Impetigo MedDRA version: 7.1 Level: PT Classification code 10021531
Conditions
Sponsors
GlaxSmithKline Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. The subject is greater than or equal to 9 months of age. 2. The subject has a clinical diagnosis of primary impetigo (bullous and non-bullous) defined as follows: A lesion or a group of lesions characterised by red spots or blisters without crusts which later progress to lesions which ooze and form yellow or honey-coloured crusts surrounded by an erythematous margin. 3. The subject has no more than 10 discrete localised impetigo lesions suitable for topical treatment. 4. The infected lesion(s) should not exceed 100 cm2 in area with surrounding erythema not extending more than 2 cm from the edge of any lesion or up to a maximum of 2% body surface area for subjects =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. The subject has demonstrated a previous hypersensitivity reaction to sodium fusidate or to any component of the ointment (refer to the prescribing information for composition of the sodium fusidate ointment), or the subject has demonstrated a previous hypersensitivity reaction to pleuromutilin or any component of the ointment (refer to the Investigator Brochure for composition of SB-275833 ointment). 2. The subject has an underlying skin disease (e.g., pre-existing eczematous dermatitis) or skin trauma, with clinical evidence of secondary infection. 3. The subject has signs and symptoms of systemic infection (such as fever, defined as an oral temperature greater than 101° F or 38.3° C). 4. The subject has a bacterial skin infection which, due to depth or severity, in the opinion of the investigator, cannot be appropriately treated by a topical antibiotic. Examples include extensive cellulitis, furunculosis and abscess. 5. The subject has received a systemic antibacterial, steroid, or has applied any topical therapeutic agent (including glucocorticoid steroids, antibacterials and antifungals) directly to the impetigo lesion(s), less than 24 hours prior to study entry. 6. The subject has a serious underlying disease that could be imminently life threatening. 7. The subject is pregnant, breast-feeding or planning a pregnancy during the study. 8. The subject has used an investigational drug within 30 days prior to entering the study. 9. The subject has been previously enrolled in this study or in any other study involving SB-275833. During the study period, the infected lesion(s) may only be treated with the topical agent to which the subject was randomised, i.e. 1% SB-275833 ointment or 2% sodium fusidate ointment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy and safety of topical applications of 1% SB-275833 ointment given for 5 days with topical 2% sodium fusidate ointment given for 7 days, in the treatment of impetigo in adult and paediatric subjects.;Secondary Objective: ;Primary end point(s): • Clinical response (clinical success or clinical failure) to study medication at end of therapy, two days after treatment (Day 7 for 1% SB-275833 ointment and Day 9 for 2% sodium fusidate ointment) The hypothesis to be tested by the primary endpoint is that the clinical efficacy of 1% SB-275833 ointment at end of therapy is non-inferior to that of 2% sodium fusidate ointment in the treatment of subjects with impetigo | — |
Countries
Germany, Italy
Outcome results
None listed