Comparing the Efficacy and Risk of Adverse Events of Electrocautery Versus 532 nm Qswitched Neodymium-doped Yttrium Aluminium Garnet Laser for the Treatment of Flat Seborrheic Keratoses: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in lesion texture from baseline to week 18
研究概览
简要总结
The primary objective of this study is to compare the efficacy and risk of adverse events of electrocautery versus 532 nm Q-switched neodymium-doped yttrium aluminium garnet (Nd:YAG) laser for the treatment of flat seborrheic keratoses.
This study is a pilot study designed to determine feasibility of these procedures.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are Caucasian or Asian.
- •Subjects who are between 18-65 year olds.
- •Subjects have flat or macular seborrheic keratosis on dorsum of the hands and wrists, extensor surfaces of the forearms. The diagnosis of flat seborrheic keratosis is confirmed by two clinical dermatologists using routine clinical examination and dermoscopy.
- •Subjects have Fitzpatrick skin type I-III.
- •Subjects are in good health.
- •Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.
排除标准
- •History of keloids or hypertrophic scars.
- •Pregnant or lactating or intends to become pregnant in the next 3 months.
- •Active skin disease or skin infection in the treatment area.
- •Previous history of lidocaine allergy.
- •History of methemoglobinemia
- •Unable to understand the protocol or to give informed consent.
- •Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study or would pose as an unacceptable risk to subject.
结局指标
主要结局
Change in lesion texture from baseline to week 18
时间窗: Baseline and 18 weeks
Blinded photo raters will the lesion texture on a scale of -50 (most worsening relative to baseline) to +50 (most improvement relative to baseline) for both treatments.
Change in Pigmentation from baseline to week 18
时间窗: Baseline and 18 weeks
Blinded photo raters will the lesion pigmentation on a scale of -50 (most hypopigmented relative to baseline) to +50 (most hyperpigmented relative to baseline) for both treatments.
次要结局
未报告次要终点
研究者
Murad Alam
Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery
Northwestern University