cuts, abrasions and burns
Conditions
Interventions
Trade Name: Leukichtan Gel
Pharmaceutical Form: Gel
INN or Proposed INN: Sodium Bituminosulfonate
CAS Number: 1340-06-3
Other descriptive name: Natriumbituminosulfonate, hell
Concentration unit: % (W/
Sponsors
ICHTHYOL-GESELLSCHAFT Cordes, Hermanni & Co. (GmbH & Co.) KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Confirmation of the non-inferiority of Leukichtan Gel versus Betaisodona Salbe in the treatment of superficial skin injuries (cuts, abrasions and burns) measured as amount of patients with complete epithelisation of the wound during the treatment period. ;Secondary Objective: a) Confirmation of the non-inferiority of Leukichtan Gel versus Betaisodona Salbe in the treatment of skin injuries (cuts, abrasions and burns) measured as - amount of patients with complete granulation of the wound - enlargement of the granulated area of the wound - time until the complete epithelisation of the wound - wound infection, erythema, fibrin coating - pain evaluation by investigator and by patient (from the age of 5 years) via patient's questionnaire at every visit - evaluation of therapy success by investigator and by patient (from 5 years) via patient's questionnaire at every visit - over all evaluation of therapy success by investigator at the end of study b) the comparability of tolerance At study start and at every visit, the tolerance of therapy will be evaluated by investigator and by patient (from 5 years) via patient's questionnaire. Furthermore, investigator evaluates the over all tolerance at the end of study.;Primary end point(s): visite 4 = final examination after 14 days treatment | — |
Countries
Germany
Outcome results
None listed