Atopic dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858 MedDRA version: 23.0 Level: LLT Classification code 10084010 Term: Atopic dermatitis flare System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Dicillin (Dicloxacillin)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Dicloxacillin
CAS Number: 3116-76-5
Other descriptive name: Dicillin
Concentration unit: mg milligram(s)
Co
Sponsors
Bispebjerg hospital, Dermato-Venerologisk afdeling, Jacob Pontoppidan Thyssen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA: - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: After all patients have completed the study.;Main Objective: We 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, we 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? ;Primary end point(s): 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 The Total Lesion Symptom Scale (TLSS) score improvement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: After all patients have completed the study and all biopsies, tape strips, swabs and blood samples are analyzed.;Secondary end point(s): The secondary endpoint is to describe changes in the skin microbiome measured as community composition, host - microbial cross-talk, immune response, and the epidermal barrier disruption during i) treatment with systemic dicloxacillin treatment (1000 mg x 3 times a day) and mometasone furoate 0.1% cream once daily ii) treatment with mometasone furoate 0.1% cream once daily iii) cutaneous application of respectively SEB and S. aureus from the patient’s self, compared to vehicle. In addition, we will investigate the changes in itch-NRS, sleep-NRS, pain-NRS, TLSS and EASI score during i) treatment with systemic dicloxacillin treatment (1000 mg x 3 times a day) and mometasone furoate 0.1% cream once daily ii) treatment with mometasone furoate 0.1% cream once daily iii) cutaneous application of respectively SEB and S. aureus from the patient’s self, compared to vehicle. Finally, we aim to investigate the effects of treatment on markers of bone resorption and formation including C-terminal telopeptide of type I collagen (CTX), N-terminal propeptide of type 1 procollagen (P1NP) and parathyroid hormone (PTH), because TCS such as mometasone furoate may increase bone resorption as seen in a large epidemiologic study. | — |
Countries
Denmark
Contacts
Public ContactDermato-Venerologisk afdeling
Biepebjerg Hospital
Outcome results
None listed