NCT00757315Unknown不适用
Prospective, Controlled Study of the Efficacy of NdYag for Acne Keloidalis Nuchae
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- reduction in severity of AKN as measured by a novel AKN severity scoring system which incorporates number of lesions, size of lesions, type of lesions and associated inflammation.
研究概览
简要总结
Acne Keloidalis Nuchae (AKN) is a long standing hair follicle disease with bumps and scars on the skin of the back of the head and neck. The purpose of this new study is to determine how well a hair removal laser (NdYag Laser) works in treating AKN.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For inclusion, the subject must:
- •Be at least 18 years old
- •Be otherwise healthy
- •Have a diagnosis of AKN with at least 10 papules/pustules and/or a non-keloidal plaque > 7 cm2 in area.
排除标准
- •Subject must not:
- •Have AKN with a keloidal plaque >3 cm in length
- •Be using any other medications or undergoing any other procedures for the treatment of AKN
- •Have used any topical medications or undergone any procedures for the treatments of AKN within two weeks of study enrollment
- •Have used any oral medications for AKN within 4 weeks of study enrollment:
- •Have serious, uncontrolled medical conditions
- •Be pregnant at any time during the study.
研究组 & 干预措施
1
Experimental
干预措施: NdYag Laser(hair removal laser) plus topical corticosteroid (Device)
2
Active Comparator
干预措施: Topical corticosteroid alone (Drug)
结局指标
主要结局
reduction in severity of AKN as measured by a novel AKN severity scoring system which incorporates number of lesions, size of lesions, type of lesions and associated inflammation.
时间窗: 6 months
次要结局
- Treatment tolerability as measured by 0 to 10 pain scale(6 months)
- treatment safety(6 months)
研究者
Iltefat Hamzavi
Dermatologist
Henry Ford Health System
研究点 (1)
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