A Phase 2, Prospective, Randomized, Double-Blind, Parallel-Group, Within-Subject Vehicle Controlled Multicenter Study of the Efficacy and Safety of Granexin® Gel to Improve Burn Wound Healing
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Time to re-epithelization
研究概览
简要总结
To evaluate the efficacy of Granexin® gel to promote accelerated healing of second-degree (deep partial thickness) thermal burns.
详细描述
Multi-center, prospective, randomized, double-blind, parallel-group, within-subject Vehicle controlled, safety and efficacy trial involving subjects with two comparable (similar body location, similar burn area and burn severity), noncontiguous deep second-degree thermal burns of less than 20% TBSA. A total of 30 subjects will have two target burns randomly assigned in a ratio of 1:1 to two treatment groups.
- Granexin® gel (200 μM) plus ACTICOAT Flex 3TM
- Vehicle gel plus ACTICOAT Flex 3TM
The study procedures are divided into the following three periods:
- Screening (within 36 hours of the time of injury)
- Treatment (daily for 10 days)
- Follow-up (Day 10 through Month 12)
The anticipated total duration of a given subject's participation in this study is 12 months. Screening can occur up to 36 hours prior to Day 0; Screening and Day 0 may occur on the same day. Treatment period visits occur daily from Day 0 through Day 9, on-site and remotely. During the treatment period, each subject will be treated with Granexin® gel (200 μM) plus ACTICOAT Flex 3TM on one target burn and Vehicle gel plus ACTICOAT Flex 3TM on the second target burn. After Day 9, the subject will return to clinic on Day 10 and be followed-up (on-site or remotely) every other day thereafter until Day 28, with on-site visits on Days 14, 20, and 28. The subject will then return to the clinic for follow-up visits at Months 6, 9, and 12.
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)
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
Granexin gel
Within-subject comparison of Granexin® Gel versus vehicle gel (placebo).
Granexin® gel 200 μM will be applied daily over ten days. Granexin® will be applied to one of two selected target burns.
干预措施: Granexin® gel (200 μM) (Drug)
Vehicle Gel
Within-subject comparison of Granexin® Gel versus vehicle gel (placebo).
Vehicle gel will be applied daily over ten days. Vehicle will be applied to one of two selected target burns.
干预措施: Vehicle gel (Drug)
结局指标
主要结局
Time to re-epithelization
时间窗: From Day 0 to Month 12
Time (in days) to 100% re-epitheliazation of deep second degree burns as determined through clinical assessments
次要结局
- Proportion of subjects needing additional burn interventions(From Day 0 to Day 28)
- Time to skin grafting(From Day 0 to Month 12)
- Reduction in scar severity at Month 12(Month 12)
- Incidence of treatment related adverse events (AEs)(From Day 0 to Month 12)
- Proportion of burns that convert from partial thickness burns to full thickness burns(From Day 0 to Day 28)
- Incidence of infection(From Day 0 to Month 12)