NCT05578482

Staphylococcus Aureus and The Skin Microbiome During Flare And Resolution Of Atopic Dermatitis

The Pathogenic Role Of Staphylococcus Aureus And The Skin Microbiome During Flare And Resolution Of Atopic Dermatitis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Jacob Pontoppidan Thyssen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare and evaluate in patients with atopic dermatitis. The main questions it aims to answer are: * Does the addition of systemic dicloxacillin to TCS treatment result in a more rapid and deeper treatment response? * Does the addition of systemic dicloxacillin to TCS treatment affect the skin microbiome, the skin barrier and immune response during improvement of AD? * Does topical application of S. aureus or SEB increase the severity and rapidity of a flare? Participants will meet for two different phases: * Phase one will be at randomized controlled trial where patients are randomized to either systemic dicloxacillin + mometasone furoate or placebo + mometasone furoate. * Phase II: Patients will meet for five visits to receive different solutions on the skin including autologous s. aureus and staphylococcal enterotoxin B.

Detailed description

The investigators hypothesize: Use of oral systemic antibiotic treatment with dicloxacillin (1000 mg x 3 times a day) will decrease the time to AD improvement as well as the amount of S. aureus and its toxins and alter the skin microbiome. Specifically, the investigators aim to investigate the following research questions: * RQ1: Does the addition of systemic dicloxacillin to TCS treatment result in a more rapid and deeper treatment response? * RQ2: Does the addition of systemic dicloxacillin to TCS treatment affect the skin microbiome, the skin barrier and immune response during improvement of AD? * RQ3: Does topical application of S. aureus or SEB increase the severity and rapidity of a flare? * RQ4: Does topical application of S. aureus and SEB alter the skin microbiome, the skin barrier and immune response during a flare of AD? * RQ5: Can changes in protein expression or metabolic pathways explain the modulated mechanisms in the host-microbial cross talk of AD?

Conditions

• Atopic Dermatitis
• Atopic Dermatitis Eczema
• Atopic Dermatitis Flare

Interventions

Type	Name	Description
DRUG	Dicloxacillin Oral Capsule	Randomized to either systemic dicloxacillin \& elocon or placebo \& elocon
DRUG	Elocon 0.1 % Topical Cream	Both groups are treated with elocon for five days.

Timeline

• Start date: 2022-10-24
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2022-10-13
• Last updated: 2022-12-21

Locations

1 site across 1 country: Denmark