Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- hair regrowth
研究概览
简要总结
Systemic Pulse Glucocorticoids have been shown to be effective in widespread Alopecia areata but not the totalis, universalis or ophiasic type. Whether the failure is due to inadequate dosing, inadequate frequency or other factors is a matter of debate. The investigators decided to conduct this study using the oral pulse steroid, however with higher doses and more frequent pulses to patients with severe forms of Alopecia areata.
详细描述
This will be a single-center, prospective, randomized study conducted in King Khalid University Hospital. Patients diagnosed with either Alopecia universalis, Alopecia totalis or Ophiasic alopecia will be included in the study. Patients with contraindications such as diabetes mellitus, peptic ulcer, hypertension, infection, psychosis, heart or kidney disease, endocrine disorders (apart from a subclinical hypothyroidism and autoimmune thyroiditis) will be excluded. Children less than 5 years of age and those who received systemic or topical treatment within the last 4 weeks before enrollment will be also excluded. Those of child bearing potential had to have a negative urine pregnancy test result at baseline visit and should practice a reliable method of contraception throughout the study. 42 eligible patients will be randomly assigned to one of 3 treatment groups. Enrolled patients must provide written informed consent. Institutional review board approval will be obtained.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alopecia Universalis
- •Alopecia Totalis
- •Ophiasic Alopecia
排除标准
- •diabetes mellitus
- •peptic ulcer
- •hypertension
- •infection
- •psychosis
- •heart disease
- •kidney disease
- •endocrine disorders (apart from a subclinical hypothyroidism and autoimmune thyroiditis)
- •received systemic or topical treatment within the last 4 weeks before enrollment
- •pregnancy
研究组 & 干预措施
Group A
will receive pulse treatment for 3 consecutive days once every 2 weeks for 24 weeks
干预措施: methylprednisolone sodium succinate (Drug)
Group B
will receive 2 consecutive daily pulses every 3 weeks for 24 weeks
干预措施: methylprednisolone sodium succinate (Drug)
Group C
will receive 3 consecutive daily pulses every 3 weeks for 24 weeks.
干预措施: methylprednisolone sodium succinate (Drug)
结局指标
主要结局
hair regrowth
时间窗: at 36 weeks of treatment
Photographs of scalp will be taken before treatment and every 2 visits. Analysis of the photographs will be conducted by two independent dermatologists. Primary efficacy measure will be the proportion of responders at 36 weeks.
次要结局
- Safety of the protocol(from the first visit till one year after discontinuation of treatment)
- Factors affect the response to treatment(at 36 weeks)