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

NCT05578482 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-12-21

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • The Novo Nordic Foundation

    collaborator OTHER

  • Jacob Pontoppidan Thyssen

    lead OTHER

Principal Investigators

  • Jacob Thyssen, Professor, MD, DMSc · Professor, Department of Dermatology, Bispebjerg Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-24
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • Denmark

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05578482 on ClinicalTrials.gov