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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2010-021438-68-HU
• Date of registration: 06/07/2010
• Prospective Registration: Yes
• Primary sponsor: Lytix Biopharma AS
• Public 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
• Scientific 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
• Date of first enrolment: 18/08/2010
• Target sample size: 35
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021438-68
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Hungary

Key inclusion & exclusion criteria

Inclusion criteria:
1) Male and female patients between the ages of 18 and 65, inclusive.
2) Diagnosis of uncomplicated, Gram-positive, skin infection. This may include patients with mild eczema/dermatoses such as atopic dermatitis.
3) Gram-positive organisms determined at Baseline (Day 1) which in the opinion of the investigator are causative for infection of the lesion(s).
4) Candidate for treatment with topical antibacterial therapy:
a. area to be treated =100 cm2
b. SIRS score of at least 8 for the area of study medication application
5) 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.
6) Provision of signed and dated written informed consent by the patient.
7) Patient’s medical condition is stable, with no other clinically significant abnormalities as determined by the investigator.
8) 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1) Moderate to Severe dermatoses including but not limited to psoriasis, atopic dermatitis or eczema.
2) Secondarily-infected animal/human bite, puncture wound or abscess.
3) Chronic ulcerative lesions.
4) 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.
5) More than one type of infected lesion.
6) 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.
7) 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.
8) Systemic signs or symptoms of infection (such as fever).
9) Treatment for one or more days with a systemic antibacterial agent within 72 hours of study entry.
10) Ongoing treatment with systemic corticosteroids at a dose of >0.125mg/kg per day of prednisone (or the equivalent).
11) Known, pre-existing or serious underlying disease that could be imminently life-threatening.
12) Pregnancy or ongoing lactation.
13) Participation in any study using an investigational drug or device during the previous 30 days prior to entering the study.
14) Significant ongoing or history of drug or alcohol abuse which in the opinion of the investigator makes the patient unsuitable for enrolment.
15) Known allergic reactions or hypersensitivity of significant severity in general and specifically to any component of the study medication.
16) 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).
17) Current or history of any significant disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
18) Other unspecified reasons that, in the opinion of the investigator make the Patient unsuitable for enrolment.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Uncomplicated, Gram-positive skin infections
MedDRA version: 12.1 Level: LLT Classification code 10040872 Term: Skin infection

Intervention(s)

Product Name: Lytixar
Product Code: LTX-109
Pharmaceutical Form: Gel
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: LTX-109
Other descriptive name: LTX-9
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Cutaneous use

Product Name: Lytixar
Product Code: LTX-109
Pharmaceutical Form: Gel
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: LTX-109
Other descriptive name: LTX-9
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 2-

Product Name: Lytixar
Product Code: LTX-109
Pharmaceutical Form: Gel
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: LTX-109
Other descriptive name: LTX-9
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Secondary Objective: • To make an assessment of the clinical and microbiological response to Lytixar™ when administered three times per day for five days in patients with uncomplicated, Gram-positive, skin infection

• To determine the extent of systemic absorption of Lytixar™ when administered three times per day for five days in patients with uncomplicated, Gram-positive, skin infection

Primary end point(s): • Safety and tolerability will be evaluated via recording of adverse events, clinical signs and symptoms and clinical laboratory abnormalities.

Main Objective: • To determine the safety and local tolerability of topically administered Lytixar™ in patients with uncomplicated, Gram-positive, skin infection

Secondary ID(s)

C10-109-03