NCT00859196已完成4 期
A Randomized, Double-blind, Single Centre, Placebo-controlled Pilot Study to Assess on a Molecular Level the Influence of a 5 % Dexpanthenol Ointment in Subjects With Previously Injured Skin by Investigation of Skin Biopsies
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 15
- 主要终点
- Investigation of gene expression in dermal fibroblasts and keratinocytes on a molecular level.
研究概览
简要总结
In previous in vitro studies it could be shown, that Dexpanthenol has an influence on the gene expression of fibroblasts. The genes which are influenced by Dexpanthenol play mainly a role during cell proliferating processes.The aim of this study is to investigate the molecular effect of Dexpanthenol on human living skin, during wound healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Skin type I to IV
- •Willingness to avoid intensive sunlight exposure two weeks before the start of the study and at least 2 months after removal of the stitches
排除标准
- •Active skin disease, moles, tattoos, strong pigmentation at the test area or scars in the test area that would influence the visual scoring
- •History of keloids and hypertrophic scars
- •Frequent visits of tanning booths
- •Intake of drugs interfering with the immune system (e.g. antiphlogistics, corticosteroids, immunosuppressants, and antihistamines) within 30 days before day 1 as well as during the study.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Dexpanthenol (BAY81-2996) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Investigation of gene expression in dermal fibroblasts and keratinocytes on a molecular level.
时间窗: Analysis of skin biopsies taken 24h, 72h and 144h after wounding
次要结局
未报告次要终点
研究者
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