A Randomized, Double-blind, Single Center, Intra-individual Comparison Study With Repeated Application to Assess the Wound-healing Efficacy of a 5% Dexpanthenol Ointment Compared With Placebo in Patients With Superficial, Abrasive Wounds
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 28
- 主要终点
- Wound healing effect (=re-epithelization) at Day 5 of the test product and the placebo
研究概览
简要总结
The objective of the study was to investigate the efficacy of Bepanthen® wound healing ointment compared to placebo in a superficial abrasive wound model. The primary objective was the re-epithelization at Day 5.
The secondary objectives were re-epithelization at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15, assessment of cosmetic outcome/acceptance at Day 15 (investigator only) and at Day 36 (investigator and subject), and documentation and analysis of safety parameters.
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
- 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
- •Healthy Caucasian subjects of both genders, 18 to 45 years of age, Fitzpatrick skin type I to IV
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
- •History of plaster sensitivity
- •Intake of drugs interfering with the immune system within 30 days before day 1 as well as during the study
- •Concomitant therapy with substances affecting blood coagulation within up to 14 days prior to the start of the study as well as during the study
- •Any condition or treatment which might influence the study
- •Change of hormonal contraception within 3 months prior to enrolment and during the study
- •Application of any topical treatment at the test areas during the conduct of the study
- •Intensive ultraviolet-light exposure within two weeks before the beginning as well as during the study
- •Removal of axillary lymph nodes
- •Allergy to the ingredients of the test product
- •Pregnancy or lactation
- •Any illness on account of which the subject should not participate in the study in the opinion of the investigator
- •Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing
- •Any history of drug addiction or alcoholism in the past 3 years
- •Infectious diseases (e.g. hepatitis or AIDS)
研究组 & 干预措施
Dexpanthenol
A squeeze of ointment, approximately 0.5 cm in length corresponding to an amount of about 0.3 g of ointment, which is equal to 15 mg dexpanthenol , twice daily (once in the morning and once in the evening) over a period of 14 days was applied topically under occluded conditions
干预措施: Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996) (Drug)
Placebo
Subjects received applications of placebo corresponding to verum
干预措施: Placebo (Drug)
结局指标
主要结局
Wound healing effect (=re-epithelization) at Day 5 of the test product and the placebo
时间窗: At Day 5
Wound healing effect (=re-epithelization) was determined on the following basis: No healing 0% Re-epithelization \>0 up to 25% Re-epithelization \>25 up to 50% Re-epithelization \>50 up to 75% Re-epithelization \>75 but not complete Complete closure of surface 100%
次要结局
- Subjective assessment of cosmetic outcome(At Days 15 and 36)
- Number of participants with adverse events(Approximately 5 weeks per subject)
- Wound healing at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15 after wound induction(At Days 2, 3, 4, 6, 7, 8, 9, 10 and 15)