OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Acceptability of the treatment
研究概览
简要总结
OneDoc Picopulse™ is a radiopulse technology beauty grade device invented for treating melasma.
详细描述
This is a new attempt to evaluate the effectiveness of OneDoc PicopulseTM in treating melasma among women of childbearing age in Klang Valley, Malaysia. This pilot feasibility study protocol is to access feasibility of the OneDoc Picopulse™ in the future definitive trial. The findings of this study would justify OneDoc Picopulse™ as one of the promising alternative treatment for melasma.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women presenting dermal melasma with Fritzpatrick skin type III to V
- •Malaysian citizen
- •Agreed to participate
- •Provide informed consent
排除标准
- •Patients who had a laser procedure, phototherapy therapy, peel, oral therapy, topical treatment or used lightening creams in the treatment area within the past 6 months.
- •Patients with pregnancy, lactating, active dermatitis, had a history of immunosuppression/immune deficiency disorders
- •Patients who photosensitivity or taking drugs known to induce photosensitivity,
- •Patients that have been exposed to severe sun exposure, having severe epidermal injury, allergy and sensitivity
- •Patients who could not attend follow-up treatments
结局指标
主要结局
Acceptability of the treatment
时间窗: One month
Short Assessment of Patient Satisfaction (SAPS) questionnaire with additional Qualitative data collection; The score range for SAPS is from 0 (extremely dissatisfied) to 28 (extremely satisfied)
次要结局
- Melasma(Through study completion, an average of 24 weeks)
- Feasibility of the recruitment and measurement tools(Pre-treatment, two weeks and one month)
- Treatment adherence(five months)
- Safety evaluation(immediately after and before each subsequent treatment)
- Quality of life of patients(Pre-treatment, two weeks and one month post-treatment)
研究者
Yang Mooi Lim
Deputy Director (Institute of Postgraduate Studies and Research), Professor
Universiti Tunku Abdul Rahman