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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006883-25 | EudraCT Number |
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| Name | Class |
|---|---|
| The Novo Nordic Foundation | OTHER |
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The goal of this clinical trial is to compare and evaluate in patients with atopic dermatitis. The main questions it aims to answer are:
Participants will meet for two different phases:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dicloxacillin Oral Capsule | Drug | Randomized to either systemic dicloxacillin & elocon or placebo & elocon |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the skin microbiome measured as community composition (beta-diversity) visualised as PCOA plots | Describe changes in the skin microbiome measured as community composition 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 |
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Inclusion Criteria:
EXCLUSION CRITERIA:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacob Thyssen, Professor, MD, DMSc | Contact | 38636173 | jacob.pontoppidan.thyssen@regionh.dk | |
| Amalie Rønnstad, MD | Contact | 25790995 | amalie.thorsti.moeller.roennstad@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Jacob Thyssen, Professor, MD, DMSc | Professor, Department of Dermatology, Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology | Recruiting | Copenhagen NV | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36806068 | Derived | 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. |
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Due to Danish data protection law sharing IPD is not planned. Data outcomes should be anonymized without any recognizable information.
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D004009 | Dicloxacillin |
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D003023 | Cloxacillin |
| D010068 | Oxacillin |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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Randomized Controlled Trial, Double Blinded
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The investigators as well as the participating patients are blinded during the RCT of Dicloxacillin/Placebo & Elocon
| Elocon 0.1 % Topical Cream | Drug | Both groups are treated with elocon for five days. |
|
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| 1 year |
| Changes in the skin microbiome measured as alfa-diversity (Shannon diversity) | Describe changes in the skin microbiome measured as immune response 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 | 1 year |
| Changes in the skin microbiome measured as relative abundance (%) of baterial genera | 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 | 1 year |
| Changes in the amount of cytokines | Describe changes in the epidermal barrier disruption through changes in cytokines (to Il-1a, IL-4, IL-13, IL-1RA, CXCL-9, IL-22, IL-31, IL-8, IL-18, CCL-17, CCL-18, CCL-20, CCL-22, CXCL-10, VEGF-A) 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 | 1 year |
| Changes in itch with peak pruritus 24 hours | Changes in itch on a scale from 0-10 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. | Through study completion, an average of 1 year |
| The effects of treatment on markers of bone resorption and formation with C-terminal telopeptide of type I collagen (CTX) | The investigators aim to investigate the effects of treatment on markers of bone resorption and formation including C-terminal telopeptide of type I collagen (CTX) because TCS such as mometasone furoate may increase bone resorption as seen in a large epidemiologic study. | 1 year |
| The effects of treatment on markers of bone resorption and formation with N-terminal propeptide of type 1 procollagen (P1NP) | The investigators aim to investigate the effects of treatment on markers of bone resorption and formation including N-terminal propeptide of type 1 procollagen (P1NP) because TCS such as mometasone furoate may increase bone resorption as seen in a large epidemiologic study. | 1 year |
| The effects of treatment on markers of bone resorption and formation with parathyroid hormone (PTH) | The investigators aim to investigate the effects of treatment on markers of bone resorption and formation including parathyroid hormone (PTH), because TCS such as mometasone furoate may increase bone resorption as seen in a large epidemiologic study. | 1 year |
| Changes in sleep-Numeric rating scale | Changes in sleep on a numerical rating scale from 0-10 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. | Through study completion, an average of 1 year |
| Changes in pain-Numeric rating scale | Changes in pain on a numerical rating scale from 0-10 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. | Through study completion, an average of 1 year |
| The Eczema Area and Severity Index (EASI) | Changes in 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. | Through study completion, an average of 1 year |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |