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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
Hungary
Study Type
Interventional
Intervention
LTX-109
Sponsored by
Lytix Biopharma AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gram-positive, Skin Infections focused on measuring Uncomplicated skin infections, Impetigo, Gram-negative, Diagnosis of uncomplicated, Gram-positive, skin infection. This may include patients with mild eczema/dermatoses such as atopic dermatitis., Gram-positive organisms which in the opinion of the investigator are causative for infection of the lesion(s),

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Debreceni Egyetem Orvos-és Egészségtudományi
  • Miskolci Semmelweis Ignác Egészegügyi Központ és
  • Pécsi Tudományegyetem általános Orvostudom´nyi Centum
  • Szeged Univesrity Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

1% Lytixar™

2% Lytixar™

5% Lytixar™

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 14, 2010
Last Updated
February 15, 2011
Sponsor
Lytix Biopharma AS
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1. Study Identification

Unique Protocol Identification Number
NCT01223222
Brief Title
A Study to Evaluate Safety, Tolerability and Efficacy of Lytixar™ (LTX-109) on Uncomplicated, Gram-positive, Skin Infection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lytix Biopharma AS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram-positive, Skin Infections, Mild Eczema/Dermatoses, Atopic Dermatitis
Keywords
Uncomplicated skin infections, Impetigo, Gram-negative, Diagnosis of uncomplicated, Gram-positive, skin infection. This may include patients with mild eczema/dermatoses such as atopic dermatitis., Gram-positive organisms which in the opinion of the investigator are causative for infection of the lesion(s),

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1% Lytixar™
Arm Type
Placebo Comparator
Arm Description
6 subjects will be treated with Lytixar™ and 2 will be treated with vehicle (placebo).
Arm Title
2% Lytixar™
Arm Type
Active Comparator
Arm Description
6 subjects will be treated with Lytixar™ and 2 will be treated with vehicle (placebo).
Arm Title
5% Lytixar™
Arm Type
Active Comparator
Arm Description
6 subjects will be treated with Lytixar™ and 2 will be treated with vehicle (placebo).
Intervention Type
Drug
Intervention Name(s)
LTX-109
Intervention Description
Topical administration. 3 times daily. 5 days.
Primary Outcome Measure Information:
Title
To determine the safety and local tolerability of topically administered Lytixar™ in patients with uncomplicated, Gram-positive, skin infection.
Description
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
Secondary Outcome Measure Information:
Title
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™.
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lajos Kemeny, DSc, Prof
Organizational Affiliation
St. George Albert Clinic Zeged University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Debreceni Egyetem Orvos-és Egészségtudományi
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Miskolci Semmelweis Ignác Egészegügyi Központ és
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Pécsi Tudományegyetem általános Orvostudom´nyi Centum
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Szeged Univesrity Hospital
City
Szeged
ZIP/Postal Code
6720
Country
Hungary

12. IPD Sharing Statement

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

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