Comparative Study Investigating the Therapy of of Solar Lentigines With the Q-switched SINON Rubin 694nm Laser Versus Pigmanorm® Cream
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Evaluation of clearing of pigmentation
研究概览
简要总结
Benign pigmented lesions as solar lentigines are a common finding in Caucasian individuals. Their removal may be requested for aesthetic reasons.
The goal of the study is comparing the efficacy and tolerance of two different therapy modalities established for treating solar lentigines.
The right back of the hand side will be treated with the Q-switched SINON Rubin 694nm Laser, the left back of the hand side with a hydrochinon containing bleaching cream (Pigmanorm® cream).
The investigators estimate that a physical therapy with a Q-switched Rubin laser system is more effective in the removal of solar lentigines than a topical chemical therapy with a hydrochinon containing bleaching cream.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •female patient must be in post-menopause (> 2 years)
- •Clinically and dermoscopic confirmed solar lentigines on both sides back of the hands
排除标准
- •non melanocytic pigmentation, vitiligo, melanoma and suspicion of melanoma
- •intolerance against an ingredience of pigmanorm® cream
- •acute inflammation or eczema on back of the hands
- •patients with renal disease
- •intake of photosensibilisating medication in the past 3 months
- •treatment of solar lentigines on back of the hands in the past 6 months
- •solarium or sun exposure about 6 weeks before and after treatment
- •immunsuppressed patients
研究组 & 干预措施
Pigmanorm Cream, Q-switched Ruby laser,solar lentigines
Solar lentigines on the left back of the hand side are treated with Pigmanorm Cream once a day for 7 weeks. Solar lentigines on the right back of the hand side are treated with a Q-switched Ruby laser at Baseline and if required at day 28.
干预措施: Q-switched SINON Ruby Laser (Device)
Pigmanorm Cream, Q-switched Ruby laser,solar lentigines
Solar lentigines on the left back of the hand side are treated with Pigmanorm Cream once a day for 7 weeks. Solar lentigines on the right back of the hand side are treated with a Q-switched Ruby laser at Baseline and if required at day 28.
干预措施: Pigmanorm Cream (Drug)
结局指标
主要结局
Evaluation of clearing of pigmentation
时间窗: 140 days (Baseline, Day 28, Day 56, Day 140)
The primary efficacy objective is to evaluate the clearing of pigmentation(percentage of clearing) following a quartile scale of poor (25% clearance), fair (26-50% clearance), good (51-75% clearance), and excellent (76-100% clearance).
次要结局
- Evaluation of safety profile(140 days (Baseline, Day 28, Day 56, Day 140))
- Change from Baseline in Pigmentation at day 140(Long term outcome is assessed 3 months after finishing treatment.)