Efficacy of a 585 nm Pulsed Dye Laser (PDL) for the Treatment of Dermatosis Papulosa Nigra, and Compare it to Therapy With Curettage and Electrodesiccation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percent Clearance of All Lesions
研究概览
简要总结
DPN is a disorder among darkly pigmented patients, manifested by small, benign, variants of seborrheic keratoses, predominantly on the face.
The purpose of this study is to determine the efficacy of a 585 nm PDL for the treatment of Dermatosis Papulosa Nigra, and compare it to therapy with curettage (scraping the lesions off) and electrodesiccation (burning the lesions off).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Over 18 years of age.
- •Able to give informed consent.
- •Desires removal of lesions.
- •Willing to come back for six week follow-up.
- •Willing to fill out post operative questionnaire.
- •At least 4 lesions less than 7 mm.
- •Diagnosis of Dermatosis Papulosa Nigra (DPN)
排除标准
- •Less than 18 years of age.
- •Pregnant.
- •Sensitive to laser energy.
- •History of Collagen Vascular Disorders.
- •History of Keloids.
- •History of post inflammatory hyperpigmentation.
- •Incarcerated.
- •Unable to give informed consent.
- •Unable to follow up for post operative evaluation.
- •Unable to complete patient visual analogue scale.
- •Unable to understand consent process or risks.
- •Unable to accept risk of scar, infection, minor bleeding, permanent or prolonged hyperpigmentation and hypopigmentation.
研究组 & 干预措施
Pulsed dye laser
Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
干预措施: Pulsed dye laser (Device)
Curettage
Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
干预措施: Curettage (Procedure)
Electrodesiccation
Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
干预措施: Electrodesiccation (Procedure)
No treatment
Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
干预措施: No treatment (Other)
结局指标
主要结局
Percent Clearance of All Lesions
时间窗: 6 to 12 weeks
The physician assessed percent clearance of all treated lesions and the control lesion.
次要结局
未报告次要终点