The purpose of this study is to evaluate the safety and tolerability of Lytixar™ applied topically to uncomplicated skin infections. Three dose levels of Lytixar™ (1%, 2% and 5%) versus placebo will be tested.
Treatment of uncomplicated, Gram-positive, skin infection may include application of antiseptics and desiccants, but most importantly topical antibiotics. Guidance on the use of antimicrobial therapies has been published, poor prescribing practices still exist which facilitate the development of bacterial strains resistant to available therapy. The issue of antimicrobial resistance is particularly important for Gram-positive cocci such as Staphylococcus aureus and Streptococcus pyogenes. Methicillin-resistant Staphylococcus aureus (MRSA) has been a problem for many years in the hospital setting, more recently community acquired MRSA (CA-MRSA) has emerged posing additional challenges to physicians managing skin infection. The medicinal product under development, Lytixar™, is a synthetic antimicrobial peptidomimetic agent with a membrane lysing mode of action. Lytixar™ has demonstrated activity against several Gram-positive and Gram-negative bacteria in vitro. The compound appears to be equally effective against antibiotic-resistant species such as methicillin resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococci (VRE) and multi-resistant Pseudomonas isolates. The novel membrane lysing mode of action may result in a lower propensity to the development of resistance and to date Lytixar™ demonstrates no in vitro target-specific cross-resistance with other classes of antibiotics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Topical administration. 3 times daily. 5 days.
Debreceni Egyetem Orvos-és Egészségtudományi
Debrecen, Hungary
Miskolci Semmelweis Ignác Egészegügyi Központ és
Miskolc, Hungary
Pécsi Tudományegyetem általános Orvostudom´nyi Centum
Pécs, Hungary
Szeged Univesrity Hospital
Szeged, Hungary
To determine the safety and local tolerability of topically administered Lytixar™ in patients with uncomplicated, Gram-positive, skin infection.
Tolerability and safety will be measured at Day 3, the end of treatment visit Day 7 and follow-up visits Day 14, and 21.
Time frame: After topical treatment 3 times per day 5 days
To assess the clinical and microbiological response to Lytixar™ in patients with uncomplicated, Gram-positive, skin infection. And to determine the extent of systemic absorption of Lytixar™.
Clinical outcome, changes in the Skin Infection Rating Scale (SIRS) scores from Baseline, and Bacteriological success, recurrence, failure or evaluability will be assessed at Day 3, end of treatment visit Day 7 and follow-up visits Day 14 and 21.
Time frame: Topical treatment 3 times daily for 5 days.
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