The condition to be studied is uncomplicated localised primary non-bullous impetigo, suitable for topical antibacterial therapy alone. MedDRA version: 20.0 Level: PT Classification code 10021531 Term: Impetigo System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
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/we
Sponsors
Dermal Laboratories Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: i) Patients with a history of intolerance or skin sensitivity to any of the ingredients. ii) Patients with underlying skin disease or trauma with clinical evidence of secondary infection, or a bacterial skin infection that, in the Investigator’s opinion, is not suitable for treatment with topical antibacterial therapy only (e.g. diabetic foot infections, extensive cellulitis, furunculosis, or abscess). iii) Patients with signs and symptoms of systemic infection (e.g. fever with oral temperature above 38.3ºC). iv) Patients who have applied any topical therapeutic agent (including corticosteroids, antibacterials and antifungals) directly to the impetigo lesion(s) within 48 hours prior to study entry. v) Patients who have taken any systemic antibacterial or steroid/corticosteroid treatment within 48 hours prior to study entry. vi) Patients with systemic diseases which, in the opinion of the Investigator, may adversely influence their participation in the trial. vii) Patients who have received any unlicensed drug within the last 30 days or who are scheduled to receive an investigative drug other than the study medication during the period of the study. viii) Patients who are immunocompromised. ix) Female patients who are pregnant or lactating (although there are no particular safety concerns in these patient groups, it is generally inappropriate for them to participate in clinical trials without overriding justification. Negative pregnancy testing will not be necessary, and there are no safety concerns, as such, about female patients potentially conceiving while taking part in the study). x) Patients considered unable or unlikely to attend the necessary follow-up visits at day 8 (or day 9 or 10) and potentially day 15 (or day 16 or 17), which are not part of the standard clinical care. xi) Patients who, in the opinion of the Investigator, have impetigo lesions which may require being covered with gauze, bandages and/or nappies during treatment with the IMP. xii) Patients with another member of the household participating in the study during the same treatment period (this is to avoid possible mix up between assigned treatments). xiii) Employees of the Sponsor or the Investigators, or their immediate family members (partner, offspring, parents, siblings or sibling’s offspring).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;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 or a delegated Nurse Practitioner considered suitably experienced 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 peri | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
United Kingdom
Contacts
Public ContactSue Dean
Dermal Laboratories Ltd
Outcome results
None listed