Phase 2B Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Complete Clearance Rate
研究概览
简要总结
This is a Phase 2 clinical study in patients with actinic keratosis involving daily application of 1 of 2 strengths of VDA-1102 topical ointment for approximately 12 weeks (84 days). This study has no placebo and the subjects enrolled in the study will know exactly what they are receiving. The objectives of the study are to evaluate the safety and benefit of these two strengths.
详细描述
This Phase 2 clinical trial is a 3-part, open-label, multi-center study involving a non-occluded, daily topical dermal application of 1 of 2 strengths of VDA-1102 ointment for approximately 12 weeks (84 days) to an initial 2 cohorts of subjects. The first 40 eligible subjects will be enrolled into Cohort 1 (Part A). Cohort 1 subjects will be assigned to receive approximately 200 mg of 10% VDA-1102 twice-daily (BID). Once approximately 40 subjects have been enrolled in Cohort 1, Cohort 1 will be closed to enrollment and Cohort 2 (Part B) will be opened for enrollment. Cohort 2 subjects will be assigned to receive approximately 200 mg of 20% VDA-1102 once-daily (QD). Once approximately 40 subjects have been enrolled in Cohort 2, an additional 70 subjects will be randomly assigned to Cohort 1 or Cohort 2 (Part C) in a 1:1 ratio.
To qualify for the study, subjects aged 18 (inclusive) or older must have signed informed consent and met the study enrollment criteria that include having 4-8 actinic keratosis (AK) lesions within an approximate 25 cm2 area on the cheek, forehead, or hairless scalp (the "Treatment Field").
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •4-8 grade 1 or grade 2 AK lesions in Treatment Field on face or scalp
排除标准
- •Subject has no clinically significant findings at Baseline
- •Subject is unable to demonstrate adequate precision applying the study drug to the Treatment Field at Baseline
- •Subject has in the opinion of the Investigator (a) an unstable medical, psychiatric, social problem
- •Subject has at any time been given a diagnosis or treatment associated with immunosuppression
- •Subject has received VDA-1102 in the past
研究组 & 干预措施
Cohort 1
10% VDA-1102
干预措施: 10% VDA-1102 (Drug)
Cohort 2
20% VDA-1102
干预措施: 20% VDA-1102 (Drug)
结局指标
主要结局
Complete Clearance Rate
时间窗: Week 16
Efficacy will be evaluated by the proportion of subjects achieving complete clearance of AK lesions in the treatment field of subjects in each treatment arm
Complete Facial Clearance Rate
时间窗: Week 16
Efficacy will be evaluated by the proportion of subjects achieving complete clearance of facial AK lesions in the treatment field of subjects in each treatment arm
次要结局
- Partial Clearance(16 weeks)
- Lesion Number Reduction on Face(16 weeks)
- Partial Facial Clearance(16 weeks)
- Lesion Number Reduction(16 weeks)