Combined Trichlotoaceticacid and Microneedle Versus Trichlroacetic Acid Alone in the Treatment of Melasma
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- [mMASI] Scoring before and After last session will be done by 3 months
研究概览
简要总结
Melasma is an acquired disorder of hyperpigmentation characterised by blotchy, light-to-dark brown macules distributed symmetrically on the sun-exposed parts of the body.
Although many factors have been proposed to have a role in pathogenesis, the exact ethology is yet to be understood. The most commonly identifiable risk factors include ultraviolet radiation, genetic predisposition, pregnancy, oral contraceptives, thyroid disease and drugs like antiepileptic. The excessive pigmentation has been attributed to both melanocytosis (increased number of melanocytes) as well as melano genesis (excess production of melanin) as confirmed in a histopathological study on Asian patients.] Furthermore, a vascular component has also been proposed to play a role in the pathogenesis of melisma. Kim et al. have found that lesion melasma skin had greater expression of the vascular endothelial growth factor in keratinocytes compared to nearby nonlesional skin.
详细描述
As regards management, the therapeutic options range from photoprotection, topical hypopigmenting agents, chemical peels and lasers. There are variety of less-tried systemic agents like fish oil, green tea and . Although no single agent has proved to be effective for all patients, a combination of two or three agents is often tried to achieve optimum results.
Chemical peeling is the application of a chemical agent to the skin, which causes the controlled destruction of a part or of the entire epidermis, with or without the dermis, leading to exfoliation and removal of superficial lesions, followed by the regeneration of new epidermal and dermal tissues.
Chemical peels are a well-known modality of treatment for melasma. The basic mechanism of the action of chemical peels in melasma is the removal of unwanted melanin by causing a controlled chemical burn to the skin.
Trichlroacetic acid peeling has been the gold standard in chemical peeling for many decades.
For superficial peels Trichlroacetic acid 10% to 25% are used. some authors consider up to 35% Trichlroacetic acid as also a superficial.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sex will be included Age range from 18- 50 yrs.' old Patients with realistic expectations.
排除标准
- •patients taking oral contraceptive pills. patients with history of polycystic ovary. pregnant and lactating females. patients with active infection. patients on isotretinoin. patients with history of keloids,or hypertrophic scars.
结局指标
主要结局
[mMASI] Scoring before and After last session will be done by 3 months
时间窗: 3 months after last session
before x100. Clinical efficacy was categorized into : Excellent response: if morethan 75%fall in \[mMASI\] score. Very good response:if 50-75%fall in \]mMASI\[score . Good respone: if 25-50%fall in \]mMASI\[score. Poor response: if less25%fall in mMASIscore. No response: when there was no change in \[mMASI\] score at the end of the therapy. Efficacy of the treatment =(mMASIscorebefor -mMASIscoreafter)/mMASIscore before x100. Clinical efficacy was categorized into : Excellent response: if morethan 75%fall in \[mMASI\] score. Very goodresponse:if 50-75%fall in \]mMASI\[score . Good respone: if 25-50%fall in \]mMASI\[score. Poor response: if less25%fall in mMASIscore. No response: when there was no c
Scoring of the patients according to modified melasma are abd severity index [mMASI] Scoring before and After last session will be done by 1 month
时间窗: 1 month after last session
Efficacy of the treatment =(mMASIscorebefor -mMASIscoreafter)/mMASIscore before x100. Clinical efficacy was categorized into : Excellent response: if morethan 75%fall in \[mMASI\] score. Very good response:if 50-75%fall in \]mMASI\[score . Good respone: if 25-50%fall in \]mMASI\[score. Poor response: if less25%fall in mMASIscore. No response: when there was no change in \[mMASI\] score at the end of the therapy. Efficacy of the treatment =(mMASIscorebefor -mMASIscoreafter)/mMASIscore before x100. Clinical efficacy was categorized into : Excellent response: if morethan 75%fall in \[mMASI\] score. Very goodresponse:if 50-75%fall in \]mMASI\[score . Good respone: if 25-50%fall in \]mMASI\[score. Poor response: if less25%fall in mMASIscore. No response: when there was no change in \[mMASI\] score at the end of the therapy.
次要结局
未报告次要终点
研究者
Safaa Hamed
Principal investigator
Assiut University