Clinical Trial to Assess the Safety and Efficacy of Kék Lukács Ointment in Treating Wound-healing of Patients With Deep Partial Thickness Burns

• Conditions: 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).; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-005037-39-HU
• Lead Sponsor: ukács és Társa Gyógyszerkereskedelmi Betéti Társaság

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-03
• Last Update Posted: 9 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified