NCT01720056终止4 期
Assessment of Verapamil as an Adjunct for Prevention of Keloid Recurrence After Surgical Removal
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Keloid recurrence
研究概览
简要总结
Keloid scarring is a severe cosmetic and painful disease of the skin. The gold standard treatment is yet to be clarified. This randomized clinical pilot study will compare the effects of two local treatments for preventing keloid recurrence after surgical removal; steroid and verapamil.
Study hypothesis: Intralesional therapy with the calcium antagonist verapamil has equal treatment efficacy as steroid injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Patient undergoing surgical removal of keloid
- •Patient 18 years old or greater
- •Length of excisional scar after surgical removal of keloid between 2 and 10 cm
排除标准
- •Keloid in face or hands
- •Pregnancy or lactation
- •Any heart or pulmonary condition
- •Systemic treatment with beta-blockers, ACE-inhibitors or calcium antagonists
- •Systemic corticosteroidal therapy
- •Intralesional steroid treatment within 2 months of surgery to remove keloid
- •Flap surgery
- •Lesions to face, hands and other cosmetically sensitive areas
研究组 & 干预措施
Verapamil
Active Comparator
Verapamil 2.5 mg/mL injection sc intralesionally
干预措施: Verapamil (Drug)
Kenalog 10
Active Comparator
Kenalog 10 mg/mL injection sc intralesionally
干预措施: Kenalog 10 (Drug)
结局指标
主要结局
Keloid recurrence
时间窗: 1 year
次要结局
- Vancouver Scar Scale Score(1 year)
研究者
Fiona M. Wood
Prof. Wood
The University of Western Australia
研究点 (1)
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