Status:
COMPLETED
A Phase II Study to Evaluate the Efficacy and Safety of Two Doses of LTX-109 in Impetigo
Lead Sponsor:
Lytix Biopharma AS
Conditions:
Non-bullous Impetigo
Eligibility:
All Genders
2+ years
Phase:
PHASE2
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01803035
Start Date
February 1 2013
End Date
April 1 2014
Last Update
April 28 2014
Active Locations (2)
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1
Dr. Robert Reid Cabral Children Hospital
Santo Domingo, Dominican Republic
2
Institute of Dermatology and and Skin Surgery Dr. Hubert Bogaert Diaz
Santo Domingo, Dominican Republic