atopic dermititis eczema
Conditions
Interventions
30 patients are recruited and characterized. Characterization of patients
includes (1) determination of S. aureus colonization status by screening the
nares, the pharynx and the lesional skin (prefe
Sponsors
Micreos
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Atopic dermatitis of moderate severity. Defined by EASI score performed by the researcher at time of recruitment. 2. > 18 years old 3. At least 2 lesions at similar body sites (similar habitat) suitable for sampling 4. Colonisation of the nares and skin (2 lesions) with S. aureus, defined as having 2 positive cultures with an interval of one week. 5. Loads of Staphylococcus aureus are high enough for quantitative analysis (15-300 colony forming units per plate). Detection limits are based on ISO standards (4833:2003 and 6888-1:1999).
Exclusion criteria
Exclusion criteria: 1. Use of systemic antibiotics or corticosteroids within the last 6 months 2. Use of Methotrexate or immunosuppressive agents 3. Irregular intermittent use of topical or inhaled steroids within the last 6 months 4. Use of topical antibiotics in the previous 7 days 5. Use of Gladskin within the previous 4 weeks 6. Allergy to components of the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The dynamics of S. aureus after application of Staphefekt on skin/mucosa 2. Effect of Staphefekt on disease severity of atopic dermatitis (compared to placebo) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Effect of Staphefekt on other microorganisms on skin/mucosa 2. Possible side-effects of Staphefekt | — |
Countries
Netherlands
Outcome results
None listed