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

NCT05578482 Phase 4 UNKNOWN

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.

Details

Lead sponsor	Jacob Pontoppidan Thyssen
Phase	Phase 4
Status	UNKNOWN
Enrolment	45
Start date	2022-10-24
Completion	2023-05

Conditions

• Atopic Dermatitis
• Atopic Dermatitis Eczema
• Atopic Dermatitis Flare

Interventions

• Dicloxacillin Oral Capsule
• Elocon 0.1 % Topical Cream

Primary outcomes

• Change in The Total Lesion Symptom Scale (TLSS) score improvement — Through study completion, an average of 1 year
  The primary endpoint is to describe if addition of systemic dicloxacillin treatment (1000 mg x 3 times a day) to topical treatment with mometasone furoate 0.1% cream once daily increases the rapidity and depth of the treatment response measured as changes in The Total Lesion Symptom Scale (TLSS) score improvement. The score is a numerical scale from 0-15.

Countries

Denmark