Human Subject Research Ethics Committee, 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- The degree of improvement in lesion thickness
研究概览
简要总结
The treatment of chronic inflammatory skin diseases is a difficult point in clinical diseases, which mainly include patients with pathological scars, sarcoidosis and chronic eczema. Chronic nodular lesions and long-term itching symptoms bring great physical and mental pain to patients.
Long-term repeated treatments are required. At present, the most commonly used treatment is intralesional injection of glucocorticoids. Long-term glucocorticoid injections have some side effects, including pain, hypopigmentation, skin atrophy, pigmentation, telangiectasia and menstrual disorders in women. There are a large number of clinical patients who still lack safe and effective drugs, including children, pregnant women, patients with weakened or defective immunity, and even patients with mild inflammatory skin diseases with mainly itching symptoms.
The systemic and topical application of antihistamine drugs provides new ideas for the treatment of inflammatory skin. As the most commonly used clinical antihistamine, chlorpheniramine has a long history in the treatment of allergic diseases and can improve the body's inflammatory state. At the same time, the drug has high safety and is suitable for children and pregnant women, or patients with underlying diseases such as hypertension, diabetes, and immunodeficiency diseases.
详细描述
At present, there are more and more reports about the application of antihistamines to the treatment of pathological scars. Exposing fibroblasts from normal skin and keloids to the antihistamine diphenhydramine can inhibit the growth of keloid fibroblasts . Based on the existing research foundation in the field and the results of our previous laboratory experiments, we hypothesize that intralesional injection of chlorpheniramine can improve the pruritus symptoms and the severity of skin lesions in inflammatory skin diseases, and can be used as a new application of traditional medicine.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Antihistamine treatment group
Chlorpheniramine, the concentration is 10mg/ml per unit point, the highest dose is 1ml
干预措施: Chlorpheniramine-Codeine (Drug)
结局指标
主要结局
The degree of improvement in lesion thickness
时间窗: 1 year
After a treatment cycle of the lesion, the degree of improvement in the thickness of the lesion is graded according to the total score of the patient's self-evaluation and the doctor's evaluation
次要结局
未报告次要终点
