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
- Conditions
- cuts, abrasions and burns
- Registration Number
- EUCTR2007-000532-47-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
· 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
2 days
· 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
· 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method