Treatment With Topical Eflornithin After Laser Treatment in Women With Facial Hirsutism
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- blinded photo-evaluation of change in facial hirsutism by hair count in a standardized square field
研究概览
简要总结
Split-face investigation of the efficacy of applying Eflornithin cream twice daily for six months after a period with six laser treatments for hair removal.
详细描述
Background: Unwanted facial hair growth is a serious problem for 5-15% of all women winch affects their quality of life. In Denmark patients are offered six laser treatments covered by the public health insurance. There is a lack of good follow-up treatments to this regime that can extent the efficacy of the laser treatment. Eflornithin cream is an approved treatment for reduction of facial hair growth which has proved to give an additional efficiency when used in combination with laser treatments.The efficacy when used after laser hair removal is not known.
Aim: To investigate whether an extended efficacy of laser hair removal can be achieved with application of Eflornithin cream twice daily for six months after completion of laser treatments.
Method: in a split-face trial to apply Eflornithin cream twice daily for six months. Outcome measures are investigator evaluation, blinded on-site evaluation, patient's assessment score and clinical photos.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •habile, understands Danish
- •moderate to severe hirsutism prior to laser treatments
- •succeeded minimum five laser treatments
- •intact skin with no severe adverse events to laser treatments
- •record of current medication and androgen hormone blood profile available
- •Use of safe anti-conception (fertile women)
排除标准
- •Pregnant or lactating
- •allergy toward the content of Eflornithin cream
- •Concomitant use of immunosuppressive therapy
- •Dementia, psychiatric disease, alcoholic
研究组 & 干预措施
split-face eflornithin vs. no treatment
Eflornithine cream 11.5 W/W% applied twice daily to one side of the face for six months
干预措施: Eflornithine cream 11.5 w/w % (Drug)
结局指标
主要结局
blinded photo-evaluation of change in facial hirsutism by hair count in a standardized square field
时间窗: baseline, 1, 3 and 6 months
次要结局
- Doctors blinded on-site evaluation of efficacy(Baseline, 1, 3 and 6 months)
- Patient's overall satisfaction(Baseline, 1, 3 and 6 months)
- Patient's assessment of efficacy(Baseline, 1, 3 and 6 months)
- Patient's assessment of adverse events(Baseline, 1, 3 and 6 months)
- Doctor's on-site blinded assessment of adverse events(Baseline, 1,3 and 6 months)
- Patient's overall impression of efficacy(Baseline, 1,3 and 6 months)
研究者
Elisabeth Taudorf
MD PhD student
Bispebjerg Hospital