Evaluation of the Efficacy and Safety of the Imiquimod 5% Topical Cream in Plaque Morphea: A Prospective, Multiple Baseline, Open Label Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percent improvement in the thickness of the skin
研究概览
简要总结
Morphea is very hard to treat. In a small number of adult patients, Imiquimod has proven to be beneficial in decreasing the thickness of the morphea plaques , while improving their appearance. There are no studies to date proving its safety and efficacy in children with this disease. We propose to conduct a pilot study to assess to potential efficacy and relative safety of Imiquimod in children with plaque morphea.
详细描述
Design: Prospective, open label, pilot study
Settings: The Hospital for Sick Children, Specialized Morphea Clinic
Study population:
- Children 6-18 years of age
- Plaque morphea measuring less than 10 cm2 in diameter ( for children with multiple lesions, only one will be treated)
Intervention: Topical imiquimod applied 3-5 times a week for 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at diagnosis 6 to 18 years of age
- •Morphea plaques
- •Female subjects of childbearing potential must have a negative urine pregnancy test
- •Signed consent/assent form
- •Exclusion criteria:
- •Children who received topical corticosteroids, tacrolimus, vitamin D derivatives (calcipotriol, calcipotriol-betamethasone dipropionate) to the affected area in the previous four weeks
- •Children who were previously treated with Imiquimod on the affected areas
- •Children with no demonstrable ultrasonographic changes at the baseline evaluation
- •Children with evidence of skin breakdown on the proposed area to be treated at the time of enrollment due to potential increased absorption of the medication through impaired skin barrier
- •Female subjects of childbearing potential who do not agree to practice effective birth control methods for the duration of the study
- •Children who are/were (in the past 6 months) treated with systemic medications such as methotrexate and/or systemic corticosteroids
- •Co-morbidities: systemic sclerosis, juvenile rheumatoid arthritis, other systemic diseases
排除标准
- 未提供
研究组 & 干预措施
1
干预措施: Imiquimod 5% cream (Drug)
结局指标
主要结局
Percent improvement in the thickness of the skin
时间窗: 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks
次要结局
- Frequency of side-effects(48 weeks)
研究者
Elena Pope
Head, Section of Dermatology
The Hospital for Sick Children