A Single Centre Retrospective Chart Review Study to Assess the Efficacy of the GenesisPlus 1064 nm Nd:YAG Laser in the Treatment of Onychomycosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- change in % of infected toenail involvement
研究概览
简要总结
The purpose of this study is to determine if toenail onychomycosis can be reduced by means of exposure to laser energy from the Cutera® GenesisPlus 1064 Nd:YAG laser system.
详细描述
This is a retrospective, open-label, single-centre study for the collection of clinical data on the efficacy and safety of the Cutera® GenesisPlus 1064 nm Nd:YAG laser for the treatment of nail fungus (onychomycosis). Safety and efficacy of treatment with the GenesisPlus laser will be evaluated by (1) assessment of subject's great toenail photographs at baseline and after two treatments with GenesisPlus Laser utilizing planimetry measurement of infected vs. clear nail area in target toenail photographs, (2) by clinical and subjective review of acute and follow up adverse events that may have resulted from laser treatment of the target toenails.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female subjects, age 18 to 80 years (inclusive).
- •Subject with a clinical diagnosis of onychomycosis of one or both great toenails at baseline.
- •Subject with a positive potassium hydroxide (KOH) stain and/or fungal culture.
- •Subject has baseline and post treatment digital photographs of target great toenails.
- •Subjects provided informed consent for treatment of nails with the Cutera GenesisPlus laser system.
排除标准
- •Subjects have received laser treatment of the infected great toenail(s) with a non-Cutera® laser system within twelve (12) months prior to Cutera® GenesisPlus laser treatment.
- •Subjects have had a history or clinical diagnosis of moccasin type tinea pedis, lichen planus, psoriasis or bacterial nail infection.
- •Subjects had a history or clinical diagnosis of coexisting disorders that may potentially demonstrate nail manifestations.
- •Systemic antifungal medication within six (6) months prior to or following Cutera® GenesisPlus laser treatment.
- •Subjects who have had a history or clinical diagnosis of repetitive nail trauma prior to treatment.
- •Subjects who have participated in any clinical research study within thirty (30) days prior to or within 210 days following final Cutera® GenesisPlus laser treatment.
- •Subjects who were pregnant or breastfeeding.
结局指标
主要结局
change in % of infected toenail involvement
时间窗: change from baseline up to 6 months
onychomycosis involvement
次要结局
未报告次要终点
研究者
Jason K Rivers, MD, FRCPC, FAAD
Principal Investigator
Pacific Dermaesthetics