A Randomized Controlled Trial on the Effectiveness of Epidermal Growth Factor-containing Ointment on the Treatment of Solar Lentigines as Adjuvant Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of pigmentation by physician's assessment
研究概览
简要总结
Subjects were randomly assigned to groups for treatment with either an EGF-containing ointment (the study group) or the vehicle alone (petrolatum; the control group). The EGF ointment included recombinant human EGF (1 μg/g). Random numbers used for assignment to groups were provided by the randomization function of SAS.
The subjects received one session of laser treatment with a Q-switched (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser of their solar lentigines after enrollment. . The end point of laser treatment for lentigines was immediate whitening. The subjects then applied the EGF ointment or vehicle twice daily (morning and evening) to the lesion for 4 weeks after laser treatment.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of solar lentigines that occurred after adulthood
- •age of 20 years or older.
排除标准
- •uncontrolled systemic or chronic disease
- •hypersensitivity to the ingredients of the ointment
- •current use of skin whitening agents
- •a history of other laser treatments within the past 6 months
- •pregnancy
- •lactation.
研究组 & 干预措施
epidermal growth factor (EGF) containing ointment group
The subjects received one session of laser treatment with a Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser after enrollment.
The procedure parameters were as follows: 5-10-ns pulse duration, 3.5-mm spot size, 0.9-1.1-J/cm2 fluence, and 2-Hz frequency.
The end point of laser treatment for lentigines was immediate whitening. The subjects then applied the epidermal growth factor (EGF) ointment twice daily (morning and evening) to the lesion for 4 weeks after laser treatment.
干预措施: epidermal growth factor (EGF)-containing ointment (Drug)
Vehicle ointment group
The subjects received one session of laser treatment with a Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser of their solar lentigines after enrollment.
The procedure parameters were as follows: 5-10-ns pulse duration, 3.5-mm spot size, 0.9-1.1-J/cm2 fluence, and 2-Hz frequency.
The end point of laser treatment for lentigines was immediate whitening. The subjects then applied the vehicle ointment twice daily (morning and evening) to the lesion for 4 weeks after laser treatment.
干预措施: Vehicle ointment (Drug)
结局指标
主要结局
Change of pigmentation by physician's assessment
时间窗: Change from baseline pigmentation at 8 weeks
The pigment clearance was assessed using a 5-grade percentage improvement scale grade 1, \<0% \[worse\]; grade 2, 0%-25% improvement; grade 3, 26%-50% improvement; grade 4, 51%-75% improvement; grade 5, 76%-100% improvement -\> higher score means better outcomes
次要结局
- Erythema index(8 weeks)
- Transepidermal water loss(8 weeks)
- Patient's subjective satisfaction(8 weeks)
- Melanin index(8 weeks)
研究者
Bo Young Chung
Principal Investigator, Clinical Professor
Hallym University Kangnam Sacred Heart Hospital