NCT01297400招募中2 期
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- Time to healing (≥95% re-epithelialization) of the partial thickness target burn.
研究概览
简要总结
To compare MW-III to Silvadene® Cream 1% (Silver Sulfadiazine) with respect to "time to healing" (≥95% re-epithelialization) of a partial thickness target thermal burn.
详细描述
This phase 2 pilot study will assess the safety and efficacy of topical MW-III on thermal burns.
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
- •Adults, 18 years of age or older on the day of signing the informed consent.
- •Thermal Burns not exceeding a total body surface area (TBSA) OF 25%, with at least one partial thickness burn of 0.5% TBSA or greater. If full thickness burn(s) are present at screening, the total full thickness burn area shall not exceed 10% TBSA. Note: TBSA excludes areas of superficial (first degree) burns.
- •Able and willing to give informed consent and comply with study procedures.
排除标准
- •Any burn that at screening is:
- •circumferential or deemed, in the judgment of the investigator, at high risk for developing compartment syndrome.
- •partial thickness that is likely, in the judgment of the Investigator, to require grafting within 72 hours, or other non-protocol intervention.
- •Severe inhalation injury or other significant non-burn trauma.
研究组 & 干预措施
Investigational Drug, MW-III
Experimental
Investigational Drug, MW-III
干预措施: Investigational Drug, MW-III (Drug)
Standard of care
Active Comparator
Silvadene® Cream 1% [Silver Sulfadiazine]
干预措施: Silvadene® Cream 1% [Silver Sulfadiazine] (Drug)
结局指标
主要结局
Time to healing (≥95% re-epithelialization) of the partial thickness target burn.
时间窗: 28 days Treatment Period
Time to healing (≥95% re-epithelialization) of the partial thickness target burn.
次要结局
- Proportion of subjects with partial thickness burns that are healed at each scheduled study assessment.(28 days Treatment Period)
- Proportion of subjects with partial thickness burns determined by PI to require skin grafting of burn wound by Day 28.(28 days Treatment Period)
- Scar scores (POSAS) of the partial thickness target burn and all other partial thickness burns at Day 28.(28 days Treatment Period)
研究者
研究点 (9)
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