The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa: A Randomized, Double Blinded, Placebo Controlled, Cross-over Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage change of area of the wound from visit to visit, estimated from the longest length and width of up to three target chronic wounds
研究概览
简要总结
The purpose of this study is to assess the efficacy of trimethoprim in promoting wound healing and decreasing blister formation in patients with Epidermolysis Bullosa.
详细描述
Epidermolysis Bullosa (EB) comprises a series of hereditary disorders characterized by fragility of the skin and mucous membranes and the tendency of the skin to blister in response to minor friction or trauma. The care of patients with EB is a complex task that has to be carried out by a multi-professional team. In the absence of a cure, the goal of therapy is the prevention and healing of chronic wounds.
In patients with EB, chronic inflammation interferes with proper wound healing. One treatment option is the use of anti-inflammatory antimicrobial agents, such as trimethoprim, to hasten wound healing and decrease blister formation. This treatment may lead to decreased pain and improvement of the quality of life for these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Day 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients younger than 20 years of age
- •Diagnosis of Recessive Dystrophic Epidermis Bullosa (RDEB)or Junctional Epidermis Bullosa (JEB)
- •Signed consent/assent form
排除标准
- •Previous known allergy or intolerance to trimethoprim
研究组 & 干预措施
2
干预措施: Trimethoprim (Drug)
1
干预措施: Trimethoprim (Drug)
结局指标
主要结局
Percentage change of area of the wound from visit to visit, estimated from the longest length and width of up to three target chronic wounds
时间窗: At 2 months, 3 months and 5 months after baseline visit
次要结局
- Qualitative wound score(At 2 months, 3 months and 5 months after baseline visit)
- Number of infections that require systemic antibiotics(6 months)
- Total number of blisters at each visit(At 2 months, 3 months and 5 months after baseline visit)
- Parent/patient/physician perception of improvement, assessed with a visual analog scale at each visit(At 2 months, 3 months and 5 months after baseline visit)
- Total number of opened areas at each visit(At 2 months, 3 months and 5 months after baseline visit)
- Quality of life, assessed by the Children's Dermatology Life Quality Index (CDLQI) and the Cardiff Wound Impact Schedule(At 2 months, 3 months and 5 months after baseline visit)
研究者
Elena Pope
Staff Physician
The Hospital for Sick Children