EUCTR2007-000532-47-DE进行中（未招募）不适用
Singleblind, randomized, verum-controlled, multicentric study to confirm the non-inferiority of Leukichtan Gel versus Betaisodona Salbe in the treatment of cuts, abrasions and burns
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •· age: 7 months - 80 years
- •· male or female Caucasians
- •· voluntary participation in the study
- •· existence of a written consent of the patient, for patients under 18 years of age
- •additionally with signature of a legal representative
- •· diagnosis: superficial, fresh cuts, abrasions or burns, grade I-II, not older than
- •· Safe contraception (female patients) according to Pearl Index < 1 - fulfilled as
- •follows: (one of the following items has to be answered with yes”)
- •- hormonal contraception via estrogens and progestogens for example:
- •oCombined hormonal contraceptive pill (estrogens and progestogens)
- •oMini pill(progestogens only)
- •oContraceptive vaginal ring(ring with estrogens and progestogens)
- •oContraceptive Patch(estrogens and progestogens)
- •oIntrauterine systems (IUS)(with progestogens)
- •- sterilisation
- •- Sexual abstinence (reliable statement) / vasectomised partner
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •· injuries older than 2 days (corresponding to 48 hours)
- •· cuts > 10 cm, abrasions or burns > 100 cm2
- •· severe concomitant diseases (i.e. liver-/kidney disorders, metabolism disorders,
- •tumors in the anamnesis)
- •· hyperthyreosis or other manifest thyroid disease
- •· dermatitis herpetiformis Duhring
- •· patient was or will be treated before or after the study with a radio-iodine-therapy
- •· patient with bland adenomatous goiter
- •· predisposed patient with autonomic adenomas resp. functional autonomy
- •· known hypersensitivity / allergy against iodine or Sodium bituminosulfonate, pale or
- •one of the other ingredients of the investigational product
- •· simultaneous application of enzymatic wound treatment
- •· simultaneous application of hydrogen peroxide and Taurolidin as well as disinfectants
- •containing silver or wound dressings containing silver (formation of silver iodide)
- •· simultaneous or shortly subsequent treatment with disinfectants containing
- •quicksilver (risk of chemical burn due to formation of quicksilver iodide)
- •· existence of diseases that require systemic application of antibiotics or steroids
- •and/or topical administration of antibiotics or steroids in the area of the skin injury
- •· oral and/or topical therapy with corticosteroids
- •· application of other medicinal and/or cosmetical products that can influence the
- •therapy during the study
- •· alcohol, drugs or medicins abuse
- •· physical or psycological diseases where the adherence to the protocol
- •appears to be questionable
- •· lacking compliance
- •· pregnancy, lactation
- •· first-time intake of hormonal contraceptives or change of contraceptives within the
- •last 3 months
- •· participation in another clinical trial within the last 30 days, planned participation
- •in another clinical trial within the duration of this study
- •· previous participation within this study
研究者
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