NCT04417647已完成不适用
A Prospective, Randomized, Open-label, Controlled, Exploratory Trial to Investigate the Safety and Tolerability of Topically Administered VZ in Healthy Male Subjects With Artificial Dermal Wounds
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Local tolerability of IMD
研究概览
简要总结
This is a prospective, randomized, open-label, controlled, exploratory trial that aims to investigate the local skin tolerability of topically administered VZ and to evaluate efficacy and safety parameters associated with improved wound condition and healing
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects
- •Age 18-45 years at time of screening
- •Subjects are in good clinical and mental health as established by medical history and physical examination
- •Subject agrees to be compliant with study related visit and treatment schedule
- •Written informed consent
排除标准
- •Regular use of medications affecting the blood clotting process (e.g. aspirin or any other over-the-counter medicine or complimentary health product affecting the blood clotting process) or immunosuppressive drugs. Aspirin should not be taken in the 10 days prior to study participation or during the study
- •Use of topical (in the skin area of investigation) or systemic antibiotics within the last 4 weeks before study enrolment
- •History of cancer (except for non-melanoma skin cancer) within the previous 12 months or treatment with anticancer therapy (chemotherapy, immunotherapy, radiotherapy, hormone therapy for cancer treatment, targeted therapy or gene therapy) within 12 months before the first administration of investigational product or at any time during the study
- •Subjects with any known coagulation disorder
- •Subjects who have pigmented skin (Fitzpatrick Classification Level V - VI) due to an increased susceptibility to hypertrophic and keloid scarring
- •History of wound healing abnormalities or a medical condition that is known to be associated with abnormal wound healing
- •Chronic inflammatory dermatological disease
- •History of chronic autoimmune diseases such as, but not restricted to rheumatoid arthritis, inflammatory bowel disease, lupus erythematodes
- •Subjects diagnosed with Diabetes Type I or II
- •Lack of 2-point discrimination above 10 cm as assessed using an aesthesiometer
- •Tattoos, scars, burns, rashes or hyper- or hypopigmentation in the region of planned punch biopsy
- •Evidence of active infectious disease including HIV and hepatitis B or C
- •Current smoker (or any kind of nicotine consumption)
- •Known allergies to biopsy numbing medication, wound cleansing solution and wound dressing
- •Known hypersensitivity to aluminium and/or silicon
- •Allergy requiring medical treatment within the last 4 weeks prior to screening
- •Active infection or fever > 38°C within the last 7 days prior to randomization
- •Clinically relevant abnormalities in the laboratory testing, vital signs, ECG or physical examination
- •Alcohol abuse or a positive urine screen for drugs of abuse at screening
- •Participation in another clinical trial with an investigational day within the last 4 weeks before study participation
- •Employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to the sponsor
研究组 & 干预措施
Group 1
Experimental
Proximal wound SoC treatment - Distal wound VZ application
干预措施: VZ powder (purified clinoptilolite) (Device)
Group 1
Experimental
Proximal wound SoC treatment - Distal wound VZ application
干预措施: Standard of care (SoC) (Procedure)
Group 2
Experimental
Distal wound SoC treatment - Proximal wound VZ application
干预措施: VZ powder (purified clinoptilolite) (Device)
Group 2
Experimental
Distal wound SoC treatment - Proximal wound VZ application
干预措施: Standard of care (SoC) (Procedure)
结局指标
主要结局
Local tolerability of IMD
时间窗: 14 days
Local tolerability of IMD assessed using erythema severity score: a scale from 0 - 4 (0 = no visible reaction, 1 = faint, minimal erythema, 2 = erhythema, 3 = erythema with induration of vesicles, 4 = severe erythema with induration, vesicles or bullae or pustules and/ulceration) with 0 being best and 4 being worst.
次要结局
- Wound closure(1 day)
- Histological evaluation(2 days)
- Investigator's satisfaction on topical applicability(14 days)
- Adverse Events and Serious Adverse Events(28 days)
- Change in wound size(14 days)
- Wound healing and condition(14 days)
- Change in local pain intensity(14 days)
研究者
研究点 (1)
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