Evaluation of Topical Steroids and Surgical Treatment for Idiopathic Granulomatous Mastitis
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- clinical response rate
研究概览
简要总结
This study evaluates the clinical response rate of topical steroids in the treatment of idiopathic granulomatous mastitis in female adults. Half of the participants will receive topical steroid and the other half will receive local wide surgical excision.
详细描述
Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast disease of unknown etiology.It may present with many findings that clinically and radiologically mimic breast cancer.
Although IGM as a disease has been known for nearly four decades, the optimal treatment approach has not been established. Surgical intervention in the form of wide surgical excision was the mainstay of treatment before 1980, and is still performed depending on local expertise and preference.
Currently,surgical treatment and systemic steroid treatment are frequently employed. With the consideration of side effects of longterm systemic (oral) steroid usage, topical steroid without systemic use were assessed and showed satisfactory curative effect. But the data concerning the use of topical steroid therapy are still very limited.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Granulomatous Mastitis
排除标准
- •Breast Carcinoma
研究组 & 干预措施
medical
Hydrocortisone butyrate cream(0.1%) was applied to the breast by the patient twice a day on alternate days until the termination of treatment.
干预措施: Hydrocortisone Butyrate (Drug)
surgical
lesion extended excision
干预措施: extended excision (Procedure)
结局指标
主要结局
clinical response rate
时间窗: six months
The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.
次要结局
- granulomatous mastitis recurrence(two years)