A trial to investigate if use of an antimicrobial product in the nose of subjects with atopic eczema can remove colonisation with Staphylococcus aureus (a bacteria).

Phase 1

• Conditions: asal colonisation with Staphylococcus aureus; MedDRA version: 17.1Level: LLTClassification code 10069719Term: Bacterial colonisationSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-004183-29-GB
• Lead Sponsor: Dermal Laboratories

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-09
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified