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

NCT ID: NCT01223222

Last Updated: 2011-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1% Lytixar™

6 subjects will be treated with Lytixar™ and 2 will be treated with vehicle (placebo).

Group Type: PLACEBO_COMPARATOR

LTX-109

Intervention Type: DRUG

Topical administration. 3 times daily. 5 days.

2% Lytixar™

6 subjects will be treated with Lytixar™ and 2 will be treated with vehicle (placebo).

Group Type: ACTIVE_COMPARATOR

LTX-109

Intervention Type: DRUG

Topical administration. 3 times daily. 5 days.

5% Lytixar™

6 subjects will be treated with Lytixar™ and 2 will be treated with vehicle (placebo).

Group Type: ACTIVE_COMPARATOR

LTX-109

Intervention Type: DRUG

Topical administration. 3 times daily. 5 days.

Interventions

LTX-109

Topical administration. 3 times daily. 5 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female patients between the ages of 18 and 65, inclusive.
• Diagnosis of uncomplicated, Gram-positive, skin infection. This may include patients with mild eczema/dermatoses such as atopic dermatitis.
• Gram-positive organisms determined at Baseline (Day 1) which in the opinion of the investigator are causative for infection of the lesion(s).

Candidate for treatment with topical antibacterial therapy:

• area to be treated ≤100 cm2
• SIRS score of at least 8 for the area of study medication application

• Female patients of child bearing potential and male patients with female partners of child-bearing potential must be willing to use an adequate barrier form of contraception, (i.e., diaphragm or condom with spermicidal agent) prior to entry into the study and for two weeks following the completion of all follow-up procedures. Hormonal contraception or hormonal IUDs alone are not considered to be acceptable forms of contraception.
• Provision of signed and dated written informed consent by the patient.
• Patient's medical condition is stable, with no other clinically significant abnormalities as determined by the investigator.
• Patients must be able to understand the written patient information and the consent form, and be willing to return to the study site for follow up visits, comply with requirements, instructions and restrictions of the study as listed in the informed consent form.

Exclusion Criteria

• Moderate to Severe dermatoses including but not limited to psoriasis, atopic dermatitis or eczema.
• Secondarily-infected animal/human bite, puncture wound or abscess.
• Chronic ulcerative lesions.
• Bacterial skin infection which, due to the area, depth or severity, in the opinion of the investigator, cannot be appropriately treated by a topical antibiotic.
• More than one type of infected lesion.
• Surgical intervention is required for treatment of the infection prior to enrolment in the study, or such intervention is likely to be required during the course of the study.
• Application of any topical pharmaceutical agent (including but not limited to, corticosteroids, antibacterials, antiseptics or antifungal agents) directly to the infected wound/lesion(s), within 72 hours prior to study entry.
• Systemic signs or symptoms of infection (such as fever).
• Treatment for one or more days with a systemic antibacterial agent within 72 hours of study entry.
• Ongoing treatment with systemic corticosteroids at a dose of >0.125mg/kg per day of prednisone (or the equivalent).
• Known, pre-existing or serious underlying disease that could be imminently life-threatening.
• Pregnancy or ongoing lactation.
• Participation in any study using an investigational drug or device during the previous 30 days prior to entering the study.
• Significant ongoing or history of drug or alcohol abuse which in the opinion of the investigator makes the patient unsuitable for enrolment.
• Known allergic reactions or hypersensitivity of significant severity in general and specifically to any component of the study medication.
• Current or history of significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, haematological, or metabolic disorder that is not in a stable condition. Malignancy <5 years since last treatment (resolved basal cell carcinoma is permitted).
• Current or history of any significant disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
• Other unspecified reasons that, in the opinion of the investigator make the Patient unsuitable for enrolment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lytix Biopharma AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Lytix Biopharma AS

Principal Investigators

Lajos Kemeny, DSc, Prof

Role: PRINCIPAL_INVESTIGATOR

St. George Albert Clinic Zeged University Hospital

Locations

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

Countries

Hungary

Other Identifiers

C10-109-03

Identifier Type: -

Identifier Source: org_study_id