Evaluation of the Efficacy and Safety of Imiquimod 5% Cream in Plaque-type Morphea: A Pilot, Prospective Open-label Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- The main outcome of this study is to evaluate the efficacy of imiquimod cream in improving morphea plaques. Improvement of skin induration will be measured by percent improvement in the skin induration as assessed radiologically by ultrasonography score.
研究概览
简要总结
Localized scleroderma or morphea is a fibrotic disease, imiquimod induces cytokines which inhibit fibrotic activity . We propose that topical imiquimod 5% cream is efficacious and safe in treating plaque-type morphea. Twenty adults will be enrolled for a pilot study. A screening and baseline clinic visit will be required for each patient enrolled in the study. Each visit will involve completing a medical history, skin examination, digital pictures, histologic examination if the patient consents and an ultrasonographic score. One morphea plaque will be treated with topical imiquimod 5% cream, and another morphea lesion with vehicle cream. Patients will be asked about side effects (local and systemic). Patients will be followed up in the clinic at 3, 6 and 9 months of therapy, and 3 months following end of treatment period (month 12).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults and children > 6 years with plaque-type morphea
- •Subject has not participated in previous study involving imiquimod for three months
- •In the investigator's judgement, imiquimod treatment may benefit the patient over conventional treatment
- •Subject has provided informed written consent
- •Female subjects of childbearing potential have a pregnancy urine test that is negative prior to treatment
- •Sexually active subjects agree to practice effective birth control throughout the duration of the study
排除标准
- •Patients with a non-morphea skin disorder in the region of interest
- •Subjects previously undergoing morphea therapy within four weeks of the study
- •Subjects have a known hypersensitivity to imiquimod or component of the cream preparation
- •Subjects who are pregnant or nursing
结局指标
主要结局
The main outcome of this study is to evaluate the efficacy of imiquimod cream in improving morphea plaques. Improvement of skin induration will be measured by percent improvement in the skin induration as assessed radiologically by ultrasonography score.
次要结局
- Any adverse outcome is recorded.