Clinical trial NCT01223222 (phase 2, status: completed)
Conditions: gram-positive, skin infections, mild eczema/dermatoses, atopic dermatitis
ICD codes: L20.89, L20.9
Drugs: ltx-109
SMILES: CC(C)(C)C1=C(C[C@H](NC(=O)[C@@H](N)CCCNC(N)=N)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCCC2=CC=CC=C2)C2=CC(=CC(=C2N1)C(C)(C)C)C(C)(C)C
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.