Nasal colonisation with Staphylococcus aureus MedDRA version: 17.1 Level: LLT Classification code 10069719 Term: Bacterial colonisation System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Dermol Cream
Product Name: DERC
Pharmaceutical Form: Cream
INN or Proposed INN: Benzalkonium Chloride
CAS Number: 63449-41-2
Concentration unit: % (W/W) percent weight/weight
Concentration
Sponsors
Dermal Laboratories
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The principal inclusion criteria are as follows: i) Adult subjects (aged 16 years and above) not meeting any of the exclusion criteria. ii) Subjects diagnosed by the Investigator as having atopic eczema, as defined as; a) Have an itchy skin condition within the past 12 months plus at least three of the following: b) History of flexural involvement c) History of generally dry skin d) Personal history of asthma or allergic rhinitis e) Visible dermatitis involving skin creases f) First onset of signs and symptoms as a child iii) Subjects testing positive for the presence of Staphylococcus aureus in the anterior nares when swabbed on Day -7, with a colony count of greater than 1000 Colony Forming Units (CFU). Are the trial subjects under 18? yes Number of subjects for this age range: 8 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 27 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: The following subjects will be excluded from taking part in the study: i) Subjects with a history of intolerance or skin sensitivity to any of the ingredients of the two IMPs. ii) Subjects with infected eczema or any other infected skin condition. iii) Subjects currently taking, or having taken within the 4 weeks prior to the study start (Day -7), any oral antibiotics, oral corticosteroids or oral immunosuppressants for acute conditions. Subjects that are taking low dose oral corticosteroids for long term, chronic conditions (such as arthritis, inflammatory bowel conditions) or using inhaled corticosteroids (for asthma or COPD) long term will be eligible if in the opinion of the Investigator their medication will not have any impact on the results of the trial. iv) Subjects who are currently using or have used any topical antibiotics in the nose in the two weeks prior to the study start (Day -7). v) Subjects who in the Investigator’s opinion would find nasal administration of the test IMP unacceptable or impracticable. vi) Subjects with nasal piercings. vii) Subjects with current allergic rhinitis, symptoms of cold or flu, nasal polyps or any damage to the nose. viii) Subjects with systemic diseases which, in the opinion of the Investigator, may adversely influence their participation in the trial. ix) Subjects who have received any unlicensed medicine 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. x) Subjects with current or recent heavy use of recreational drugs in the nose that may affect the nasal morphology. xi) Female subjects who are pregnant or lactating (although there are no particular safety concerns in these subject groups, it is generally inappropriate for them to participate in clinical trials without overriding justification). Pregnancy testing is not deemed necessary and therefore will not be performed. xii) Subjects considered unable or unlikely to adhere to the treatment regimen or attend the necessary follow-up visits. xiii) Subjects with another member of the household already enrolled in the study, regardless of whether they have completed their participation. This is to avoid possible mix up between assigned IMPs and to avoid any subjects from seeing both of the study products which could affect blinding. xiv) Subjects with planned elective surgery in the next 8 weeks that may require nasal decolonisation. xv) Employees of Simbec, Dermal Laboratories or an immediate family member (partner, offspring, parents, siblings or sibling’s offspring) of such employees.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective is to determine whether the test cream is more effective than placebo(blank product)at removing Staphylococcus aureus bacteria from the nostrils of individuals with atopic eczema, when instilled into the nostrils 3 times daily for 7 days.;Secondary Objective: The secondary objective is to report on subjects' feedback on whether they find the product to be acceptable to use. The trial will also collect additional information on the rate of re-colonisation in the nose after discontinuing treatment and the percentage of MRSA-colonised patients (determined by nasal swab at Day 1 and 8) for whom eradication occurs on Day 8. ;Primary end point(s): The primary efficacy parameter will be the percentage of subjects whose nasal Staphylococcus aureus is eradicated by the 8th day (i.e. following 7 consecutive days of treatment), as determined by analysis of microbiological swabs for each treatment group. Any randomised subjects who were not confirmed as SA positive in the anterior nares at the Day 1 (pre-treatment) microbiological swabbing will not be included in the primary efficacy analysis. ;Timepoint(s) of evaluation of this end point: Microbiological swabs will be taken on day 1 prior to treatment start and on day 8, following 7 days of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy parameters will be the percentage of subjects reporting that the treatment regimen and method of application is acceptable.;Timepoint(s) of evaluation of this end point: Patients will record their opinion of the product in a patient questionnaire provided, which will be completed after their 7 days of applying the product. | — |
Countries
United Kingdom
Contacts
Public ContactSykes
Dermal Laboratories
Outcome results
None listed