The Effect of Preceding Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or With NB-UVB in the Treatment of Stable Generalized Vitiligo
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 主要终点
- 1- Re-pigmentation : that will be subjectively rated with a previously reported scoring system (Ghiya et al., 2016).
研究概览
简要总结
Vitiligo is an acquired disorder of the skin and mucous membranes characterized by well circumscribed depigmented macules and patches that occur secondary to selective destruction of melanocytes (Zhang et al., 2009).
Generalized vitiligo is the most common clinical presentation and often involves the face and acral regions (Alikhan et al., 2011).
详细描述
Combined vitiligo treatments have been found to be superior to monotherapies regarding efficacy, early response and safety (Kandaswamy et al., 2013).
Fractionated lasers represent a new modality for skin resurfacing based on the theory of fractional photothermolysis introduced by Manstein et al (2004). These lasers were shown to be efficient in treating facial photo aging changes as well as scars, and have an improved safety and recovery profile compared with traditional CO2 laser resurfacing. Fractionated lasers do not ablate the entire epidermis and thereafter leave intact skin between coagulated necrotic columns. This characteristic facilitates the skin healing process (Bogdan et al., 2010)
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
- None
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with stable vitiligo
- •nonsegmental vitiligo will be recruited
- •A patient reporting no new lesions, no progression of existing lesions, and absence of Koebner phenomenon during the previous year
排除标准
- •Patients with active infection.
- •Reported histories of koebnerization.
- •History of keloid formation or hypertrophic scars.
- •Pregnant or lactating females.
- •Bleeding tendency.
研究组 & 干预措施
Group A (Tacrolimus group):
fractional CO2 laser therapy and Tacrolimus ointment 1
干预措施: Tacrolimus ointment (Drug)
Group B (Calcipotriol group):
fractional CO2 laser therapy and Calcipotriol ointment
干预措施: calcipotriol ointment (Drug)
Group C (NB-UVB group):
fractional CO2 laser therapy and NB-UVB twice weekly
干预措施: NB-UVB (Drug)
结局指标
主要结局
1- Re-pigmentation : that will be subjectively rated with a previously reported scoring system (Ghiya et al., 2016).
时间窗: up to 3 months
G0, \< 25% repigmentation (poor) * G1, 25-50% repigmentation (fair) * G2, 50-75% repigmentation (good) * G3 \> 75% repigmentation (excellent).
次要结局
- The VASI percent change(every month for 3 months)
研究者
Yasmin Mostafa Tawfik
clinical professor
Assiut University