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

NCT05578482 | Unknown Phase 4 DMC

• 2 other identifiers: AR-AB-AD2021-006883-25
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Atopic Dermatitis; Atopic Dermatitis Eczema; Atopic Dermatitis Flare

Keywords

Atopic dermatitis; Atopic dermatitis flare; Skin microbiome; Skin barrier markers; RCT; Antibiotics; Topical corticosteroids; Staphylococcus aureus

Outcome Measures

Primary Outcomes (1)

• Change in The Total Lesion Symptom Scale (TLSS) score improvement

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (11)

• Changes in the skin microbiome measured as community composition (beta-diversity) visualised as PCOA plots

  1 year

• Changes in the skin microbiome measured as alfa-diversity (Shannon diversity)

  1 year

• Changes in the skin microbiome measured as relative abundance (%) of baterial genera

  1 year

• Changes in the amount of cytokines

  1 year

• Changes in itch with peak pruritus 24 hours

  Through study completion, an average of 1 year

Study Arms (2)

Dicillin & Elocon

ACTIVE COMPARATOR

20 of the participating patients are randomized to the active arm where systemic dicloxacillin and elocon creme (mometasone furoate 0.1%) is received.

Drug: Dicloxacillin Oral Capsule; Drug: Elocon 0.1 % Topical Cream

Placebo & Elocon

PLACEBO COMPARATOR

20 of the participating patients are randomized to the placebo arm where placebo and elocon creme (mometasone furoate 0.1%) is received.

Drug: Elocon 0.1 % Topical Cream

Interventions

Dicloxacillin Oral Capsule DRUG

Randomized to either systemic dicloxacillin \& elocon or placebo \& elocon

Also known as: Elocon (Mometasone furoate 0.1%)

Dicillin & Elocon

Elocon 0.1 % Topical Cream DRUG

Both groups are treated with elocon for five days.

Also known as: Mometasone furoate 0.1%

Dicillin & Elocon; Placebo & Elocon

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or above
• European ancestry
• AD diagnosis according to Hanifin \& Rajka criteria
• AD for at least 3 years
• AD that is moderate-to-severe defined as an EASI score of ≥ 7
• AD in the sampled location that has an TLSS score of ≥ 5

You may not qualify if:

• Current or present systemic immunosuppressant and/or biological treatment for the past 4 weeks
• Evidence of other concomitant inflammatory skin conditions (e.g., psoriasis or contact dermatitis)
• Evidence of active skin infection that warrants treatment at screening or baseline visit
• Systemic or topical antibiotics in the preceding past 4 weeks
• Use of disinfectants, bleach and potassium permanganate baths at least 2 weeks before sampling
• UV therapy within the last 3 weeks, or pronounced exposure to sunlight in the preceding 2 weeks
• History of any condition (e.g. bleeding diathesis) that may predispose the patient to complications associated with the planned skin biopsy procedures
• Other clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact the patient's ability to participate in the study or to impact the study pharmacodynamic, or safety assessments
• Decreased kidney function (GFR under 60 ml/min)
• Tendency to formation of keloid scars
• Penicillin or mometasone futurate allergy or intolerance
• Pregnancy
• Breast feeding
• Body weight ≤ 40 kg
• AD only located in the face or intimate regions

Sponsors & Collaborators

• Jacob Pontoppidan Thyssen: lead
• The Novo Nordic Foundation: collaborator

Study Sites (1)

Department of Dermatology

Copenhagen NV, 2100, Denmark

RECRUITING

Related Publications (1)

• Ronnstad ATM, Bay L, Ruge IF, Halling AS, Fritz BG, Jakasa I, Luiten R, Kezic S, Thomsen SF, Bjarnsholt T, Thyssen JP. Defining the temporal relationship between the skin microbiome, immune response and skin barrier function during flare and resolution of atopic dermatitis: protocol of a Danish intervention study. BMJ Open. 2023 Feb 17;13(2):e068395. doi: 10.1136/bmjopen-2022-068395.

  PMID: 36806068 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Staphylococcal Infections

Interventions

Dicloxacillin; Mometasone Furoate

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Cloxacillin; Oxacillin; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jacob Thyssen, Professor, MD, DMSc

  Professor, Department of Dermatology, Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Thyssen, Professor, MD, DMSc

CONTACT

38636173; jacob.pontoppidan.thyssen@regionh.dk

Amalie Rønnstad, MD

CONTACT

25790995; amalie.thorsti.moeller.roennstad@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigators as well as the participating patients are blinded during the RCT of Dicloxacillin/Placebo \& Elocon
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Jacob Pontoppidan Thyssen

Model Details: Randomized Controlled Trial, Double Blinded

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 13, 2022
• Study Start: October 24, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)