A Comparative Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Limited CLASI
研究概览
简要总结
This study aims to compare the efficacy of 532nm Potassium Titanyl Phosphate (KTP) laser and 1064 nm Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) laser as adjuncts to topical corticosteroids in the treatment of cutaneous lupus erythematosus versus topical corticosteroids alone.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adult 18 years of age or older
- •Ability to rate level of pain
- •Ability to rate visual satisfaction
- •At least 2 active lesions of CLE
排除标准
- •New or change in systemic medication for cutaneous lupus in past 6 months
- •Allergy to triamcinolone or betamethasone dipropionate cream
- •Pregnancy
- •Currently a prisoner
- •Unable to read and speak English since consent will only be available in English
研究组 & 干预措施
532nm laser and topical corticosteroid
532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.
干预措施: 532nm laser (Device)
532nm laser and topical corticosteroid
532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.
干预措施: Topical corticosteroid (Drug)
1064nm laser and topical corticosteroid
1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.
干预措施: 1064nm laser (Device)
1064nm laser and topical corticosteroid
1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.
干预措施: Topical corticosteroid (Drug)
Topical corticosteroid alone
Topical corticosteroid is applied to the patient's lesion.
干预措施: Topical corticosteroid (Drug)
结局指标
主要结局
Limited CLASI
时间窗: 2 Months
The investigators are using a limited Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) scoring system to classify specific lesions the investigators are measuring. The total limited CLASI reflects the sum of both active and damage CLASI, resulting in a score ranging from 0 to 8. A higher score indicates more severe disease. Score is assessed by the investigators. The limited active CLASI for a lesion will include the following: * Erythema (ranging from 0 = absent to 3 = dark red/purple) * Scale/Hypertrophy (ranging from 0 = absent to 2 = verrucous/ hypertrophic) * The addition of these scores result in a total limited active CLASI score of the studied lesion, ranging from 0 to 5. The limited damage CLASI for a lesion will include the following: * Dyspigmentation (0 = absent or 1 = present) * Scarring/Atrophy/Panniculitis (ranging from 0 = absent to 2 = severely atrophic scarring or panniculitis). * The addition of these scores result in a
VAS for Appearance
时间窗: 2 Months
The investigators are using a VAS (visual analog scale) to measure patient assessment of the appearance of the lesion. The scale ranges from 0-10, with 10 being very satisfied and 0 being no satisfaction at all. A score of 0 will represent a cosmetically fully unsatisfactory result and 10 will represent cosmetically excellent result.
VAS for Pain
时间窗: 1 Month
The investigators are using a VAS (visual analog scale) to assess pain of the laser treatment. The participant rates the pain of the laser treatment. The scale ranges from 0 (no pain) to 10(worse pain). A score of 0 will represent absence of pain and 10 will represent maximal pain.
次要结局
未报告次要终点
研究者
David Weinstein
Assistant Professor of Dermatology
University of Central Florida