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

NCT ID: NCT01803035

Last Updated: 2014-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-04-30

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.

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.

Conditions

Non-bullous Impetigo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1 % LTX-109

LTX-109 topical gel in 1 % strength

Group Type: EXPERIMENTAL

LTX-109 1 %

Intervention Type: DRUG

2 % LTX-109

LTX-109 topical gel in 2 % strength

Group Type: EXPERIMENTAL

LTX-109 2 %

Intervention Type: DRUG

Placebo

Placebo gel, containing all ingredients except LTX-109

Group Type: PLACEBO_COMPARATOR

Placebo gel

Intervention Type: DRUG

Interventions

LTX-109 1 %

Intervention Type: DRUG

LTX-109 2 %

Intervention Type: DRUG

Placebo gel

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lytix Biopharma AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daisy M Blanco, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Dermatology and Skin Surgery, Dr. Hubert Bogaert Diaz, Santo Domingo

Josefina Fernandez, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. Robert Reid Cabral Children hospital, Santo Domingo

Locations

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

Countries

Dominican Republic

Other Identifiers

C12-109-04

Identifier Type: -

Identifier Source: org_study_id