A Phase II Study to Evaluate the Efficacy and Safety of Two Doses of LTX-109 in Impetigo
Drug: LTX-109 1 %
Drug: LTX-109 2 %
Drug: Placebo gel
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- Efficacy of LTX-109. [ Time Frame: One year ] [ Designated as safety issue: No ]
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).
- Safety of topical administration in treatment of impetigo. [ Time Frame: One year ] [ Designated as safety issue: No ]
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. [ Time Frame: One year ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2013|
|Study Completion Date:||April 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01803035
|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|
|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|