NCT00725439已完成2 期
An Open Label Pilot Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment of Moderate to Severe Facial Acne
Stiefel, a GSK Company3 个研究点 分布在 2 个国家目标入组 16 人开始时间: 2004年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Facial Lesion Count
研究概览
简要总结
This study is looking at a new oral drug to treat acne. All patients in the study will get active drug, there is no placebo arm.
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
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subject
- •Presence of moderate to severe facial acne vulgaris: having a minimum of 15 papules and/or pustules and at least 2 nodulocystic lesions
- •In good general health and free of any disease state or physical condition which, in the investigator's opinion, might have impaired evaluation of acne or exposed the subject to an unacceptable risk by trial participation
排除标准
- •Subjects with types of acne other than acne vulgaris
- •Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, or a history indicating adrenal cortex dysfunction or any other serious disease (including cancer and subjects known to be HIV positive)
- •History of any malignancy in the past 5 years, except for adequately treated basal cell carcinoma of the skin
- •History of heart failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders
- •Clinically significant abnormal ECG-intervals or morphology of the ECG; QT or QTc >470 ms in females or >450 ms in males
- •Use of vitamin A (>1000 microgram/day), phenytoin, carbamazepine, warfarin, rifampicin, tetracyclines, ketoconazole, itraconazole, astemizole, terfenadine, cisapride, anti-psychotics, anti-depressants, lithium, antimalarials, alpha-blocking drugs, angiotensin-converting enzyme inhibitors, cyclosporin A, glucocorticosteroids and non-steroid anti-inflammatory drugs, non-potassium-sparing diuretics
- •Use of oral retinoids 6 months prior to Visit 1
- •Use of other oral/topical therapy for acne unless stopped at Visit 1
- •Use of ultraviolet light (including artificial UVA and UVB as well as excessive natural sun exposure) unless stopped at Visit 1
研究组 & 干预措施
A
Experimental
Talarozole
干预措施: Talarozole (Drug)
结局指标
主要结局
Facial Lesion Count
时间窗: Post 12 weeks treatment
次要结局
未报告次要终点
研究者
研究点 (3)
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