Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year After Completion of Studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 主要终点
- Number of Participants With Recurrence of AK Lesions
研究概览
简要总结
The objective of this study was to obtain long-term sustained clearance rates for subjects previously treated with imiquimod creams in studies GW01-0702, GW01-0703, GW01-0704 and GW01-0705.
详细描述
This is a Phase 3 longitudinal and observational study. Subjects who previously enrolled in studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705 and were completely cleared of their AK lesions in the selected treatment area at the end-of-study visit will return for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
The NCT numbers for the above mentioned studies are:
NCT00603798 - for Studies GW01-0703 and GW01-0705
NCT00605176 for Studies GW01-0702 and GW01-0704
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
- •Are willing and able to give informed consent;
- •Have successfully completed one of the following studies: GW01-0702, GW01- 0703, GW01-0704, or GW01-0705 and have been determined to be completely clear of AK lesions at the EOS visit in the designated treatment area from the previous study
- •Are willing to participate in the study as an outpatient, make visits to the study center for follow-up evaluation, and agree to comply with all study requirements.
排除标准
- •None. All subjects who meet the inclusion criteria above may participate.
结局指标
主要结局
Number of Participants With Recurrence of AK Lesions
时间窗: Up to one year
The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.
次要结局
未报告次要终点