NCT00204542已完成4 期
Comparison of the Efficacy and Tolerability of Solaraze for 3 vs. 6 Months in Patients With Mild to Moderate Actinic Keratosis Located at the Face and Head
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
- 418
- 试验地点
- 4
- 主要终点
- Histologically controlled complete clearance of the actinic keratosis
研究概览
简要总结
Topical treatment of mild to moderate actinic keratosis located on the face and head with Solaraze® is known to be a safe and efficient treatment option. However, it is unclear if an expansion of the treatment period to 6 months will increase the rate of complete responses.
Therefore the investigators will evaluate the efficacy and safety of the treatment of actinic keratosis with Solaraze® applied twice daily to the face and head over 3 or 6 months of 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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visible and histologically proven actinic keratosis
- •Prepared and able to give written informed consent
- •≥ 18 -80 years of age
- •Prepared and comply with all study requirements, including the following: application of gel on the treatment area twice a day, 5 / 7 clinic visits during the prestudy, treatment, posttreatment, and follow-up period
- •Pre- and posttreatment biopsy for histological confirmation (of clearance) of actinic keratosis diagnosis
排除标准
- •Data of clinically significant, unstable, cardiovascular or haematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or diseases
- •Known allergies to any excipient in the study drug
- •Any dermatological disease and/or condition in the treatment or surrounding area (3 cm distances from treatment area) that may be exacerbated by treatment with diclofenac or cause difficulty with examination
- •Active chemical dependency or alcoholism, as assessed by the investigator
- •Currently participating in another clinical study or have completed another clinical study with an investigational drug within the past 30 days
- •Received topical treatment at the treatment area with imiquimod or 5-FU within a time period of 1 month
- •Invasive tumours within the treatment area, e.g. merkel cell carcinoma, squamous cell carcinoma, basal cell carcinoma, the latter is accepted if completely surgically removed
研究组 & 干预措施
A
Active Comparator
Solaraze(R) 2x/day for 3 months
干预措施: Diclofenac (Drug)
B
Active Comparator
Solaraze(R) 2x/day for 6 months
干预措施: Diclofenac (Drug)
结局指标
主要结局
Histologically controlled complete clearance of the actinic keratosis
时间窗: 6 weeks after end of treatment
次要结局
未报告次要终点
研究者
研究点 (4)
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