An antimicrobial cream for the treatment of impetigo

INTERVENTION: Trade Name: Impetus Cream Product Name: IPTG Cream Product Code: N/A Pharmaceutical Form: Cream INN or Proposed INN: Liquid Paraffin CAS Number: 8012‐95‐1 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 10.0‐ INN or Proposed INN: Isopropyl Myristate CAS Number: 110‐27‐0 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 10.0‐ INN or Proposed INN: Benzalkonium Chloride CAS Number: 63449‐41‐2 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 0.1‐ INN or Proposed INN: Chlorhexidine dihydrochloride CAS Number: 3697‐42‐5 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 0.1‐ Trade Name: Fucidin Cream Product Name: Fucidin Cream Product Code: N/A Pharmaceutical Form: Cream INN or Proposed INN: Fusidic Acid CAS Number: 6990‐06‐3 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 2‐ CONDITION: The condition to be studied is uncomplicated localised primary non‐bullous impetigo, suitable for topical antibacterial therapy alone. ; MedDRA version: 16.1 Level: PT Classification code 10021531 Term: Impetigo System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] SECONDARY OUTCOME: Secondary end point(s): Patients with a clinical response of ‘clinical success’ at Visit 2 (End of Treatment) will be asked to return one week after terminating treatment for a Follow‐Up visit (Visit 3). The secondary efficacy parameter will be the clinical response at this Follow‐Up visit, using the following criteria:; ; Clinical success at Follow‐Up is defined as:; • continued absence of the treated lesions, or; • the treated lesions have become dry without crusts, with or without erythema, or ; • the lesions show improvement (as defined for EOT above).; ; Clinical failure at Follow‐Up is defined as:; • any subject who was a Clinical Success at EOT but has a recurrence (at the same or distant site) or worsening of lesions, or; • any subject who has a clinical outcome of ‘unable to determine’ (e.g. if they are lost to follow‐up).; ; For analysis, any ‘clinical failure’ at (or before) the EOT visit (Visit 2) will be carried forward to the Follow‐Up visit (visit 3). Timepoint(s) of evaluation of this end point: The secondary endpoint will be evaluated one week after the end of treatment, on Day 15 (or on Day 16 or Day 17 when necessary to accommodate clinic/surgery opening times). PRIMARY OUTCOME: Main Objective: The primary objective of the study is to determine whether the new antimicrobial cream is effective (i.e. better than placebo) in the treatment of primary non‐bullous impetigo. ; ; If we can show that the new cream is effective in this indication, it may provide a good alternative treatment and help mitigate the emergent bacterial resistance issues, and stigma, associated with antibiotic usage. Primary end point(s): The Primary Outcome of this trial will be the clinical response, i.e. success or failure (as defined below), as visually assessed by the Investigator at the End of Treatment (EOT) visit (Visit 2). ; ; Clinical success is defined as:; • a total absence of treated lesions, or; • the treated lesions have become dry without crusts, with or without erythema, compared with appearance at baseline, or; • the lesions show improvement (defined as a decrease in the size of the affected area, number of lesions, or both) so that no further antimicrobial therapy is deemed necessary by the Investigator.; ; Clinical failure is defined as: ; • deterioration of condition, or ; • insufficient improvement (i.e. lesions remain crusted and / or have exudate leaving a yellow or honey coloured crust, or the lesion area(s) has increased from baseline, with or without an increase in the number of lesions), so that additional antimicrobial therapy is required.; ; Also note that ‘clinical failure’ prior to the end of treatment will be carried forward to the EOT visit. For example, any patients who stop study treatment, withdraw from the study or use additional treatments prior to the end of their 7 day treatment period because of deterioration of their impetigo, will be considered to have a clinical response of ‘clinical failure’. Secondary Objective: The secondary objective is to determine whether the new cream is as effective as Fucidin Cream (the active comparator) in this indication. A further objective is to obtain additional reassurance on the safety of the new cream in this indication. Timepoint(s) of evaluation of this end point: The primary efficacy evaluation will be after 7 days of treatment, on Day 8 (or on Day 9 or Day 10 when necessary to accommodate clinic/surgery opening times). However, in all cases the treatment will stop after 7 days.; ; INCLUSION CRITERIA: i. Male or female patients aged 18 months and over. ii. Diagnosis of uncomplicated, localised, primary non‐bullous (crusted) impetigo considered, by the Investigator, suitable for treatment with topical antibacterial therapy only. iii. Patients presenting with at least 1, but no more than 10, discrete impetigo lesions. iv. Patients with a total surface area of impetigo involvement not exceeding 100 cm2 (in the case of patients aged 18 years and above) or not exceeding 2% of the total body surface area (in case of patients younger than 18 years). Are the trial subjects under 18? yes Number of subjects for this age range: 162 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5