The effect of Staphefekt on the skin microbiome, including Staphylococcus aureus, in patients with atopic dermatitis.

• Conditions: atopic dermititis; eczema; 10004018; 10040790

• Registration Number: NL-OMON40588
• Lead Sponsor: Micreos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 16

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. The dynamics of S. aureus after application of Staphefekt on skin/mucosa<br /><br>2. Effect of Staphefekt on disease severity of atopic dermatitis (compared to<br /><br>placebo) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Effect of Staphefekt on other microorganisms on skin/mucosa<br /><br>2. Possible side-effects of Staphefekt</p><br>