NCT01806961终止不适用
Observational (Non-interventional), Follow-up Trial Assessing Long-term Local Tolerability and Efficacy (Recurrence Rate) of Resiquimod Gel in Patients Treated for Actinic Keratosis.
Spirig Pharma Ltd.9 个研究点 分布在 2 个国家目标入组 16 人开始时间: 2013年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 9
- 主要终点
- Determine the Recurrence Rate of AK-lesions
研究概览
简要总结
Determine the recurrence rate of actinic keratosis (AK) lesions in patients with complete clinical clearance at the end of the previous trial SP848-AK-1101 at 6 and 12 months of follow-up.
详细描述
Efficacy Evaluation:
• Primarily based on clinical inspection of the former 25 cm2 treatment area and count of the AK-lesions.
Safety Evaluation:
- Evaluation of adverse events (AEs) and serious adverse events (SAEs)
- Evaluation of newly occurred dermal adverse events (AEs) and serious adverse events (SAEs) in the previous treatment area at 6 months and 12 months of follow-up (local tolerability).
- Follow-up of unresolved adverse and serious adverse events that occurred in the previous trial SP848-AK-1101.
- Follow-up of unresolved abnormal laboratory values that occurred in the previous trial SP848-AK-1101.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Signed informed consent.
- •Participation in the previous clinical trial SP848-AK-
- •Patient with complete clinical clearance (i.e. no previously existing AK-lesion present) at the end of the trial SP848-AK-1101 or Non-Responder who withdrew from the trial prematurely.
排除标准
- •Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., cardiovascular, immunological, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, infectious, gastrointestinal abnormalities or diseases).
- •Evidence of systemic cancer.
- •Dermatological disease or condition in the former treatment or surrounding area that might impair trial assessments (e.g., rosacea, atopic dermatitis, eczema) as assessed by the investigator.
结局指标
主要结局
Determine the Recurrence Rate of AK-lesions
时间窗: at 6 and 12 months
Number of patients with persistent complete clearance at 6 and 12 months follow-up. Recurrence rate is to be determined at the same treatment area where the investigational medicinal products were administered in the previous trial.
次要结局
- Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area(at 6 and 12 months)
- Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes)(at 6 and 12 months)
研究者
研究点 (9)
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