A Phase IIa, Single-center, Randomized, Observer-blind Trial With Intraindividual Comparison of Treated Versus Untreated to Assess the Wound Healing Efficacy of Topical Tyrosur® Gel
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Clinical assessment of the wound healing efficacy of verum compared to untreated using a score for wound healing rates
研究概览
简要总结
This IIa study with intraindividual comparison of treated versus untreated to assess the wound healing efficacy of Tyrosur® Gel after experimental impairment of the skin using an abrasive wound healing model.
详细描述
This is a single-center, randomized, observer-blind phase IIa study with intraindividual comparison of treated versus untreated to assess the wound healing efficacy of Tyrosur® Gel after experimental impairment of the skin using an abrasive wound healing model.
In the investigation two small, superficial, abrasive wounds will be induced on the right forearm and one on the left forearm of each subject using a sterile surgical hand brush. These wounds will then be treated with the investigational products. The wound healing will be clinically assessed and photographs will be taken for documentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18 years or older with healthy skin in the test area
- •The physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant for the outcome of the clinical trial;
- •Written informed consent obtained.
排除标准
- •acne, suntan, eczema, hyperpigmentation or tattoos in the test fields;
- •dark-skinned persons whose skin color prevents ready assessment of skin reactions;
- •subjects with diabetes, psoriasis or lichen ruber planus;
- •history of wound-healing complications, or keloid and hypertrophic scarring;
- •evidence of drug or alcohol abuse;
- •pregnancy or nursing;
- •symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before and during the trial;
- •known allergic reactions to components of the investigational product/s;
- •treatment with systemic or locally acting medications which might counter or influence the trial aim within two weeks before the baseline visit (e.g. antihistamines or glucocorticosteroids);
- •contraindications according to summary of product characteristics;
研究组 & 干预措施
Verum
干预措施: Drug containing the active ingredient (Drug)
Vehicle
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical assessment of the wound healing efficacy of verum compared to untreated using a score for wound healing rates
时间窗: 12 days
次要结局
- Clinical assessment of the wound healing efficacy of the vehicle compared to untreated using a score for wound healing rates; Photo documentation of the wound healing efficacy(12 days)