Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin and Superficial Subepidermal Lesions in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Tolerability of Lung Surfactant in cutaneous application measured by mean Clinical Scoring Scale for dermatitis (CSS) computed over all visits
研究概览
简要总结
Bovine Lung Surfactant is used as standard therapy for reducing alveolar surface tension in preterm infants. Here the drug is administered via airways.
The use on skin to stimulate the wound healing has not yet been tested in humans, i.e. it is not yet approved for the treatment of wound healing disorders. In the planned clinical trial Lung Surfactant is used the first time for the local treatment of skin lesions in humans. No substance related side effects were observed during the application via airways in neonates.
The innovative idea to use lung surfactant for skin wound healing derived from two observations. First, when the skin is injured, the barrier protecting the moist body surface from the dry environment is discontinued and in part lost.
Lung surfactant has several characteristics that might be beneficial for treatment of chronic cutaneous wounds.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Two healthy forearms,
- •No known chronical skin diseases,
- •Dermatoses or allergies,
- •Signed form of consent,
- •Caucasian
排除标准
- •Pregnancy or nursing period,
- •Diabetes (Type I or II),
- •Systemic or infectious diseases,
- •Skin disease,
- •Known allergies against bovine products or wound dressings,
- •Mental diseases, missing ability to consent,
- •Addictive disorders (e.g. alcohol, drugs),
- •Peripheral circulatory disorder, Morbus Raynaud,
- •Current (or < 4 weeks ago) participation in clinical trials
研究组 & 干预措施
Surfactant
Alveofact® (Bovine Lung Surfactant), 0.5 mg/ml per day (solution) all two days maximal eight times
干预措施: Surfactants (Drug)
Saline
0.9% Sodium chloride solution (NaCl solution), 2 ml per day (solution) all two days maximal eight times
干预措施: Saline Solution (Drug)
结局指标
主要结局
Tolerability of Lung Surfactant in cutaneous application measured by mean Clinical Scoring Scale for dermatitis (CSS) computed over all visits
时间窗: days 2,4,6,8,10,12,14 post baseline
次要结局
- Time to wound conclusion of wound healing and reepithelialisation: measurement of wound surface(up to 14 days and one time follow up after 30 days)
- Pain measured by mean Visual Analogue Scale over all visits(days 2,4,6,8,10,12,14 post baseline)
- TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure(day 14)
研究者
Prof. Dr. Dr. Ursula Mirastschijski
Principal Investigator
University of Bremen