Efficacy of Doxycycline in the Treatment of Early Stages of Mycosis Fungoides: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Clinical assessment
研究概览
简要总结
Current study aims at assessing the efficacy of doxycycline as a potential treatment modality for early stages of MF.
详细描述
Objectives
Objective is to evaluate the efficacy of doxycycline in treatment of early stages of mycosis fungoides (IA, IB and IIA) and to assess its apoptotic enhancing effect by studying the expression of BCL2 by the T lymphocytes.
Study Design
Randomized controlled trial
Population of study & disease condition
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (above 18) of either sex with established diagnosis of classic MF
排除标准
- •Any variant of MF other than the classic variant.
- •Advanced stages of classic MF: Stage IIb, III or IV.
- •Pregnant and lactating females.
- •Patients with autoimmune diseases e.g. SLE
- •Patients with solid or hematological malignancies e.g. breast cancer, leukemia, etc.
- •Patients with any contraindications for doxycycline (eg: liver disease, kidney disease, photosensitivity, peptic ulcer or patients receiving systemic retinoids).
- •Patients with any contraindication to phototherapy (eg: any other skin cancers or photosensitivity); or to psoralen (eg: liver disease)
研究组 & 干预措施
Doxycyline
Oral Vibramycin antibiotic100 mg capsule every 12 hours for 3 months
干预措施: Vibramycin (Drug)
Doxycyline
Oral Vibramycin antibiotic100 mg capsule every 12 hours for 3 months
干预措施: Phototherapy (Device)
Phototherapy
UVA+ psoralen 3 sessions per week for 3 months
干预措施: Vibramycin (Drug)
Phototherapy
UVA+ psoralen 3 sessions per week for 3 months
干预措施: Phototherapy (Device)
结局指标
主要结局
Clinical assessment
时间窗: 3 months
Clinical assessment of the extent of the lesions in body surface area
次要结局
- Pathological assessment(3months)
研究者
Hagar El Sayed
Principle investigator
Cairo University