A Phase II Study to Evaluate the Efficacy and Safety of Two Doses of LTX-109 in Impetigo

Study Description

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Brief Summary:

The purpose of this study is to determine the efficacy of the topical antibiotic LTX-109 in terms of clinical and microbiological response in treatment of impetigo.

Condition or disease	Intervention/treatment	Phase
Non-bullous Impetigo	Drug: LTX-109 1 %; Drug: LTX-109 2 %; Drug: Placebo gel	Phase 2

Detailed Description:

The study will be a randomized, double-blind, placebo controlled study. Up to 210 patients will be enrolled to three treatment groups who will receive 1 % LTX-109, 2 % LTX-109 or placebo three times daily (TID) for 5 days. Patients will be randomized to receive LTX-109 or placebo at a ratio of 1:1 at each of the doses.

Patients ≥2 years with non-bullous impetigo will be enrolled in the study. Study candidacy will be determined by a dermatological examination, medical history, clinical diagnosis of non-bullous impetigo and a positive Gram-stain. Patients meeting eligibility will be randomized to one of the treatment groups.

A safety visit will be performed at Day 4. Clinical response will be evaluated by clinical success, clinical improvement or clinical failure according to definitions in the protocol at one or more of the visits - Day 4 (-1), Day 6 (+2) and Day 12 (+2), and will be derived from the Skin Infection Rating Scale (SIRS) score of the target lesion.

Bacteriological response will be evaluated by culture of swabs collected from the target lesion. Success or failure will be defined by presence or non-presence of the causative pathogen (bacteria isolated at baseline considered being the causative pathogen: S. aureus or S. pyogenes). Bacteriological swabs will be collected if pus/exudate is available at Day 4 (-1), Day 6 (+2) and Day 12 (+2), if there is exudate/pus available from the target lesion. No pus/exudate will be considered as elimination of the causative pathogen, and will be considered as bacteriological success.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	210 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Phase II, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Doses of LTX-109 (1 % and 2 %) Versus Placebo in Impetigo
Study Start Date :	February 2013
Actual Primary Completion Date :	March 2014
Actual Study Completion Date :	April 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1 % LTX-109; LTX-109 topical gel in 1 % strength	Drug: LTX-109 1 %
Experimental: 2 % LTX-109; LTX-109 topical gel in 2 % strength	Drug: LTX-109 2 %
Placebo Comparator: Placebo; Placebo gel, containing all ingredients except LTX-109	Drug: Placebo gel

Outcome Measures

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Primary Outcome Measures :

1. Efficacy of LTX-109. [ Time Frame: One year ]

   Efficacy of two doses 1% and 2% LTX-109 versus placebo will be measured by clinical response.

   Clinical response is defined as "Clinical success", "Clinical improvement" and "Clinical failure". Evaluation of the target lesion will be done at day 4, day 6 and day 12 and will be derived from Skin Infection Rating Scale (SIRS).

Secondary Outcome Measures :

1. Safety of topical administration in treatment of impetigo. [ Time Frame: One year ]

   Safety will be monitored through physical examination, compliance with assigned treatment, and recording of adverse events occurring during the study period. Changes in clinical signs and symptoms will be recorded in the SIRS score. An assessment will be done of the target lesion and one overall assessment of the subject non-target lesions. A targeted physical examination will be done if any abnormalities occur.

   For the study analysis the number of patients with adverse events and the nature of the adverse events will be listed per treatment group.

2. Microbiological response of two doses of LTX-109 (1% and 2%) versus placebo in the treatment of impetigo. [ Time Frame: One year ]
   Microbiological response will be measured by "Bacteriological Success" or "Bacteriological failure". The response will be derived from bacterial swab cultures, and presence or non-presence of the causative pathogen at each of the follow up visits, day 4, day 6, and day 12.

Eligibility Criteria

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Ages Eligible for Study:	2 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Patients ≥ 2 years of age.
• Signed written informed consent document by patient, parent, legal guardian or caretaker.
• Positive Gram-stain of target lesion showing Gram-positive cocci.
• Clinical diagnosis of primary non-bullous impetigo as per protocol.
• Candidate for treatment with topical antibacterial and have a Skin Infection Rating Scale (SIRS) of ≥ 4 with at least three of the five primary signs and symptoms present at baseline including a score of 1 or greater for exudate/pus.
• Total lesion area ≤ 20 cm2. Single lesion not to exceed 2 cm2.
• No known medical conditions that in the investigators opinion may interfere with study participation or put the patient at additional risk.

Exclusion Criteria:

• Unwillingness or inability of patient, parent, legal guardian or caretaker to comply with the requirements of the protocol.
• Presence of other skin disease at or near the investigational target area to be treated.
• The disease is so widespread or severe that, in the opinion of the investigator, the patient needs oral antibiotic treatment.
• History of hepatitis B or C, HIV, AIDS, or other immunodeficiency disease.
• Concurrent or recent scabies infection.
• Signs and symptoms of a current infection requiring antibiotic treatment.
• Tympanic temperature at Baseline > 38 °C (100.4 °F) in a pediatric patient or 37.8 °C (100 °F) in an adult patient.
• Use of systemic or topical antibiotics or steroids within 72 hours prior to study entry.
• Participation in any other clinical study or use of any other investigational drugs or investigational device within 30 days prior to treatment.
• Known allergy to any constituent of the study medication.
• Presence of secondarily-infected animal/human/insect bite or infected burn wound.
• Other reason which based on the discretion of the investigator makes the patient unsuitable for enrolment.
• Lactating or pregnant.

Contacts and Locations

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Locations

Dominican Republic
Dr. Robert Reid Cabral Children Hospital
Santo Domingo, Dominican Republic
Institute of Dermatology and and Skin Surgery Dr. Hubert Bogaert Diaz
Santo Domingo, Dominican Republic

Sponsors and Collaborators

Lytix Biopharma AS

Investigators

Principal Investigator:	Daisy M Blanco, MD	Institute of Dermatology and Skin Surgery, Dr. Hubert Bogaert Diaz, Santo Domingo
Principal Investigator:	Josefina Fernandez, MD	Dr. Robert Reid Cabral Children hospital, Santo Domingo

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Lytix Biopharma AS
ClinicalTrials.gov Identifier:	NCT01803035 History of Changes
Other Study ID Numbers:	C12-109-04
First Posted:	March 4, 2013
Last Update Posted:	April 28, 2014
Last Verified:	April 2014

Keywords provided by Lytix Biopharma AS:

Impetigo; LTX-109; Topical; Antibiotic	Placebo; Lytic; Peptide; Gram Positive

Additional relevant MeSH terms:

Impetigo; Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections	Streptococcal Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Infection; Skin Diseases