Effect of Q-switched Nd-YAG laser on the clinical, pigmentary and immunological markers in the patients with lichen planus pigmentosus: A pilot study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Clinical improvement in pigmentation in patients with lichen planus pigmentosus with 6 sessions of Q switched Nd-YAG laser for 3 months at 2-weeks interval.
研究概览
简要总结
Lichen planus pigmentosus (LPP) is a pigmentary disorder characterized by persistent and asymptomatic slate-gray pigmentation over face, neck and flexures. This results in severe cosmetic disability and morbidity. Existing treatment options have shown minimal to nil improvement. The persistent pigmentation is secondary to persistent melanophages in the papillary dermis resistant to medical therapies. Q-switched Nd-YAG laser is known to disrupt the melanin pigment in the dermis via photothermolysis. We plan to undertake this pilot study to evaluate the effect of Q-switched Nd-YAG laser in the management of 10 patients of lichen planus pigmentosus. Six laser sessions will be performed at 2-weekly interval using a low fluence skin toning protocol. Patient and physician assessment of improvement as well as objective measurement of melanin and erythema index will be done at each visit and 2 weeks after the last laser session. Since, there are no proper study available evaluating the effect of Nd-YAG laser in LPP, we also plan to study the laser induced changes in immunological and pigmentary markers pre and post treatment which will be done by analysis of immunohistochemistry and mRNA expression of melanin pigment markers as MART-1, MITF and tyrosinase and macrophage markers as CD68 and CD163. This will be done one hour after the first laser session in five patients and after 2-weeks of last laser session in remaining five patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients presenting with slate-gray hyperpigmented macules over neck, trunk or extremities 2.Histological evaluation showing minimal inflammatory infiltrate with presence of dermal pigment.
排除标准
- •1.The presence of dense inflammatory infiltrate in dermis 2.Age less than 18 years 3.Patients not able to follow-up frequently 4.Patients with active infections, keloidal tendency, clotting abnormalities and serious systemic diseases 5.Pregnant or lactating females.
结局指标
主要结局
Clinical improvement in pigmentation in patients with lichen planus pigmentosus with 6 sessions of Q switched Nd-YAG laser for 3 months at 2-weeks interval.
时间窗: Patient and physician assessment of improvement as well as objective measurement of reduction in melanin pigment will be done at each visit and after 2 weeks of last laser visit
次要结局
- Detailed evaluation of the effect of laser on the dermal melanin pigment and melanophages in these patients. This will be done by comparing the pre and post treatment immunohistochemistry and mRNA expression analysis of MART-1, tyrosinase, MITF, CD68 and CD163.(In five patients, post-treatment analysis done immediately one hour after the first laser session will help in determining the immediate effect of the laser on the destruction of melanophages and melanin. In the remaining five patients, this analysis done 2 weeks after the last laser visit will help in evaluation of long term effect of the laser on these cells.)