A Phase II Randomized, Open-label Study Investigating the Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Healthpoint
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH).
研究概览
简要总结
This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs surgery.
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
- 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
- •Provide informed consent.
- •Age ≥ 18 years and of either sex.
- •Type I, II, or III skin as assessed by the Fitzpatrick Scale.
- •Willing to comply with protocol instructions, including allowing all study assessments.
- •Scheduled to have head or neck non-melanoma skin cancers removed by Mohs micrographic surgery with final wound size of 8 mm to 20 mm in diameter or with 8 mm to 20 mm long axis if not circular.
- •Acceptable state of health and nutrition, in the opinion of the Investigator.
排除标准
- •History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, or amphotericin B.
- •Therapy with blood-thinning agents including aspirin within 14 days of the Baseline Visit (these may be resumed post-surgery).
- •Subjects with platelet or coagulation disorders.
- •Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
- •Current systemic therapy with cytotoxic drugs.
- •Current therapy with chronic (> 10 days) oral corticosteroids.
- •In the opinion of the Investigator the subject has a current life expectancy of less than 1 year.
结局指标
主要结局
The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH).
时间窗: 13 weeks- The IGAH was measured at study Weeks 4 and 13
The IGAH is a four-point scale based on the following assessment scores: 0 = not effective, 1 = slightly effective, 2 = moderately effective, 3 = very effective. The descriptive statistics for both a continuous variable and a categorical variable were summarized for IGAH by treatment week and treatment endpoint. The Wilcoxon rank-sum test was used to test the difference in IGAH score between HP802-247 and bacitracin ointment for each treatment week and treatment endpoint. Since this was a small and exploratory study, the P-value of a 1-sided test was reported.
次要结局
- Investigator Reported Signs and Symptoms(At each evaluation visit: Weeks 3 and 12 post-surgery.)
- Subject Reported Signs and Symptoms(At each evaluation visit: Weeks 3, and 12 post-surgery.)
- Time in Days to Wound Closure(Over the 12 week treatment period)
- The Number of Subjects With Complete Wound Closure at Each Evaluation Visit.(Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks)