control group performing no treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fitzpatrick skin type I-IV
- •Presence of at least 1 postinflammatory hyperpigmentation after sclerotherapy
排除标准
- •History of adverse events related to short-pulsed laser therapy
- •Pregnant or breast-feeding women
- •Intention to become pregnant during the course of the study
- •History of intolerance or allergic reaction to triple cream or one of its ingredients
- •Prior treatment with parenteral gold therapy
- •Inability to understand the study content
研究组 & 干预措施
Cream
干预措施: Triple cream (Drug)
结局指标
主要结局
Equivalence of laser and cream in reducing post-sclerotherapy hyperpigmentation as assessed by SHI
时间窗: 16 weeks
Equivalence of laser and cream groups in reducing post-sclerotherapy hyperpigmentation as assessed by Skin Hyperpigmentation Index (SHI), ranging from 1 to 4, with higher score indicating a worst hyperpigmentation.
次要结局
- Efficacy of laser and cream in reducing post-sclerotherapy hyperpigmentation compared to control group as assessed by SHI(4, 8, 12, 16 weeks)
- Efficacy of laser and cream in reducing post-sclerotherapy hyperpigmentation compared to control group as assessed by PGA(4, 8, 12, 16 weeks)
- Patient's satisfaction related to laser and cream in reducing post-sclerotherapy hyperpigmentation compared to control group(16 weeks)