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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment