Patients with burn injuries confined to the trunk and/or upper and lower extremities. Total burn area for all burns on a single patient should be no greater than 15% of TBSA. Patients’ total study target burn area (deep second-degree) should be greater than 50 cm2 but no greater than 200 cm2 (or 1% of TBSA).
Conditions
Interventions
Product Name: Kék Lukács Ointment
Pharmaceutical Form: Cream
INN or Proposed INN: AZITHROMYCIN
CAS Number: 83905-01-5
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration
Sponsors
Lukács és Társa Gyógyszerkereskedelmi Betéti Társaság
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent by the patient 2. Male and female patients aged between 18 and 65 years 3. Female patients with childbearing potential with a negative result from pregnancy test at inclusion, who agrees to use an acceptable birth control method (hormonal or IUD) or abstinence throughout the trial 4. Thermal origin burns 5. Total burn area for all burns on a single patient should be no greater than 15% of TBSA 6. Patients with burn injuries confined to the trunk and/or upper and lower extremities 7. Patients’ total study target burn area (second-degree) should be greater than 50 cm2 but no greater than 200 cm2 (or 1% of TBSA). 8. Patients with fresh (burn therapy started less than 24 hours post burn) second-degree burns (deep or mixed deep and superficial partial thickness burns). 9. Patients with non recent second-degree burns (burn therapy started later than 24 but not later than 36 hours post-burn). 10. Able to communicate well with the investigator and comply with the study requirements Are the trial subjects under 18? no 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. Patients with significant co-morbid conditions like chronic respiratory illness, ischemic or other cardiac disease and/or diabetes, immunodeficiency. 2. Patients with inhalation injury. 3. Burns >15% TBSA. 4. Patients with known or suspected allergy to any of the components of Kék Lukács ointment or SSD cream. 5. Head, genitalia, palms of hands, soles of feet and face are excluded as test sites. 6. Circumferential burns 7. Electrical and/or chemical burns. 8. Clinically significant systemic infections requiring systematic antibiotic treatment. 9. Patients with vascular or skin disorders that directly affect the designated wound site. 10. Any other acute or chronic concurrent medical conditions that in the Investigator’s opinion compromise study participation. 11. Lactation, pregnancy or women of childbearing potential not practicing an adequate method of contraception. 12. Participation in a clinical trial within 30 days before start of the trial. 13. History of drug and/or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the clinical efficacy of Kék Lukács ointment treatment with standard silver sulphadiazine (SSD) therapy in wound healing; degree of epithelisation of wound until Day 22 of treatment compared to Day 1. ;Secondary Objective: 1. Investigator‘s assessment of signs of wound infection and inflammation. 2. Assess the wound bed and wound margin. 3. Compare the effect of Kék Lukács ointment treatment and SSD therapy on bacterial load. 4. Assess the degree of epithelisation of wound. 5. Assess the tolerability of local therapy of target wound based on sensitivity and local irritability on every day during treatment. 6. Evaluate the satisfaction of cosmetic result: general wound appearance and effect on crusting and scabbing after Kék Lukács ointment treatment comparing to SSD treatment. 7. Reach eligibility to skin transplantation if needed. 8. Assess the ease of application of Kék Lukács ointment; evaluating pain at application and at dressing changes at every visit. 9. Pharmacokinetic analysis will be performed of Kék Lukács treated patients to assess the plasma levels of sulfamethoxazole, azithromycin, and miconazole. 10. Collect pharmacoeconomic information.;Primary end point(s): Percent of reduction in wound surface area from Day 1 to Day 22 (3 weeks after treatment start).;Timepoint(s) of evaluation of this end point: Day 1 to Day 22 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Incidence of complete wound healing full epithelisation within 22 days. 2. Time to complete wound healing if full epithelisation occurs within 22 days. 3. Percent reduction of wound surface area, on Day 8, 15 and 22 from Day 1. 4. Incidence of treatment failure defined as less than 30% decrease in wound size after 22 days treatment. 5. Incidence of eligibility to skin transplantation after treatment of Kék Lukács ointment if needed. 6. To assess the ease of application of Kék Lukács ointment; evaluating pain at application and at dressing changes at every visit.;Timepoint(s) of evaluation of this end point: Day 1 to Day 22 | — |
Countries
Hungary
Contacts
Public ContactKÉKLUKÁCS Help Desk
AdWare Research Ltd.?
Outcome results
None listed