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

NCT01223222 | Completed Phase 2

• 1 other identifier: C10-109-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

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.

Conditions

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),

Outcome Measures

Primary Outcomes (1)

• 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.

  After topical treatment 3 times per day 5 days

Secondary Outcomes (1)

• 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™.

  Topical treatment 3 times daily for 5 days.

Study Arms (3)

1% Lytixar™

PLACEBO COMPARATOR

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

Drug: LTX-109

2% Lytixar™

ACTIVE COMPARATOR

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

Drug: LTX-109

5% Lytixar™

ACTIVE COMPARATOR

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

Drug: LTX-109

Interventions

LTX-109 DRUG

Topical administration. 3 times daily. 5 days.

1% Lytixar™; 2% Lytixar™; 5% Lytixar™

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lytix Biopharma AS: lead

Study Sites (4)

Debreceni Egyetem Orvos-és Egészségtudományi

Debrecen, 4032, Hungary

Location

Miskolci Semmelweis Ignác Egészegügyi Központ és

Miskolc, 3529, Hungary

Location

Pécsi Tudományegyetem általános Orvostudom´nyi Centum

Pécs, 7624, Hungary

Location

Szeged Univesrity Hospital

Szeged, 6720, Hungary

Location

MeSH Terms

Conditions

Cellulitis; Skin Diseases; Dermatitis, Atopic; Impetigo

Interventions

L-arginyl-2,5,7-tris(1,1-dimethylethyl)-L-tryptophyl-N-(2-phenylethyl)-L-argininamide

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Skin Diseases, Bacterial

Study Officials

• Lajos Kemeny, DSc, Prof

  St. George Albert Clinic Zeged University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 16, 2011

Record last verified: 2011-02

Locations

HU (4)