EUCTR2008-002632-15-DE进行中（未招募）不适用
Randomized, multicenter, double blind study to compare the efficacy and tolerability of Oleogel-S-10 for 3 months versus placebo only in patients with mild to moderate ac-tinic keratoses located at the face and head - BETA-Trial
Birken GmbH0 个研究点目标入组 162 人开始时间: 2008年7月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 162
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •At least two mild to moderate actinic keratoses located at the facial skin or the head (except lips)
- •histologically proven AK within three months before study entry.
- •prepared and able to give written informed consent
- •= 18 years of age
- •prepared and comply with all study requirements, including the following:
- •application of Oleogel-S10 on the treatment area once or twice a day
- •4 clinic visits during the pre-study, treatment, post-treatment, and follow-up
- •pre- and post-treatment biopsy for histological confirmation (of clearance) of
- •AK-diagnosis
- •Representative histologic slide and tissue block were shipped
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Active immunosuppressive therapy
- •data of clinically significant, unstable, cardiovascular or haematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or diseases
- •Note: Patients with clinically stable medical conditions including, but not limited to, controlled hypertension, diabetes mellitus type II, hypercholesterolemia, or os-teoarthritis will be allowed to enter the study
- •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 Oleogel-S-10 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 diclofenac gel, imiquimod or 5-FU within a time period of 1 month
- •Invasive tumors within the treatment area, e.g.: merkel cell carcinoma, squamous cell carcinoma, basal cell carcinoma, the latter is accepted if completely surgically removed
- •Note: A biopsy of any lesion within the treatment or surrounding area suggestive of malignancy should be performed at the pre-study screening visit. If invasive SCC or other malignant conditions are confirmed within the treatment area, the pa-tient will not be included in the study
研究者
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