NCT00849992已完成4 期
Randomized Prospective Study Comparing 5% Imiquimod and Photodynamic Therapy for Actinic Cheilitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- clinical and pathological complete cure rates.
研究概览
简要总结
Actinic cheilitis is a common precancerous lesion of the lip. The purpose of this study is to compare imiquimod 5% therapy and photodynamic therapy. The data will include effect data, histology (skin analysis), epidemiological data and follow-up data.
详细描述
Randomized study comparing imiquimod 5% with photodynamic therapy for actinic cheilitis. Histological, efficacy, epidemiological and clinical data will be collected.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical findings of actinic cheilitis.
- •Histological findings demonstrating epithelial changes equal to or greater than mild epithelial dysplasia in severity (mild - moderate - severe).
- •Age above
- •Willingness to take post-treatment biopsy.
排除标准
- •Disorders predisposing to photosensitivity (porphyria, SLE).
- •Pregnancy or nursing.
- •Known allergy to any excipients in the study creams.
- •prescribed topical retinoids, 5-fluorouracil, cryodestruction, surgical excision and curettage.
研究组 & 干预措施
Imiquimod 5%
Other
Patients randomized to this arm will receive treatment with imiquimod 5%
干预措施: Imiquimod 5% (Drug)
Photodynamic therapy
Other
Patients will be randomized to receive photodynamic therapy twice at a 2 week interval to the affected area.
干预措施: Photodynamic therapy (Procedure)
结局指标
主要结局
clinical and pathological complete cure rates.
时间窗: 3 and 12 months after therapy
次要结局
- clinical, safety, epidemiological and histopathological data(post-treatment)
研究者
研究点 (1)
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