NCT01223222

A Study to Evaluate Safety, Tolerability and Efficacy of Lytixar™ (LTX-109) on Uncomplicated, Gram-positive, Skin Infection

A Randomised, Double-blind, Placebo-controlled, Phase IIa Pilot Study to Evaluate the Safety, Tolerability and Efficacy of Lytixar™ (LTX-109) in Patients With Uncomplicated, Gram-positive, Skin Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Lytix Biopharma AS · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gram-positive, Skin Infections
• Mild Eczema/Dermatoses
• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	LTX-109	Topical administration. 3 times daily. 5 days.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-10-18
• Last updated: 2011-02-16

Locations

4 sites across 1 country: Hungary