Clinical Trial: A Phase II Study to Evaluate the Efficacy and Safety of Two Doses of LTX-109 in Impetigo

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Lytix Biopharma AS

Current Primary Outcome: Efficacy of LTX-109. [ Time Frame: One year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Safety of topical administration in treatment of impetigo. [ Time Frame: One year ]

  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 ]
  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.

Original Secondary Outcome: Same as current

Information By: Lytix Biopharma AS

Dates:
Date Received: February 21, 2013
Date Started: February 2013
Date Completion:
Last Updated: April 25, 2014
Last Verified: April 2014