Back to resultsA Phase II Study to Evaluate the Efficacy and Safety of Two Doses of LTX-109 in Impetigo
Primary Purpose
Non-bullous Impetigo
Status
Completed
Phase
Phase 2
Locations
Dominican Republic
Study Type
Interventional
Intervention
LTX-109 1 %
LTX-109 2 %
Placebo gel
Sponsored by
About this trial
This is an interventional treatment trial for Non-bullous Impetigo focused on measuring Impetigo, LTX-109, Topical, Antibiotic, Placebo, Lytic, Peptide, Gram Positive
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.
Sites / Locations
- Dr. Robert Reid Cabral Children Hospital
- Institute of Dermatology and and Skin Surgery Dr. Hubert Bogaert Diaz
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1 % LTX-109
2 % LTX-109
Placebo
Arm Description
LTX-109 topical gel in 1 % strength
LTX-109 topical gel in 2 % strength
Placebo gel, containing all ingredients except LTX-109
Outcomes
Primary Outcome Measures
Efficacy of LTX-109.
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
Safety of topical administration in treatment of impetigo.
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.
Microbiological response of two doses of LTX-109 (1% and 2%) versus placebo in the treatment of impetigo.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01803035
Brief Title
A Phase II Study to Evaluate the Efficacy and Safety of Two Doses of LTX-109 in Impetigo
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 Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lytix Biopharma AS
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-bullous Impetigo
Keywords
Impetigo, LTX-109, Topical, Antibiotic, Placebo, Lytic, Peptide, Gram Positive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 % LTX-109
Arm Type
Experimental
Arm Description
LTX-109 topical gel in 1 % strength
Arm Title
2 % LTX-109
Arm Type
Experimental
Arm Description
LTX-109 topical gel in 2 % strength
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo gel, containing all ingredients except LTX-109
Intervention Type
Drug
Intervention Name(s)
LTX-109 1 %
Intervention Type
Drug
Intervention Name(s)
LTX-109 2 %
Intervention Type
Drug
Intervention Name(s)
Placebo gel
Primary Outcome Measure Information:
Title
Efficacy of LTX-109.
Description
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).
Time Frame
One year
Secondary Outcome Measure Information:
Title
Safety of topical administration in treatment of impetigo.
Description
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.
Time Frame
One year
Title
Microbiological response of two doses of LTX-109 (1% and 2%) versus placebo in the treatment of impetigo.
Description
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.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daisy M Blanco, MD
Organizational Affiliation
Institute of Dermatology and Skin Surgery, Dr. Hubert Bogaert Diaz, Santo Domingo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Josefina Fernandez, MD
Organizational Affiliation
Dr. Robert Reid Cabral Children hospital, Santo Domingo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Robert Reid Cabral Children Hospital
City
Santo Domingo
Country
Dominican Republic
Facility Name
Institute of Dermatology and and Skin Surgery Dr. Hubert Bogaert Diaz
City
Santo Domingo
Country
Dominican Republic
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study to Evaluate the Efficacy and Safety of Two Doses of LTX-109 in Impetigo
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