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
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
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)
Loading locations...
相似试验
尚未招募
4 期
Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation TreatmentInfertilityNCT06571214Nanjing University300
Unknown
2 期
All-trans Retinoic Acid (ATRA) in the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and NeckAdenoid Cystic Carcinoma of the Head and NeckNCT04433169Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University30
招募中
2 期
An Open Prospective Randomized Clinical Study of the Effectiveness, Tolerability and Safety of a Single Intraperitoneal Use of the Drug "Prospidelong, Powder for the Preparation of a Gel for Topical Use, 1000 mg in Vials, Package No. 1" in Patients With Disseminated Gastric Cancer, Phase I-IIGastric Cancer With Peritoneal DisseminationNCT06232434Research Institute for Physical Chemical Problems of the Belarusian State University120
已完成
不适用
Study to Evaluate the Safety and Efficacy of HLBLS-200 in Patients Requiring Hemostatic TechniqueHemorrhageNCT03957356HLB Cell Co., Ltd.8
已完成
不适用
A Clinical Investigation to Evaluate The Orkla Corn PlasterCornsNCT04601259Orkla Care AB55