Non-bullous Impetigo Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 210 |
| Est. completion date | April 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Lytix Biopharma AS |
Dominican Republic,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). |
One year | No |
| Secondary | 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. |
One year | No |
| Secondary | 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. | One year | No |