The Effects of Aldara as an Adjunct to Laser Treatment of Port Wine Stains
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation)
研究概览
简要总结
The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations.
详细描述
This is a randomized, controlled, double-blinded study. Volunteers who are scheduled for laser treatment of Port Wine Stains will be screened and eligible subjects will be asked to participate. The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient between the ages of 2 and 60 years with a vascular malformation that is seeking cosmetic treatment.
- •All races will be included as well as male and female.
- •Clinical data on the usage of Aldara below the age of 2 years is limited and therefore all patients in the study will have to be at least 2 years of age.
- •The majority of port wine stains are initially treated during childhood
- •In order to determine the effectiveness of Aldara as an adjunct to laser therapy of Port Wine Stains, some of the patients in the study need to have lesions that have not undergone previous treatment.
排除标准
- •Patients under the age of 2 or over the age of
- •Patients that have serious medical problems that would put them at risk of the anesthesia.
- •Patients that have sensitivity reactions to the ingredients in the product including imiquimod, isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben.
- •Patients who are pregnant or have significant immunodeficiency or autoimmune diseases.
研究组 & 干预措施
Aldara cream
Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
干预措施: Imiquimod (Drug)
non-medicated petroleum cream
Non-medicated petroleum cream will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
干预措施: non-medicated petroleum cream (Drug)
结局指标
主要结局
Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation)
时间窗: 3 months
Lesions will be digitally photographed and its surface area measured by blinded observers using image analysis software
次要结局
未报告次要终点
研究者
Henry Vasconez
principal Investigator
University of Kentucky