A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy and Safety Study of KX2-391 Ointment 1% in Adult Subjects With Actinic Keratosis on the Face or Scalp
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 29
- 主要终点
- Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions
研究概览
简要总结
This Phase III study was designed to evaluate the efficacy and safety of KX2-391 Ointment 1% in adult participants when applied to an area of skin containing 4-8 stable, clinically typical actinic keratosis (AK) lesions on the face or scalp.
详细描述
This study was a double-blinded, multicenter, efficacy, and safety study of KX2-391 ointment administered topically to the face or scalp of participants with AK.
The study consisted of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible participants received up to 5 consecutive days of topical treatment. Efficacy (lesion counts) and safety evaluations were performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All Central Vendors and the sponsor were masked. The sponsor was unblind at the end of Day 57.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
KX2-391 Ointment 1%
KX2-391 Ointment was applied once daily for 5 consecutive days on the face or scalp.
干预措施: KX2-391 Ointment 1% (Drug)
Placebo
The Vehicle Ointment was applied once daily for 5 consecutive days on the face or scalp.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions
时间窗: Day 57
Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.
次要结局
- Number of Participants With Pigmentation and Scarring in the Treatment Area(Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57)
- Number of Participants With Clinically Significant Safety Observations- Vital Signs(From Baseline (Day 1 predose) up to Day 57)
- Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57(Day 57)
- Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57(Days 8, 15, 29 and 57)
- Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)(Day 57)
- Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis(From Baseline (Day 1 predose) up to Day 57)
- Number of Participants With Clinically Significant Safety Observations- Electrocardiograms (ECGs)(From Baseline (Day 1 predose) up to Day 57)
- Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57(3, 6, 9 and 12 months post-Day 57)
- Number of Participants With Clinically Significant Safety Observations- Physical Examination(From Baseline (Day 1 predose) up to Day 57)
- Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests(Baseline (Day 1 predose) up to Day 57)
- Number of Participants With Adverse Events, Serious Adverse Events, Events of Special Interests Within the Treatment Area After Day 57 and up to 12 Months Post-Day 57(From Day 57 up to 12-months post-Day 57)